Trial Outcomes & Findings for Evaluation of the Fluoride Dose Response of a Modified In Situ Caries Model (NCT NCT03383783)
NCT ID: NCT03383783
Last Updated: 2019-05-20
Results Overview
The extent of remineralization will be calculated based on the method of \[Gelhard et al., 1979\]. * SMH recovery = (D1-R)/(D1-B) ×100 B = indentation length (µm) of sound enamel specimen at baseline D1 = indentation length (µm) after in vitro demineralization R = indentation length (µm) after intra-oral exposure.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
28 participants
Primary outcome timeframe
Enamel specimens will be evaluated after 14 days of intra-oral exposure
Results posted on
2019-05-20
Participant Flow
1 participant signed the informed consent and attended up to visit 2, but were dropped from the study as they no longer met inclusion criteria, and this occurred before randomization to interventions.
Participant milestones
| Measure |
All Study Participants
This was a 4-way crossover design study. All participants were randomized to receive the following interventions:
Dentifrice fluoride concentrations - 0, 250, 500 and 1100 ppm fluoride of our existing in situ model involving the use of human enamel specimens placed in the buccal flange area of the subjects partial denture with the modified model involving placement of bovine enamel specimens in a denture tooth location.
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
All Study Participants
This was a 4-way crossover design study. All participants were randomized to receive the following interventions:
Dentifrice fluoride concentrations - 0, 250, 500 and 1100 ppm fluoride of our existing in situ model involving the use of human enamel specimens placed in the buccal flange area of the subjects partial denture with the modified model involving placement of bovine enamel specimens in a denture tooth location.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Evaluation of the Fluoride Dose Response of a Modified In Situ Caries Model
Baseline characteristics by cohort
| Measure |
All Study Participants
n=27 Participants
This was a 4-way crossover design study. All participants were randomized to receive the following interventions:
Dentifrice fluoride concentrations - 0, 250, 500 and 1100 ppm fluoride of our existing in situ model involving the use of human enamel specimens placed in the buccal flange area of the subjects partial denture with the modified model involving placement of bovine enamel specimens in a denture tooth location.
|
|---|---|
|
Age, Continuous
|
67 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/African-American
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Enamel specimens will be evaluated after 14 days of intra-oral exposureThe extent of remineralization will be calculated based on the method of \[Gelhard et al., 1979\]. * SMH recovery = (D1-R)/(D1-B) ×100 B = indentation length (µm) of sound enamel specimen at baseline D1 = indentation length (µm) after in vitro demineralization R = indentation length (µm) after intra-oral exposure.
Outcome measures
| Measure |
Bovine Specimens 0 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 0 parts per million fluoride dentifrice.
|
Bovine Specimens 250 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 250 parts per million fluoride dentifrice.
|
Bovine Specimens 500 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 500 parts per million fluoride dentifrice.
|
Bovine Specimens 1100 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 1100 parts per million fluoride dentifrice.
|
Human Specimens 0 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 0 parts per million fluoride dentifrice.
|
Human Specimens 250 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 250 parts per million fluoride dentifrice.
|
Human Specimens 500 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 500 parts per million fluoride dentifrice.
|
Human Specimens 1100 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 1100 parts per million fluoride dentifrice.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage Surface Microhardness Recovery (%SMH)
|
13.96 Percent Surface Microhardness Recovery
Interval 8.0 to 20.29
|
30.59 Percent Surface Microhardness Recovery
Interval 22.26 to 38.71
|
40.74 Percent Surface Microhardness Recovery
Interval 31.68 to 50.34
|
48.28 Percent Surface Microhardness Recovery
Interval 37.15 to 57.86
|
7.42 Percent Surface Microhardness Recovery
Interval 2.55 to 12.45
|
16.27 Percent Surface Microhardness Recovery
Interval 10.33 to 22.51
|
21.59 Percent Surface Microhardness Recovery
Interval 13.67 to 29.64
|
26.75 Percent Surface Microhardness Recovery
Interval 18.19 to 35.29
|
SECONDARY outcome
Timeframe: Enamel specimens will be evaluated after 14 days of intra-oral exposureThe %NAR will be calculated by the method of Corpron \[Corpron et al., 1986\]: * Net Acid Resistance = \[(D1-D2) / (D1-B)\] \* 100 B= Indentation length (µm) of sound enamel at baseline D1= Indentation length (µm) after first in vitro demineralization D2= Indentation length (µm) after second in vitro demineralization
Outcome measures
| Measure |
Bovine Specimens 0 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 0 parts per million fluoride dentifrice.
