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CompletedNCT00708305Updated Jan 1, 2015Results posted

Evaluation of Plaque Fluid Fluoride Retention From Fluoride Toothpastes

A Phase 3 interventional study of Sodium Fluoride (NaF) and Placebo in Dental Caries, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-01.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to investigate the efficacy of different sodium fluoride (NaF) containing toothpastes in prevention of dental caries. Change from baseline fluoride data at various time points up to four hours after a single brushing with NaF containing toothpastes will be evaluated.

Read the detailed description

Topical fluorides in a wide variety of delivery systems have been proven to be clinically effective in the prevention of dental caries. It is generally agreed that fluoride has its anti-caries effect mainly by decreasing the rate of enamel demineralization and enhancing the rate of enamel remineralization. There is a general consensus that level of fluoride in plaque fluid, may be directly related to the anti caries effects of fluoride. Also, fluoride levels in the oral fluids decrease rapidly after topical fluoride application, mainly due to the diluting and washing effect of saliva followed by periodic swallowing. To evaluate fluoride content, plaque samples will be collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride will be calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis.

02

Conditions studied

  • Dental Caries

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Keywords

  • toothpaste
  • plaque fluid
  • fluoride
03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's enrollment of 65 is close to the median of 60 across 916 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age:Age 18 through 65 years.
  2. General Health: Good general health with (in the opinion of the investigator) no clinically significant and/or relevant abnormalities of medical history or oral examination, specifically including diabetes or hypoglycemia.
  3. Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.
  4. Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
  5. Oral: a) Currently living in the Indianapolis, Indiana area and not taking fluoride supplements. b) Have a normal stimulated (= 0.8 ml/min) and unstimulated (= 0.2 ml/min) salivary flow rate. c) Have a full complement of natural teeth with the exception of third molars and teeth extracted for orthodontic reasons. Participants natural teeth must have at least one surface free of restoration in each interproximal embrasure. d) Produce at least 6mg of plaque at Screening Visit 2.

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. No pregnancy test will be required.
  2. Breast-feeding:Women who are breast-feeding.
  3. Medical History:Current or relevant history of any serious, severe or unstable physical or psychiatric illness that would make the subject unlikely to fully complete the study or any that increases the risk to the subject.
  4. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
  5. Clinical Study/Experimental Medication:Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit 1 at the start of the study with the exception of those participating in GSKCH study Z3170476.
  6. Medication: a) Currently taking antibiotics or have taken antibiotics in the two weeks prior to any treatment visit or during the study. b) Has a medical condition that would require prophylactic antibiotics prior to a dental cleaning.
  7. Dental: a) Current active caries or moderate to severe periodontal disease that may compromise the health of the participants or the study. b) Current use of chlorhexidine mouthrinse.
  8. Personnel: An employee of the sponsor or the study site who is directly involved in the conduct of the study.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
65 participants (actual)

Study arms

  • Experimental
    NaF toothpaste (1450 parts per million [ppm] fluoride [F])

    Participants brushed for one timed minute with 1.6g of NaF/silica and 0.4 percent carbopol toothpaste containing 1450ppmF as NaF. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.

    Drug: Sodium Fluoride (NaF)

  • Active comparator
    NaF toothpaste (1400ppmF)

    Participants brushed for one timed minute with 1.6g of NaF toothpaste containing 1400ppmF as NaF. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.

    Drug: Sodium Fluoride (NaF)

  • Active comparator
    Sodium monofluorophosphate (NaMFP)/ NaF toothpaste (1450ppmF))

    Participants brushed for one timed minute with 1.6g of NaMFP/NaF toothpaste containing 1450ppmF from NaMFP and NaF. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.

    Drug: Sodium Fluoride (NaF)

  • Placebo comparator
    Placebo toothpaste (0ppmF)

    Participants brushed for one timed minute with 1.6g of fluoride free toothpaste. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.

    Drug: Placebo

Interventions

  • DrugSodium Fluoride (NaF)

    Different fluoride toothpastes containing between 1400ppmF - 1450ppmF of fluoride as NaF

    Also known as: fluoride

  • DrugPlacebo

    Fluoride free toothpaste (0ppmF)

06

What researchers measure

Primary outcomes

  1. Natural Log Transformed Area Under the Fluoride Concentration in Plaque Fluid by Time Curve (AUC) Between 0-4 Hours

    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.

