Trial Outcomes & Findings for In Situ Caries of Fluoride Toothpastes (NCT NCT00708123)
NCT ID: NCT00708123
Last Updated: 2013-04-22
Results Overview
%SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: \[(D-R)/ (D-B)\]\*100.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
60 participants
Primary outcome timeframe
Baseline to 14 days
Results posted on
2013-04-22
Participant Flow
Participants were recruited at the clinical site.
Two days, prior to each treatment visit ,participants used a fluoride- free dentifrice twice daily to avoid any carry over effect.
Participant milestones
| Measure |
Sodium Fluoride (NaF) Toothpaste[1350 Parts Per Million(Ppm)F]
Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
|
NaF/Carbopol Toothpaste (1400 Ppm F)
Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
|
NaMFP/NaF Toothpaste (1450 Ppm F)
Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
|
NaF Toothpaste (250 Ppm F)
Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
|
Placebo Toothpaste (0 Ppm F)
Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
|
|---|---|---|---|---|---|
|
Period 5
COMPLETED
|
10
|
10
|
11
|
11
|
10
|
|
Period 5
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Period 1
STARTED
|
12
|
12
|
12
|
12
|
12
|
|
Period 1
COMPLETED
|
12
|
11
|
11
|
11
|
12
|
|
Period 1
NOT COMPLETED
|
0
|
1
|
1
|
1
|
0
|
|
Period 2
STARTED
|
11
|
12
|
12
|
11
|
11
|
|
Period 2
COMPLETED
|
10
|
12
|
12
|
10
|
11
|
|
Period 2
NOT COMPLETED
|
1
|
0
|
0
|
1
|
0
|
|
Period 3
STARTED
|
12
|
10
|
11
|
12
|
10
|
|
Period 3
COMPLETED
|
12
|
10
|
10
|
11
|
10
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
1
|
1
|
0
|
|
Period 4
STARTED
|
10
|
12
|
10
|
10
|
11
|
|
Period 4
COMPLETED
|
10
|
11
|
10
|
10
|
11
|
|
Period 4
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
|
Period 5
STARTED
|
10
|
10
|
11
|
11
|
10
|
Reasons for withdrawal
| Measure |
Sodium Fluoride (NaF) Toothpaste[1350 Parts Per Million(Ppm)F]
Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
|
NaF/Carbopol Toothpaste (1400 Ppm F)
Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
|
NaMFP/NaF Toothpaste (1450 Ppm F)
Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
|
NaF Toothpaste (250 Ppm F)
Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
|
Placebo Toothpaste (0 Ppm F)
Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
|
|---|---|---|---|---|---|
|
Period 1
Protocol Violation
|
0
|
1
|
0
|
1
|
0
|
|
Period 1
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
|
Period 2
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
|
Period 2
Other Reason
|
1
|
0
|
0
|
0
|
0
|
|
Period 3
Lost to Follow-up
|
0
|
0
|
1
|
1
|
0
|
|
Period 4
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
In Situ Caries of Fluoride Toothpastes
Baseline characteristics by cohort
| Measure |
All Study Participants
n=60 Participants
All randomized participants were included for baseline evaluation.
|
|---|---|
|
Age Continuous
|
67.31 years
STANDARD_DEVIATION 9.166 • n=93 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline to 14 daysPopulation: Intent to treat population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to subject drop outs, there are differences in the "n" per treatment group.
%SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: \[(D-R)/ (D-B)\]\*100.
Outcome measures
| Measure |
NaF/Carbopol Toothpaste (1400 Ppm F)
n=54 Participants
Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
|
NaF Toothpaste (1350 Ppm F)
n=53 Participants
Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
|
NaMFP/NaF Toothpaste (1450 Ppm F)
n=54 Participants
Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial dentures from their mouth.
|
NaMFP/NaF Toothpaste (1450 Ppm F)
Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
|
Placebo Toothpaste (0 Ppm F)
Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
|
|---|---|---|---|---|---|
|
Mean Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF) Compared to NaMFP/NaF Toothpaste (1450ppmF)
|
33.54 %SMHR
Standard Error 1.72
|
35.23 %SMHR
Standard Error 1.74
|
29.57 %SMHR
Standard Error 1.72
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 14 daysPopulation: ITT population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop outs, there were differences in the "n" per treatment group.
%SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: \[(D-R)/ (D-B)\]\*100.
Outcome measures
| Measure |
NaF/Carbopol Toothpaste (1400 Ppm F)
n=54 Participants
Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
|
NaF Toothpaste (1350 Ppm F)
n=53 Participants
Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
|
NaMFP/NaF Toothpaste (1450 Ppm F)
n=54 Participants
Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial dentures from their mouth.
|
NaMFP/NaF Toothpaste (1450 Ppm F)
n=54 Participants
Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
|
Placebo Toothpaste (0 Ppm F)
n=54 Participants
Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
|
|---|---|---|---|---|---|
|
Mean %SMHR of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (250ppmF) and Placebo Toothpaste (0ppmF)
|
33.54 %SMHR
Standard Error 1.72
|
35.23 %SMHR
Standard Error 1.74
|
24.98 %SMHR
Standard Error 1.72
|
29.57 %SMHR
Standard Error 1.72
|
22.05 %SMHR
Standard Error 1.73
|
SECONDARY outcome
Timeframe: Baseline to 14 daysPopulation: ITT population: All randomized participants who had a least one post baseline efficacy assessment. Missing data was not imputed. Due to drop outs, there were differences in the "n" per treatment group.
Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores and expressed as ug F/cm2. The difference between treatments was calculated with respect to fluoride uptake by enamel.
Outcome measures
| Measure |
NaF/Carbopol Toothpaste (1400 Ppm F)
n=54 Participants
Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
|
NaF Toothpaste (1350 Ppm F)
n=53 Participants
Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
|
NaMFP/NaF Toothpaste (1450 Ppm F)
n=54 Participants
Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial dentures from their mouth.
|
NaMFP/NaF Toothpaste (1450 Ppm F)
n=54 Participants
Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
|
Placebo Toothpaste (0 Ppm F)
n=54 Participants
Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
|
|---|---|---|---|---|---|
|
Adjusted Mean Change From Baseline in Enamel Fluoride Uptake
|
1283.13 µg*F/cm^2
Standard Error 71.53
|
1333.09 µg*F/cm^2
Standard Error 72.08
|
680.20 µg*F/cm^2
Standard Error 71.48
|
1086.39 µg*F/cm^2
Standard Error 71.42
|
435.58 µg*F/cm^2
Standard Error 71.54
|
Adverse Events
NaF/ Carbopol Toothpaste (1400 Ppm F)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
NaF Toothpaste (1350ppm F)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
NaMFP/NaF Toothpaste (1450 Ppm F)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
NaF Toothpaste (250 Ppm F)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Toothpaste (0 Ppm F)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NaF/ Carbopol Toothpaste (1400 Ppm F)
n=56 participants at risk
Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
|
NaF Toothpaste (1350ppm F)
n=54 participants at risk
Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
|
NaMFP/NaF Toothpaste (1450 Ppm F)
n=55 participants at risk
Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
|
NaF Toothpaste (250 Ppm F)
n=56 participants at risk
Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
|
Placebo Toothpaste (0 Ppm F)
n=54 participants at risk
Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.1%
4/56 • Number of events 4 • All AEs encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
7.4%
4/54 • Number of events 4 • All AEs encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
1.8%
1/55 • Number of events 1 • All AEs encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
1.8%
1/56 • Number of events 1 • All AEs encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
3.7%
2/54 • Number of events 2 • All AEs encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
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