|
Bovine Specimens 250 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 250 parts per million fluoride dentifrice.
|
Bovine Specimens 500 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 500 parts per million fluoride dentifrice.
|
Bovine Specimens 1100 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 1100 parts per million fluoride dentifrice.
|
Human Specimens 0 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 0 parts per million fluoride dentifrice.
|
Human Specimens 250 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 250 parts per million fluoride dentifrice.
|
Human Specimens 500 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 500 parts per million fluoride dentifrice.
|
Human Specimens 1100 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 1100 parts per million fluoride dentifrice.
|
|---|---|---|---|---|---|---|---|---|
|
Net Acid Resistance (NAR)
|
-22.68 % Net Acid Resistance
Interval -36.71 to -11.7
|
11.43 % Net Acid Resistance
Interval 1.92 to 20.42
|
18.66 % Net Acid Resistance
Interval 8.17 to 27.63
|
31.79 % Net Acid Resistance
Interval 17.57 to 42.9
|
-18.60 % Net Acid Resistance
Interval -28.62 to -9.55
|
1.99 % Net Acid Resistance
Interval -6.31 to 9.43
|
8.31 % Net Acid Resistance
Interval -1.36 to 16.9
|
16.87 % Net Acid Resistance
Interval 8.91 to 23.95
|
SECONDARY outcome
Timeframe: Enamel specimens will be evaluated after 14 days of intra-oral exposureUsing the data from the four centrally located enamel specimens, the equation used will compare explicitly the reduction in SMH brought by the first and second acid challenges: * Comparative Acid Resistance = \[(D2-R) / (D1-B)\] \* 100 B= Indentation length (µm) of sound enamel at baseline R= Indentation length (µm) of enamel after in situ remineralization D1= Indentation length (µm) after first in vitro demineralization D2= Indentation length (µm) after second in vitro demineralization
Outcome measures
| Measure |
Bovine Specimens 0 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 0 parts per million fluoride dentifrice.
|
Bovine Specimens 250 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 250 parts per million fluoride dentifrice.
|
Bovine Specimens 500 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 500 parts per million fluoride dentifrice.
|
Bovine Specimens 1100 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 1100 parts per million fluoride dentifrice.
|
Human Specimens 0 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 0 parts per million fluoride dentifrice.
|
Human Specimens 250 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 250 parts per million fluoride dentifrice.
|
Human Specimens 500 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 500 parts per million fluoride dentifrice.
|
Human Specimens 1100 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 1100 parts per million fluoride dentifrice.
|
|---|---|---|---|---|---|---|---|---|
|
Comparative Acid Resistance (CAR)
|
36.42 % Comparative Acid Resistance
Interval 23.87 to 51.03
|
19.20 % Comparative Acid Resistance
Interval 11.28 to 27.99
|
22.16 % Comparative Acid Resistance
Interval 13.0 to 32.82
|
16.27 % Comparative Acid Resistance
Interval 8.98 to 24.46
|
25.82 % Comparative Acid Resistance
Interval 18.14 to 33.79
|
14.31 % Comparative Acid Resistance
Interval 9.74 to 19.53
|
13.33 % Comparative Acid Resistance
Interval 8.59 to 18.82
|
9.71 % Comparative Acid Resistance
Interval 4.98 to 14.53
|
SECONDARY outcome
Timeframe: Enamel specimens will be evaluated after 14 days of intra-oral exposureThe amount of fluoride-uptake by enamel will be calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as µg F/cm2.
Outcome measures
| Measure |
Bovine Specimens 0 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 0 parts per million fluoride dentifrice.
|
Bovine Specimens 250 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 250 parts per million fluoride dentifrice.
|
Bovine Specimens 500 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 500 parts per million fluoride dentifrice.
|
Bovine Specimens 1100 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 1100 parts per million fluoride dentifrice.
|
Human Specimens 0 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 0 parts per million fluoride dentifrice.
|
Human Specimens 250 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 250 parts per million fluoride dentifrice.
|
Human Specimens 500 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 500 parts per million fluoride dentifrice.
|
Human Specimens 1100 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 1100 parts per million fluoride dentifrice.