    Time frame: Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment

Secondary outcomes

  1. Natural Log Transformed AUC for Fluoride Concentration in Plaque Fluid Between 0-4 Hours

    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.

    Time frame: Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment

  2. Change From Baseline in Fluoride Concentration at 15 Minutes After Brushing With Study Treatments

    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.

    Time frame: Plaque samples were collected at baseline, 15 minutes post single application of study treatment

  3. Change From Baseline in Fluoride Concentration at 30 Minutes Post Brushing With Study Treatments

    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.

    Time frame: Plaque samples were collected at baseline, 30 minutes post single application of study treatment

  4. Change From Baseline in Fluoride Concentration at 1 Hour Post Brushing With Study Treatments

    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.

    Time frame: Plaque samples were collected at baseline, 1 hour post single application of study treatment

  5. Change From Baseline in Fluoride Concentration at 2 Hours Post Brushing With Study Treatments

    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.

    Time frame: Plaque samples were collected at baseline, 2 hour post single application of study treatment

  6. Change From Baseline in Fluoride Concentration at 4 Hours Post Brushing With Study Treatments

    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.

    Time frame: Plaque samples were collected at baseline, 4 hours post single application of study treatment

07

Results

Posted Jun 10, 2013

Participant flow

Participants were recruited at the clinical site.

Period 1
Participant flow — Period 1
MilestoneSodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F)NaF Toothpaste (1400ppmF)Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF)Placebo Toothpaste (0ppmF)
Started16161716
Completed15161614
Not completed1012
Withdrew: Protocol violation1010
Withdrew: Other reason0002
Period 2
Participant flow — Period 2
MilestoneSodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F)NaF Toothpaste (1400ppmF)Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF)Placebo Toothpaste (0ppmF)
Started15151615
Completed14131614
Not completed1201
Withdrew: Lost to follow-up0100
Withdrew: Protocol violation0100
Withdrew: Other reason1001
Period 3
Participant flow — Period 3
MilestoneSodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F)NaF Toothpaste (1400ppmF)Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF)Placebo Toothpaste (0ppmF)
Started15141414
Completed14121414
Not completed1200
Withdrew: Protocol violation0200
Withdrew: Other reason1000
Period 4
Participant flow — Period 4
MilestoneSodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F)NaF Toothpaste (1400ppmF)Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF)Placebo Toothpaste (0ppmF)
Started12141414
Completed12141414
Not completed0000

Outcome measures

PrimaryNatural Log Transformed Area Under the Fluoride Concentration in Plaque Fluid by Time Curve (AUC) Between 0-4 Hours

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.

Time frame:
Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment
Reported as:
Least squares mean · ln(μg*F*minutes/cm^2)
Natural Log Transformed Area Under the Fluoride Concentration in Plaque Fluid by Time Curve (AUC) Between 0-4 Hours
ln(μg*F*minutes/cm^2)NaF Toothpaste(1450 Ppm F)NaF Toothpaste (1400 Ppm F)
Natural Log Transformed Area Under the Fluoride Concentration in Plaque Fluid by Time Curve (AUC) Between 0-4 Hours0.54 ± 0.0860.54 ± 0.087
Statistical analysis
  • NaF Toothpaste(1450 Ppm F) vs NaF Toothpaste (1400 Ppm F) · ANCOVA · p = 0.9762 (No adjustment was made for multiple comparisons as the primary comparison was predefined.) · Adjusted mean difference: 0.00 · 95% CI -0.21 to 0.20Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
SecondaryNatural Log Transformed AUC for Fluoride Concentration in Plaque Fluid Between 0-4 Hours

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.

