Trial Outcomes & Findings for The Effect of Experimental Dentifrices on Remineralization of Caries Lesions In-situ (NCT NCT02195583)
NCT ID: NCT02195583
Last Updated: 2015-05-01
Results Overview
Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the Surface Microhardness (SMH) Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was determined prior to the in vitro acid challenge. SMH was determined again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The extent of remineralization was calculated as the % recovery in SMH using the equation: % SMHR= \[(D1-R)/(D1-B)\]\*100 Where B = indentation length (μm) of sound enamel at baseline; D1 = indentation length (μm) after first acid challenge; R = indentation length (μm) after in situ remineralization.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
Baseline to 4 hours
Results posted on
2015-05-01
Participant Flow
Participants were recruited at one clinical study site in the USA.
A total of 64 participants were screened and 62 were randomized.
Participant milestones
| Measure |
Overall Participants
Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 seconds (sec) to create dentifrice slurry. Then swished the slurry around the palatal appliance for 1 minute (min) and 35 sec. Next, they expectorated the slurry, rinsed with 15 milliliter (mL) of tap water for 10 sec and expectorated. There was a 2 day washout period before each treatment period when participants used a non-fluoridated dentifrice.
1. Sodium fluoride (1426 ppm):Non-zinc, 1426ppm fluoride as sodium fluoride in silica base
2. Sodium fluoride (1150 ppm):Non-zinc, 1150ppm fluoride as sodium fluoride in silica base
3. Sodium fluoride (250 ppm):Non-zinc, 250ppm fluoride as sodium fluoride in silica base
4. Sodium fluoride (1426 ppm) + zinc base A:Zinc base A, 1426ppm fluoride as sodium fluoride in silica base
5. Sodium fluoride (1426 ppm) + zinc base B:Zinc base B, 1426ppm fluoride as sodium fluoride in silica base
6. Sodium fluoride (0 ppm):Non-zinc, 0ppm fluoride in silica base
|
|---|---|
|
Overall Study
STARTED
|
62
|
|
Overall Study
Sodium Fluoride (1150 Ppm)
|
57
|
|
Overall Study
Sodium Fluoride (0 Ppm)
|
59
|
|
Overall Study
Sodium Fluoride (1426 Ppm) + Zinc Base A
|
58
|
|
Overall Study
Sodium Fluoride (250 Ppm)
|
55
|
|
Overall Study
Sodium Fluoride (1426 Ppm)
|
59
|
|
Overall Study
Sodium Fluoride (1426 Ppm) + Zinc Base B
|
60
|
|
Overall Study
COMPLETED
|
53
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Overall Participants
Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 seconds (sec) to create dentifrice slurry. Then swished the slurry around the palatal appliance for 1 minute (min) and 35 sec. Next, they expectorated the slurry, rinsed with 15 milliliter (mL) of tap water for 10 sec and expectorated. There was a 2 day washout period before each treatment period when participants used a non-fluoridated dentifrice.
1. Sodium fluoride (1426 ppm):Non-zinc, 1426ppm fluoride as sodium fluoride in silica base
2. Sodium fluoride (1150 ppm):Non-zinc, 1150ppm fluoride as sodium fluoride in silica base
3. Sodium fluoride (250 ppm):Non-zinc, 250ppm fluoride as sodium fluoride in silica base
4. Sodium fluoride (1426 ppm) + zinc base A:Zinc base A, 1426ppm fluoride as sodium fluoride in silica base
5. Sodium fluoride (1426 ppm) + zinc base B:Zinc base B, 1426ppm fluoride as sodium fluoride in silica base
6. Sodium fluoride (0 ppm):Non-zinc, 0ppm fluoride in silica base
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Other Reason
|
2
|
Baseline Characteristics
The Effect of Experimental Dentifrices on Remineralization of Caries Lesions In-situ
Baseline characteristics by cohort
| Measure |
All Randomized Participants
n=62 Participants
All randomized participants were evaluated for baseline characteristics
|
|---|---|
|
Age, Continuous
|
40.7 Years
STANDARD_DEVIATION 12.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 4 hoursPopulation: The primary population for the efficacy analysis was the Per Protocol (PP) population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.
Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the Surface Microhardness (SMH) Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was determined prior to the in vitro acid challenge. SMH was determined again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The extent of remineralization was calculated as the % recovery in SMH using the equation: % SMHR= \[(D1-R)/(D1-B)\]\*100 Where B = indentation length (μm) of sound enamel at baseline; D1 = indentation length (μm) after first acid challenge; R = indentation length (μm) after in situ remineralization.
Outcome measures
| Measure |
Sodium Fluoride (1426 Ppm) + Zinc Base B
n=60 Participants
Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (0 Ppm)
n=59 Participants
Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (1426 Ppm)
n=59 Participants
Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (1150 Ppm)
n=57 Participants
Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (250 Ppm)
n=55 Participants
Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (1426 Ppm) + Zinc Base A
n=58 Participants
Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
|---|---|---|---|---|---|---|
|
Percentage Surface Microhardness Recovery (% SMHR)
|
23.22 Percentage of SMHR
Standard Error 1.159
|
24.78 Percentage of SMHR
Standard Error 1.167
|
32.49 Percentage of SMHR
Standard Error 1.167
|
31.81 Percentage of SMHR
Standard Error 1.182
|
27.56 Percentage of SMHR
Standard Error 1.199
|
22.62 Percentage of SMHR
Standard Error 1.175
|
SECONDARY outcome
Timeframe: Baseline to 4 hoursPopulation: The main population for the secondary efficacy analysis was the PP population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.
The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 micrometer (μm) through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling sample was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram per square centimeter (μg/cm\^2).