|
|---|---|---|---|---|---|---|---|---|
|
Enamel Fluoride Uptake (EFU)
|
0.96 µg F/cm^2
Interval 0.73 to 1.16
|
2.25 µg F/cm^2
Interval 1.94 to 2.56
|
2.69 µg F/cm^2
Interval 2.35 to 2.97
|
2.98 µg F/cm^2
Interval 2.62 to 3.27
|
0.96 µg F/cm^2
Interval 0.77 to 1.15
|
2.14 µg F/cm^2
Interval 1.9 to 2.38
|
2.50 µg F/cm^2
Interval 2.32 to 2.71
|
2.73 µg F/cm^2
Interval 2.48 to 2.94
|
SECONDARY outcome
Timeframe: Enamel specimens will be evaluated after 14 days of intra-oral exposureLesions will be analyzed after in situ demineralization and the following three parameters calculated: 1. Integrated Mineral Loss - ∆Z= \[(lesion depth x 87) - area under the curve\*\] 2. Lesion Depth - L (83% mineral i.e. 95% of the mineral content of sound enamel) 3. Maximum mineral density at the surface-zone - SZmax
Outcome measures
| Measure |
Bovine Specimens 0 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 0 parts per million fluoride dentifrice.
|
Bovine Specimens 250 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 250 parts per million fluoride dentifrice.
|
Bovine Specimens 500 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 500 parts per million fluoride dentifrice.
|
Bovine Specimens 1100 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 1100 parts per million fluoride dentifrice.
|
Human Specimens 0 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 0 parts per million fluoride dentifrice.
|
Human Specimens 250 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 250 parts per million fluoride dentifrice.
|
Human Specimens 500 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 500 parts per million fluoride dentifrice.
|
Human Specimens 1100 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 1100 parts per million fluoride dentifrice.
|
|---|---|---|---|---|---|---|---|---|
|
Transverse Microradiography (TMR) - Integrated Mineral Loss - ∆Z
|
1240 Integrated Mineral Loss - ∆Z
Interval 948.0 to 1621.0
|
902 Integrated Mineral Loss - ∆Z
Interval 710.0 to 1136.0
|
664 Integrated Mineral Loss - ∆Z
Interval 546.0 to 803.0
|
684 Integrated Mineral Loss - ∆Z
Interval 552.0 to 841.0
|
1526 Integrated Mineral Loss - ∆Z
Interval 1250.0 to 1832.0
|
912 Integrated Mineral Loss - ∆Z
Interval 793.0 to 1033.0
|
901 Integrated Mineral Loss - ∆Z
Interval 800.0 to 1019.0
|
859 Integrated Mineral Loss - ∆Z
Interval 754.0 to 966.0
|
SECONDARY outcome
Timeframe: Enamel specimens will be evaluated after 14 days of intra-oral exposureLesions will be analyzed after in situ demineralization and the following three parameters calculated: 1. Integrated Mineral Loss - ∆Z= \[(lesion depth x 87) - area under the curve\*\] 2. Lesion Depth - L (83% mineral i.e. 95% of the mineral content of sound enamel) 3. Maximum mineral density at the surface-zone - SZmax
Outcome measures
| Measure |
Bovine Specimens 0 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 0 parts per million fluoride dentifrice.
|
Bovine Specimens 250 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 250 parts per million fluoride dentifrice.
|
Bovine Specimens 500 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 500 parts per million fluoride dentifrice.
|
Bovine Specimens 1100 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 1100 parts per million fluoride dentifrice.
|
Human Specimens 0 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 0 parts per million fluoride dentifrice.
|
Human Specimens 250 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 250 parts per million fluoride dentifrice.
|
Human Specimens 500 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 500 parts per million fluoride dentifrice.
|
Human Specimens 1100 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 1100 parts per million fluoride dentifrice.
|
|---|---|---|---|---|---|---|---|---|
|
Transverse Microradiography (TMR) - Lesion Depth - L
|
52.01 Micrometers
Interval 40.62 to 65.49
|
41.74 Micrometers
Interval 32.58 to 53.38
|
34.85 Micrometers
Interval 27.39 to 43.65
|
27.31 Micrometers
Interval 22.62 to 32.18
|
60.73 Micrometers
Interval 50.56 to 71.99
|
42.12 Micrometers
Interval 34.28 to 49.8
|
37.38 Micrometers
Interval 31.17 to 45.06
|
36.02 Micrometers
Interval 31.03 to 41.21
|
SECONDARY outcome
Timeframe: Enamel specimens will be evaluated after 14 days of intra-oral exposureLesions will be analyzed after in situ demineralization and the following three parameters calculated: 1. Integrated Mineral Loss - ∆Z= \[(lesion depth x 87) - area under the curve\*\] 2. Lesion Depth - L (83% mineral i.e. 95% of the mineral content of sound enamel) 3. Maximum mineral density at the surface-zone - SZmax (arbitrary unit from TMR software)
Outcome measures
| Measure |
Bovine Specimens 0 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 0 parts per million fluoride dentifrice.