Time frame:
Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment
Reported as:
Log mean · ln(μg*F*minutes/cm^2)
Natural Log Transformed AUC for Fluoride Concentration in Plaque Fluid Between 0-4 Hours
ln(μg*F*minutes/cm^2)NaF Toothpaste(1450ppmF)NaF Toothpaste (1400ppmF)NaMFP/NaF Toothpaste (1450ppmF)Placebo Toothpaste (0ppmF)
Natural Log Transformed AUC for Fluoride Concentration in Plaque Fluid Between 0-4 Hours0.54 ± 0.0860.54 ± 0.0870.05 ± 0.086-0.90 ± 0.087
Statistical analysis
  • NaF Toothpaste(1450ppmF) vs NaMFP/NaF Toothpaste (1450ppmF) · ANCOVA · p = <0.0001 (No adjustment was made for multiple comparisons as the comparisons were predefined.) · Adjusted mean difference: 0.49 · 95% CI 0.28 to 0.70Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste(1450ppmF) vs Placebo Toothpaste (0ppmF) · ANCOVA · p = <0.0001 (No adjustment was made for multiple comparisons because the comparisons were predefined.) · Adjusted mean difference: 1.44 · 95% CI 1.23 to 1.65Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste (1400ppmF) vs NaMFP/NaF Toothpaste (1450ppmF) · ANCOVA · p = <0.0001 (No adjustment was made for multiple comparisons because the comparisons were predefined.) · Adjusted mean difference: 0.49 · 95% CI 0.28 to 0.70Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste (1400ppmF) vs Placebo Toothpaste (0ppmF) · ANCOVA · p = <0.0001 (No adjustment was made for multiple comparisons because the comparison was predefined.) · Adjusted mean difference: 1.44 · 95% CI 1.23 to 1.65Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaMFP/NaF Toothpaste (1450ppmF) vs Placebo Toothpaste (0ppmF) · ANCOVA · p = <0.0001 (No adjustment was made for multiple comparisons as the comparisons were predefined.) · Adjusted mean difference: 0.95 · 95% CI 0.74 to 1.16Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
SecondaryChange From Baseline in Fluoride Concentration at 15 Minutes After Brushing With Study Treatments

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.

Time frame:
Plaque samples were collected at baseline, 15 minutes post single application of study treatment
Reported as:
Median · μg*F/g
Change From Baseline in Fluoride Concentration at 15 Minutes After Brushing With Study Treatments
μg*F/gNaF Toothpaste(1450ppmF)NaF Toothpaste (1400ppmF)NaMFP/NaF Toothpaste (1450ppmF)Placebo Toothpaste (0ppmF)
Change From Baseline in Fluoride Concentration at 15 Minutes After Brushing With Study Treatments2.00 ± 4.5861.56 ± 2.8060.76 ± 1.6330.03 ± 0.083
Statistical analysis
  • NaF Toothpaste(1450ppmF) vs NaF Toothpaste (1400ppmF) · Wilcoxon Signed Rank Test · p = 0.0151 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): 0.83 · 95% CI 0.12 to 1.72Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste(1450ppmF) vs NaMFP/NaF Toothpaste (1450ppmF) · Wilcoxon Signed Rank Test · p = <0.0001 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): 1.36 · 95% CI 0.69 to 2.36Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste(1450ppmF) vs Placebo Toothpaste (0ppmF) · Wilcoxon Signed Rank Test · p = <0.0001 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): 3.01 · 95% CI 2.06 to 4.05Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste (1400ppmF) vs NaMFP/NaF Toothpaste (1450ppmF) · Wilcoxon Signed Rank Test · p = <0.0001 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): 0.75 · 95% CI 0.41 to 1.27Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste (1400ppmF) vs Placebo Toothpaste (0ppmF) · Wilcoxon Signed Rank Test · p = <0.0001 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): 2.10 · 95% CI 1.50 to 2.74Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaMFP/NaF Toothpaste (1450ppmF) vs Placebo Toothpaste (0ppmF) · Wilcoxon Signed Rank Test · p = <0.0001 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): 1.01 · 95% CI 0.73 to 1.35Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
SecondaryChange From Baseline in Fluoride Concentration at 30 Minutes Post Brushing With Study Treatments

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.

Time frame:
Plaque samples were collected at baseline, 30 minutes post single application of study treatment
Reported as:
Median · μg*F/g
Change From Baseline in Fluoride Concentration at 30 Minutes Post Brushing With Study Treatments
μg*F/gNaF Toothpaste(1450ppmF)NaF Toothpaste (1400ppmF)NaMFP/NaF Toothpaste (1450ppmF)Placebo Toothpaste (0ppmF)
Change From Baseline in Fluoride Concentration at 30 Minutes Post Brushing With Study Treatments0.71 (0.0 to 7.7)0.72 (0.0 to 14.9)0.28 (0.0 to 4.7)0.02 (-0.3 to 0.3)
Statistical analysis
  • NaF Toothpaste(1450ppmF) vs NaF Toothpaste (1400ppmF) · Wilcoxon Signed Rank Test · p = 0.5545 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): 0.08 · 95% CI -0.22 to 0.47Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste(1450ppmF) vs NaMFP/NaF Toothpaste (1450ppmF) · Wilcoxon Signed Rank Test · p = 0.0003 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): 0.40 · 95% CI 0.15 to 0.71Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste(1450ppmF) vs Placebo Toothpaste (0ppmF) · Wilcoxon Signed Rank Test · p = <0.0001 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): 0.91 · 95% CI 0.58 to 1.56Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste (1400ppmF) vs NaMFP/NaF Toothpaste (1450ppmF) · Wilcoxon Signal Rank Test · p = <0.0001 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): 0.36 · 95% CI 0.15 to 0.68Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste (1400ppmF) vs Placebo Toothpaste (0ppmF) · Wilcoxon Signed Rank Test · p = <0.0001 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): 0.91 · 95% CI 0.58 to 1.35Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaMFP/NaF Toothpaste (1450ppmF) vs Placebo Toothpaste (0ppmF) · Wilcoxon Signed Rank Test · p = <0.0001 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): 0.37 · 95% CI 0.26 to 0.56Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
SecondaryChange From Baseline in Fluoride Concentration at 1 Hour Post Brushing With Study Treatments

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.

Time frame:
Plaque samples were collected at baseline, 1 hour post single application of study treatment
Reported as:
Median · μg*F/g
Change From Baseline in Fluoride Concentration at 1 Hour Post Brushing With Study Treatments
μg*F/gNaF Toothpaste(1450ppmF)NaF Toothpaste (1400ppmF)NaMFP/NaF Toothpaste (1450ppmF)Placebo Toothpaste (0ppmF)
Change From Baseline in Fluoride Concentration at 1 Hour Post Brushing With Study Treatments0.20 (0.0 to 3.1)0.22 (0.0 to 6.7)0.12 (0.0 to 1.6)0.01 (0.00 to 0.02)
Statistical analysis
  • NaF Toothpaste(1450ppmF) vs NaF Toothpaste (1400ppmF) · Wilcoxon Signed Rank Test · p = 0.6865 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): -0.02 · 95% CI -0.13 to 0.08Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste(1450ppmF) vs NaMFP/NaF Toothpaste (1450ppmF) · Wilcoxon Signed Rank Test · p = 0.1756 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): 0.04 · 95% CI -0.02 to 0.12Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste(1450ppmF) vs Placebo Toothpaste (0ppmF) · Wilcoxon Signed Rank Test · p = <0.0001 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): 0.24 · 95% CI 0.16 to 0.38Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste (1400ppmF) vs NaMFP/NaF Toothpaste (1450ppmF) · Wilcoxon Signed Rank Test · p = 0.0023 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): 0.11 · 95% CI 0.04 to 0.22Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste (1400ppmF) vs Placebo Toothpaste (0ppmF) · Wilcoxon Signed Rank Test · p = <0.0001 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): 0.34 · 95% CI 0.22 to 0.51Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaMFP/NaF Toothpaste (1450ppmF) vs Placebo Toothpaste (0ppmF) · Wilcoxon Signed Rank Test · p = <0.0001 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): 0.18 · 95% CI 0.12 to 0.25Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
SecondaryChange From Baseline in Fluoride Concentration at 2 Hours Post Brushing With Study Treatments

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.