Outcome measures
| Measure |
Sodium Fluoride (1426 Ppm) + Zinc Base B
n=60 Participants
Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (0 Ppm)
n=59 Participants
Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (1426 Ppm)
n=59 Participants
Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (1150 Ppm)
n=57 Participants
Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (250 Ppm)
n=55 Participants
Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (1426 Ppm) + Zinc Base A
n=58 Participants
Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
|---|---|---|---|---|---|---|
|
Enamel Fluoride Uptake
|
2.37 microgram per square centimeter(μg/cm^2)
Standard Error 0.082
|
0.98 microgram per square centimeter(μg/cm^2)
Standard Error 0.083
|
2.94 microgram per square centimeter(μg/cm^2)
Standard Error 0.083
|
2.70 microgram per square centimeter(μg/cm^2)
Standard Error 0.084
|
1.85 microgram per square centimeter(μg/cm^2)
Standard Error 0.085
|
2.62 microgram per square centimeter(μg/cm^2)
Standard Error 0.083
|
SECONDARY outcome
Timeframe: Baseline to 4 hoursPopulation: The main population for the secondary efficacy analysis was the PP population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.
Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % NAR was calculated using the equation: % NAR= \[(D1-D2)/(D1-B)\]\*100 where B= Indentation length (μm) of sound enamel at baseline; D1= Indentation length (μm) after first acid challenge and D2= Indentation length (μm) after second acid challenge.
Outcome measures
| Measure |
Sodium Fluoride (1426 Ppm) + Zinc Base B
n=60 Participants
Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (0 Ppm)
n=59 Participants
Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (1426 Ppm)
n=59 Participants
Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (1150 Ppm)
n=57 Participants
Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (250 Ppm)
n=55 Participants
Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (1426 Ppm) + Zinc Base A
n=58 Participants
Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
|---|---|---|---|---|---|---|
|
Percentage Net Acid Resistance (% NAR)
|
-18.98 Percentage of NAR
Standard Error 1.214
|
-50.60 Percentage of NAR
Standard Error 1.224
|
-12.54 Percentage of NAR
Standard Error 1.224
|
-13.45 Percentage of NAR
Standard Error 1.244
|
-17.81 Percentage of NAR
Standard Error 1.266
|
-17.60 Percentage of NAR
Standard Error 1.234
|
SECONDARY outcome
Timeframe: Baseline to 4 hoursPopulation: The main population for the secondary efficacy analysis was the PP population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.
Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % CAR was calculated using the equation: % CAR= \[(D2-R)/(D1-B)\]\*100 where 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 acid challenge; D2= Indentation length (μm) after second acid challenge.
Outcome measures
| Measure |
Sodium Fluoride (1426 Ppm) + Zinc Base B
n=60 Participants
Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (0 Ppm)
n=59 Participants
Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (1426 Ppm)
n=59 Participants
Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (1150 Ppm)
n=57 Participants
Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (250 Ppm)
n=55 Participants
Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (1426 Ppm) + Zinc Base A
n=58 Participants
Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
|---|---|---|---|---|---|---|
|
Percentage Comparative Acid Resistance (% CAR)
|
42.21 Percentage of CAR
Standard Error 1.264
|
75.41 Percentage of CAR
Standard Error 1.274
|
45.00 Percentage of CAR
Standard Error 1.274
|
45.23 Percentage of CAR
Standard Error 1.295
|
45.44 Percentage of CAR
Standard Error 1.319
|
40.29 Percentage of CAR
Standard Error 1.285
|
Adverse Events
Sodium Fluoride (1426 Ppm)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Sodium Fluoride (1150 Ppm)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sodium Fluoride (250 Ppm)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Sodium Fluoride (1426 Ppm) + Zinc Base A
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sodium Fluoride (1426 Ppm) + Zinc Base B
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Sodium Fluoride (0 Ppm)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sodium Fluoride (1426 Ppm)
n=59 participants at risk
Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (1150 Ppm)
n=57 participants at risk
Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (250 Ppm)
n=55 participants at risk
Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (1426 Ppm) + Zinc Base A
n=58 participants at risk
Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (1426 Ppm) + Zinc Base B
n=60 participants at risk
Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (0 Ppm)
n=59 participants at risk
Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/57 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/55 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/58 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
1.7%
1/60 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
Other adverse events
| Measure |
Sodium Fluoride (1426 Ppm)
n=59 participants at risk
Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (1150 Ppm)
n=57 participants at risk
Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (250 Ppm)
n=55 participants at risk
Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (1426 Ppm) + Zinc Base A
n=58 participants at risk
Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (1426 Ppm) + Zinc Base B
n=60 participants at risk
Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
Sodium Fluoride (0 Ppm)
n=59 participants at risk
Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Oral Mucosal Erythema
|
3.4%
2/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/57 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/55 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/58 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
1.7%
1/60 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
3.4%
2/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/57 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
1.8%
1/55 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/58 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/60 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
|
Gastrointestinal disorders
Parotid Gland Enlargement
|
0.00%
0/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/57 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/55 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/58 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
1.7%
1/60 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/57 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
1.8%
1/55 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/58 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
1.7%
1/60 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
1.7%
1/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
|
Infections and infestations
Lymph gland infection
|
1.7%
1/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/57 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/55 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/58 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/60 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/57 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/55 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/58 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/60 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
1.7%
1/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/57 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/55 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/58 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
1.7%
1/60 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
|
Nervous system disorders
Headache
|
0.00%
0/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/57 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
1.8%
1/55 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/58 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/60 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/57 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/55 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/58 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/60 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
1.7%
1/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/57 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
1.8%
1/55 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/58 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/60 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/57 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/55 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
1.7%
1/58 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/60 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/57 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
1.8%
1/55 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/58 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/60 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
1.8%
1/57 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/55 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/58 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/60 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
0.00%
0/59 • Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER