Trial Outcomes & Findings for Evaluation of Plaque Fluid Fluoride Retention From Fluoride Toothpastes (NCT NCT00708305)
NCT ID: NCT00708305
Last Updated: 2015-01-01
Results Overview
To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4hours using trapezoidal rule and natural log transformation was applied due to failure of assumption of normal distribution of data.
COMPLETED
PHASE3
65 participants
Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment
2015-01-01
Participant Flow
Participants were recruited at the clinical site.
There was a four-day wash out prior to each treatment period during which participants used the study fluoride-free toothpaste. Two to three days prior to the start of each treatment visit, participants attended the study site for a dental prophylaxis then discontinued all oral hygiene prior to study treatment visit.
Participant milestones
| Measure |
Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F)
Participants brushed their natural teeth for one timed minute with 1.6 grams (g) of with NaF and 0.4% carbopol toothpaste (1450 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
NaF Toothpaste (1400ppmF)
Participants brushed their natural teeth for one timed minute with 1.6 g NaF toothpaste (1400 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF)
Participants brushed their natural teeth for one timed minute with 1.6 g NaMFP and NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
Placebo Toothpaste (0ppmF)
Participants brushed their natural teeth for one timed minute with 1.6 g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
|---|---|---|---|---|
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Period 1
STARTED
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16
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16
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17
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16
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Period 1
COMPLETED
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15
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16
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16
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14
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Period 1
NOT COMPLETED
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1
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0
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1
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2
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Period 2
STARTED
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15
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15
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16
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15
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Period 2
COMPLETED
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14
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13
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16
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14
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Period 2
NOT COMPLETED
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1
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2
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0
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1
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Period 3
STARTED
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15
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14
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14
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14
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Period 3
COMPLETED
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14
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12
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14
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14
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Period 3
NOT COMPLETED
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1
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2
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0
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0
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Period 4
STARTED
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12
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14
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14
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14
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Period 4
COMPLETED
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12
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14
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14
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14
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Period 4
NOT COMPLETED
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0
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0
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0
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0
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Reasons for withdrawal
| Measure |
Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F)
Participants brushed their natural teeth for one timed minute with 1.6 grams (g) of with NaF and 0.4% carbopol toothpaste (1450 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
NaF Toothpaste (1400ppmF)
Participants brushed their natural teeth for one timed minute with 1.6 g NaF toothpaste (1400 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF)
Participants brushed their natural teeth for one timed minute with 1.6 g NaMFP and NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
Placebo Toothpaste (0ppmF)
Participants brushed their natural teeth for one timed minute with 1.6 g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
|---|---|---|---|---|
|
Period 1
Protocol Violation
|
1
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0
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1
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0
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Period 1
Other Reason
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0
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0
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0
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2
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Period 2
Lost to Follow-up
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0
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1
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0
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0
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Period 2
Protocol Violation
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0
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1
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0
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0
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Period 2
Other Reason
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1
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0
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0
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1
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Period 3
Protocol Violation
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0
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2
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0
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0
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Period 3
Other Reason
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1
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0
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0
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0
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Baseline Characteristics
Evaluation of Plaque Fluid Fluoride Retention From Fluoride Toothpastes
Baseline characteristics by cohort
| Measure |
Overall Study
n=65 Participants
All randomized participants
|
|---|---|
|
Age, Continuous
|
26.4 years
STANDARD_DEVIATION 6.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatmentPopulation: Per-Protocol (PP) population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the "n" per treatment group. Missing data was not imputed.
To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4hours using trapezoidal rule and natural log transformation was applied due to failure of assumption of normal distribution of data.
Outcome measures
| Measure |
NaF Toothpaste(1450 Ppm F)
n=58 Participants
Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
NaF Toothpaste (1400 Ppm F)
n=57 Participants
Participants brushed their natural teeth for one timed minute with 1.6 g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
NaMFP/NaF Toothpaste (1450ppmF)
Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
Placebo Toothpaste (0ppmF)
Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
|---|---|---|---|---|
|
Natural Log Transformed Area Under the Fluoride Concentration in Plaque Fluid by Time Curve (AUC) Between 0-4 Hours
|
0.54 ln(μg*F*minutes/cm^2)
Standard Error 0.086
|
0.54 ln(μg*F*minutes/cm^2)
Standard Error 0.087
|
—
|
—
|
SECONDARY outcome
Timeframe: Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatmentPopulation: Per-Protocol (PP) population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the "n" per treatment group. Missing data was not imputed.
To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4 hours using trapezoidal rule and natural log transformation was applied.due to failure of assumption of normal distribution of data.
Outcome measures
| Measure |
NaF Toothpaste(1450 Ppm F)
n=58 Participants
Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
NaF Toothpaste (1400 Ppm F)
n=57 Participants
Participants brushed their natural teeth for one timed minute with 1.6 g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
NaMFP/NaF Toothpaste (1450ppmF)
n=58 Participants
Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
Placebo Toothpaste (0ppmF)
n=56 Participants
Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
|---|---|---|---|---|
|
Natural Log Transformed AUC for Fluoride Concentration in Plaque Fluid Between 0-4 Hours
|
0.54 ln(μg*F*minutes/cm^2)
Standard Error 0.086
|
0.54 ln(μg*F*minutes/cm^2)
Standard Error 0.087
|
0.05 ln(μg*F*minutes/cm^2)
Standard Error 0.086
|
-0.90 ln(μg*F*minutes/cm^2)
Standard Error 0.087
|
SECONDARY outcome
Timeframe: Plaque samples were collected at baseline, 15 minutes post single application of study treatmentPopulation: PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the "n" per treatment group. Missing data was not imputed.
Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.
Outcome measures
| Measure |
NaF Toothpaste(1450 Ppm F)
n=58 Participants
Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
NaF Toothpaste (1400 Ppm F)
n=59 Participants
Participants brushed their natural teeth for one timed minute with 1.6 g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
NaMFP/NaF Toothpaste (1450ppmF)
n=60 Participants
Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
Placebo Toothpaste (0ppmF)
n=58 Participants
Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
|---|---|---|---|---|
|
Change From Baseline in Fluoride Concentration at 15 Minutes After Brushing With Study Treatments
|
2.00 μg*F/g
Full Range 4.586 • Interval 0.1 to 21.7
|
1.56 μg*F/g
Full Range 2.806 • Interval 0.1 to 16.0
|
0.76 μg*F/g
Full Range 1.633 • Interval 0.1 to 7.2
|
0.03 μg*F/g
Full Range 0.083 • Interval -0.3 to 0.4
|
SECONDARY outcome
Timeframe: Plaque samples were collected at baseline, 30 minutes post single application of study treatmentPopulation: PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the "n" per treatment group. Missing data was not imputed.
Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.
Outcome measures
| Measure |
NaF Toothpaste(1450 Ppm F)
n=58 Participants
Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
NaF Toothpaste (1400 Ppm F)
n=58 Participants
Participants brushed their natural teeth for one timed minute with 1.6 g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
NaMFP/NaF Toothpaste (1450ppmF)
n=60 Participants
Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
Placebo Toothpaste (0ppmF)
n=58 Participants
Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
|---|---|---|---|---|
|
Change From Baseline in Fluoride Concentration at 30 Minutes Post Brushing With Study Treatments
|
0.71 μg*F/g
Interval 0.0 to 7.7
|
0.72 μg*F/g
Interval 0.0 to 14.9
|
0.28 μg*F/g
Interval 0.0 to 4.7
|
0.02 μg*F/g
Interval -0.3 to 0.3
|
SECONDARY outcome
Timeframe: Plaque samples were collected at baseline, 1 hour post single application of study treatmentPopulation: PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the "n" per treatment group. Missing data was not imputed.
Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.
Outcome measures
| Measure |
NaF Toothpaste(1450 Ppm F)
n=58 Participants
Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
NaF Toothpaste (1400 Ppm F)
n=58 Participants
Participants brushed their natural teeth for one timed minute with 1.6 g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
NaMFP/NaF Toothpaste (1450ppmF)
n=58 Participants
Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
Placebo Toothpaste (0ppmF)
n=58 Participants
Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
|---|---|---|---|---|
|
Change From Baseline in Fluoride Concentration at 1 Hour Post Brushing With Study Treatments
|
0.20 μg*F/g
Interval 0.0 to 3.1
|
0.22 μg*F/g
Interval 0.0 to 6.7
|
0.12 μg*F/g
Interval 0.0 to 1.6
|
0.01 μg*F/g
Interval 0.0 to 0.02
|
SECONDARY outcome
Timeframe: Plaque samples were collected at baseline, 2 hour post single application of study treatmentPopulation: PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the "n" per treatment group. Missing data was not imputed.
Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.
Outcome measures
| Measure |
NaF Toothpaste(1450 Ppm F)
n=58 Participants
Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
NaF Toothpaste (1400 Ppm F)
n=59 Participants
Participants brushed their natural teeth for one timed minute with 1.6 g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
NaMFP/NaF Toothpaste (1450ppmF)
n=58 Participants
Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
Placebo Toothpaste (0ppmF)
n=57 Participants
Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
|---|---|---|---|---|
|
Change From Baseline in Fluoride Concentration at 2 Hours Post Brushing With Study Treatments
|
0.09 μg*F/g
Interval -0.1 to 0.7
|
0.09 μg*F/g
Interval -0.1 to 1.0
|
0.07 μg*F/g
Interval -0.3 to 0.5
|
0.00 μg*F/g
Interval -0.1 to 0.1
|
SECONDARY outcome
Timeframe: Plaque samples were collected at baseline, 4 hours post single application of study treatmentPopulation: PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the "n" per treatment group. Missing data was not imputed.
Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.
Outcome measures
| Measure |
NaF Toothpaste(1450 Ppm F)
n=57 Participants
Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
NaF Toothpaste (1400 Ppm F)
n=57 Participants
Participants brushed their natural teeth for one timed minute with 1.6 g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
NaMFP/NaF Toothpaste (1450ppmF)
n=60 Participants
Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
Placebo Toothpaste (0ppmF)
n=57 Participants
Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
|
|---|---|---|---|---|
|
Change From Baseline in Fluoride Concentration at 4 Hours Post Brushing With Study Treatments
|
0.04 μg*F/g
Interval -0.1 to 0.7
|
0.04 μg*F/g
Interval -0.1 to 1.2
|
0.02 μg*F/g
Interval -0.3 to 0.2
|
-0.01 μg*F/g
Interval -0.1 to 0.1
|
Adverse Events
NaF Toothpaste(1450ppmF)
NaF Toothpaste (1400ppmF)
NaMFP/NaF Toothpaste (1450ppmF)
Placebo Toothpaste (0ppmF)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
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