Time frame:
Plaque samples were collected at baseline, 2 hour post single application of study treatment
Reported as:
Median · μg*F/g
Change From Baseline in Fluoride Concentration at 2 Hours Post Brushing With Study Treatments
μg*F/gNaF Toothpaste(1450ppmF)NaF Toothpaste (1400ppmF)NaMFP/NaF Toothpaste (1450ppmF)Placebo Toothpaste (0ppmF)
Change From Baseline in Fluoride Concentration at 2 Hours Post Brushing With Study Treatments0.09 (-0.1 to 0.7)0.09 (-0.1 to 1.0)0.07 (-0.3 to 0.5)0.00 (-0.1 to 0.1)
Statistical analysis
  • NaF Toothpaste(1450ppmF) vs NaF Toothpaste (1400ppmF) · Wilcoxon Signed Rank Test · p = 0.0783 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): -0.04 · 95% CI -0.08 to 0.00Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste(1450ppmF) vs NaMFP/NaF Toothpaste (1450ppmF) · Wilcoxon Signed Rank Test · p = 0.0531 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): 0.03 · 95% CI 0.00 to 0.07Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste(1450ppmF) vs Placebo Toothpaste (0ppmF) · Wilcoxon Signed Rank Test · p = <0.0001 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): 0.10 · 95% CI 0.07 to 0.14Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste (1400ppmF) vs NaMFP/NaF Toothpaste (1450ppmF) · Wilcoxon Signed Rank Test · p = 0.0005 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): 0.08 · 95% CI 0.03 to 0.15Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste (1400ppmF) vs Placebo Toothpaste (0ppmF) · Wilcoxon Signed Rank Test · p = <0.0001 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): 0.12 · 95% CI 0.08 to 0.20Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaMFP/NaF Toothpaste (1450ppmF) vs Placebo Toothpaste (0ppmF) · Wilcoxon Signed Rank Test · p = <0.0001 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): 0.07 · 95% CI 0.04 to 0.10Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
SecondaryChange From Baseline in Fluoride Concentration at 4 Hours Post Brushing With Study Treatments

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.

Time frame:
Plaque samples were collected at baseline, 4 hours post single application of study treatment
Reported as:
Median · μg*F/g
Change From Baseline in Fluoride Concentration at 4 Hours Post Brushing With Study Treatments
μg*F/gNaF Toothpaste(1450ppmF)NaF Toothpaste (1400ppmF)NaMFP/NaF Toothpaste (1450ppmF)Placebo Toothpaste (0ppmF)
Change From Baseline in Fluoride Concentration at 4 Hours Post Brushing With Study Treatments0.04 (-0.1 to 0.7)0.04 (-0.1 to 1.2)0.02 (-0.3 to 0.2)-0.01 (-0.1 to 0.1)
Statistical analysis
  • NaF Toothpaste(1450ppmF) vs NaF Toothpaste (1400ppmF) · Wilcoxon Signed Rank Test · p = 0.4309 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): -0.01 · 95% CI -0.03 to 0.01Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste(1450ppmF) vs NaMFP/NaF Toothpaste (1450ppmF) · Wilcoxon Signed Rank Test · p = 0.0726 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): 0.02 · 95% CI 0.00 to 0.04Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste(1450ppmF) vs Placebo Toothpaste (0ppmF) · Wilcoxon Signed Rank Test · p = <0.0001 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): 0.04 · 95% CI 0.03 to 0.06Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste (1400ppmF) vs NaMFP/NaF Toothpaste (1450ppmF) · Wilcoxon Signed Rank Test · p = 0.0107 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): 0.03 · 95% CI 0.01 to 0.06Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste (1400ppmF) vs Placebo Toothpaste (0ppmF) · Wilcoxon Signed Rank Test · p = <0.0001 · Median difference (final values): 0.05 · 95% CI 0.03 to 0.07Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaMFP/NaF Toothpaste (1450ppmF) vs Placebo Toothpaste (0ppmF) · Wilcoxon Signed Rank Test · p = 0.0012 (No adjustments for multiple comparisons were made as the primary comparison was pre-defined.) · Median difference (final values): 0.03 · 95% CI 0.01 to 0.04Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.

Adverse events

Collected over All adverse events 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
NaF Toothpaste(1450ppmF)—0/58 (0%)0/58 (0%)
NaF Toothpaste (1400ppmF)—0/59 (0%)0/59 (0%)
NaMFP/NaF Toothpaste (1450ppmF)—0/61 (0%)0/61 (0%)
Placebo Toothpaste (0ppmF)—0/59 (0%)0/59 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Overall Study
Mean26.4 ± 6.97
Sex: Female, Male
Sex: Female, Male(Participants)Overall Study
Female31
Male34
Region of Enrollment
Region of Enrollment(participants)Overall Study
United States65
08

Study locations

1 site
  • Indiana University School of Dentistry
    Indianapolis, Indiana 46202, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00708305
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jul 2, 2008
Start date
Jun 2008
Primary completion
Oct 2008
Completion
Oct 2008
Results posted
Jun 10, 2013
Last update
Jan 1, 2015

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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