|
Bovine Specimens 250 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 250 parts per million fluoride dentifrice.
|
Bovine Specimens 500 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 500 parts per million fluoride dentifrice.
|
Bovine Specimens 1100 Ppm F
n=27 Participants
This arm group consisted of the two bovine specimens and 1100 parts per million fluoride dentifrice.
|
Human Specimens 0 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 0 parts per million fluoride dentifrice.
|
Human Specimens 250 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 250 parts per million fluoride dentifrice.
|
Human Specimens 500 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 500 parts per million fluoride dentifrice.
|
Human Specimens 1100 Ppm F
n=27 Participants
This arm group consisted of the two human specimens and 1100 parts per million fluoride dentifrice.
|
|---|---|---|---|---|---|---|---|---|
|
Transverse Microradiography (TMR) - Maximum Mineral Density at the Surface-zone
|
62.17 SZmax
Interval 59.59 to 64.44
|
62.54 SZmax
Interval 60.14 to 65.14
|
67.13 SZmax
Interval 63.53 to 70.61
|
65.93 SZmax
Interval 60.31 to 70.88
|
61.22 SZmax
Interval 58.82 to 63.62
|
62.99 SZmax
Interval 60.59 to 65.42
|
61.38 SZmax
Interval 59.32 to 63.24
|
63.66 SZmax
Interval 61.14 to 66.47
|
Adverse Events
0 Ppm F
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
250 Ppm F
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
500 Ppm F
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
1100 Ppm F
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Between Treatment Periods
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Prior to Randomization
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0 Ppm F
n=27 participants at risk
0 parts per million fluoride
|
250 Ppm F
n=27 participants at risk
250 parts per million fluoride
|
500 Ppm F
n=27 participants at risk
500 parts per million fluoride
|
1100 Ppm F
n=27 participants at risk
1100 parts per million fluoride
|
Between Treatment Periods
n=27 participants at risk
Adverse Events that occurred between treatment periods.
|
Prior to Randomization
n=28 participants at risk
Adverse Events that occurred prior to a subject being randomized into the study.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Mouth Erythema
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
7.4%
2/27 • Number of events 3 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
14.8%
4/27 • Number of events 4 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
11.1%
3/27 • Number of events 4 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
17.9%
5/28 • Number of events 5 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Injury, poisoning and procedural complications
Back Pain
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/28 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Gastrointestinal disorders
Cavity
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.6%
1/28 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Infections and infestations
Common Cold
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.6%
1/28 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/28 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/28 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Eye disorders
Dry Eyes
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/28 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Infections and infestations
Enlarged Lymphnode
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/28 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Infections and infestations
Fever
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.6%
1/28 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Gastrointestinal disorders
Gum Tenderness
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/28 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Injury, poisoning and procedural complications
Head Contusion
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.6%
1/28 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Injury, poisoning and procedural complications
Hip Pain
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/28 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.6%
1/28 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Infections and infestations
Infected Cysts
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.7%
1/27 • Number of events 2 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/28 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/28 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Injury, poisoning and procedural complications
Leg Cramps
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.6%
1/28 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Gastrointestinal disorders
Loose Crown
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.6%
1/28 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Gastrointestinal disorders
Lost Filling
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/28 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
7.4%
2/27 • Number of events 2 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
7.4%
2/27 • Number of events 5 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.6%
1/28 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Gastrointestinal disorders
Mucosal White Patch
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/28 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Injury, poisoning and procedural complications
Muscle Stiffness
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.6%
1/28 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.6%
1/28 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Epitaxis
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/28 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Injury, poisoning and procedural complications
Neck Pain
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/28 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Gastrointestinal disorders
Oral Burning Sensation
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/28 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Injury, poisoning and procedural complications
Shoulder Pain
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/28 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/28 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Headache
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.6%
1/28 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Infections and infestations
Sinus Infection
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/28 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Keratosis
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/28 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/28 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Infections and infestations
Swollen Eye Lid
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/28 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.6%
1/28 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Gastrointestinal disorders
Tooth Extraction
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.6%
1/28 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/28 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
1/27 • Number of events 1 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/27 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
0.00%
0/28 • Each participant was monitored for a 3 month period.
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
|
Additional Information
Domenick T Zero, DDS, MS
Oral Health Research Institute
Phone: 317-274-8822
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place