CompletedNCT01607411Updated Aug 11, 2014Results posted

A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model

A Phase 3 interventional study of Fluoride and Placebo in Dental Caries, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 11 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-11.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 55
Allocation: Randomized
Ages: 11 Years to 14 Years
Sex: All

Study summary

An in situ model will be used to evaluate and compare enamel remineralization of human enamel specimens after single use of experimental children's toothpastes.

Conditions studied

Dental Caries

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Dental Caries 1,110

In context

Dental Caries

1,110 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's enrollment of 55 is close to the median of 60 across 917 interventional studies indexed under Dental Caries.

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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.

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

Who can participate

Ages eligible: 11 Years to 14 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy males and females aged 11 to 14 inclusive who have an unstimulated salivary flow rate of at least 0.2 mL/minute and a stimulated salivary flow rate of at least 0.8 mL/minute (Screening Visit 1).

Exclusion criteria

Exclusion Criteria:

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Single (Investigator)
Enrollment: 55 participants (actual)

Study arms

Placebo comparator
Fluoride free toothpaste
toothpaste with no fluoride
Drug: Placebo
Experimental
1426ppm Fluoride Toothpaste
Experimental toothpaste containing 1426 ppm Fluoride
Drug: Fluoride
Experimental
1000 ppm Fluoride Toothpaste
Experimental toothpaste containing 1000 ppm Fluoride
Drug: Fluoride
Experimental
500 ppm Toothpaste
Experimental toothpaste containing 500 ppm Fluoride
Drug: Fluoride

Interventions

DrugFluoride
Fluoride Toothpaste
DrugPlacebo
Fluoride free toothpaste

What researchers measure

Primary outcomes

Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice
Surface microhardness recovery (SMHR) test was used to assess the changes in 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. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: \[(D1-R)/ (D1-B)\]\*100.
Time frame: Baseline to 4 hours

Secondary outcomes

%SMHR of Enamel Specimens Exposed to Test Treatments
Surface microhardness recovery (SMHR) test was used to assess the changes in 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. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: \[(D1-R)/ (D1-B)\]\*100.
Time frame: Baseline to 4 hours
Percent Net Acid Resistance (%NAR) of Enamel Specimens
Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NAR which compared the indentations values of sound enamel specimens at baseline (B), first demineralization challenge (D1) and second demineralization challenge (D2). Percent NAR was calculated by formula: \[(D1-D2)/ (D1-B)\]\*100.
Time frame: Baseline to 4 hours
Enamel Fluoride Uptake
Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of F divided by volume of the enamel cores and expressed as micrograms (μg)\* F/centimeters(cm)\^2. Difference between treatments was calculated with respect to F uptake by enamel.
Time frame: Baseline to 4 hours

Results

Posted Aug 26, 2013

Participant flow

Participants were recruited at the clinical site.

Period I

Participant flow — Period I
Milestone	Sodium Fluoride(NaF) Toothpaste (1426parts Per Million(Ppm) F)	NaF Toothpaste (1000 Ppm F)	NaF Toothpaste (500 Ppm F)	Placebo Toothpaste (0 Ppm F)
Started	14	13	14	14
Completed	14	13	14	14
Not completed	0	0	0	0

Period II

Participant flow — Period II
Milestone	Sodium Fluoride(NaF) Toothpaste (1426parts Per Million(Ppm) F)	NaF Toothpaste (1000 Ppm F)	NaF Toothpaste (500 Ppm F)	Placebo Toothpaste (0 Ppm F)
Started	14	14	13	14
Completed	14	14	13	14
Not completed	0	0	0	0

Period III

Participant flow — Period III
Milestone	Sodium Fluoride(NaF) Toothpaste (1426parts Per Million(Ppm) F)	NaF Toothpaste (1000 Ppm F)	NaF Toothpaste (500 Ppm F)	Placebo Toothpaste (0 Ppm F)
Started	14	14	14	13
Completed	14	14	14	13
Not completed	0	0	0	0

Period IV

Participant flow — Period IV
Milestone	Sodium Fluoride(NaF) Toothpaste (1426parts Per Million(Ppm) F)	NaF Toothpaste (1000 Ppm F)	NaF Toothpaste (500 Ppm F)	Placebo Toothpaste (0 Ppm F)
Started	13	14	14	14
Completed	13	14	14	14
Not completed	0	0	0	0

Outcome measures

PrimaryPercentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice

Surface microhardness recovery (SMHR) test was used to assess the changes in 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. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: \[(D1-R)/ (D1-B)\]\*100.

Time frame:: Baseline to 4 hours
Reported as:: Mean · %SMHR

Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice
%SMHR	NaF Toothpaste (1426 Ppm F)	NaF Toothpaste (1000 Ppm F)	NaF Toothpaste (500 Ppm F)	Placebo Toothpaste (0 Ppm F)
Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice	30.72 ± 0.87	29.49 ± 0.87	28.29 ± 0.87	25.13 ± 0.87

Statistical analysis

NaF Toothpaste (1426 Ppm F) vs Placebo Toothpaste (0 Ppm F) · ANOVA · p = <0.0001 (No adjustment was required for multiple comparisons as the primary comparison was pre-specified.) · Adjusted mean difference: 5.59 · 95% CI 3.60 to 7.58Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
NaF Toothpaste (1000 Ppm F) vs Placebo Toothpaste (0 Ppm F) · ANOVA · p = <0.0001 (No adjustment was required for multiple comparisons as the primary comparison was pre-specified) · Adjusted mean difference: 4.36 · 95% CI 2.37 to 6.35Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
NaF Toothpaste (500 Ppm F) vs Placebo Toothpaste (0 Ppm F) · ANOVA · p = 0.0021 (No adjustment was required for multiple comparisons as the primary comparison was pre-specified) · Adjusted mean difference: 3.16 · 95% CI 1.17 to 5.15Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment

Secondary%SMHR of Enamel Specimens Exposed to Test Treatments

Time frame:: Baseline to 4 hours
Reported as:: Mean · %SMHR

%SMHR of Enamel Specimens Exposed to Test Treatments
%SMHR	NaF Toothpaste (1426 Ppm F)	NaF Toothpaste (1000 Ppm F)	NaF Toothpaste (500 Ppm F)
%SMHR of Enamel Specimens Exposed to Test Treatments	30.72 ± 0.87	29.49 ± 0.87	28.29 ± 0.87

Statistical analysis

NaF Toothpaste (1426 Ppm F) vs NaF Toothpaste (1000 Ppm F) · ANOVA · p = 0.2225 (No adjustment was required for multiple comparisons as the primary comparison was pre-specified) · Adjusted mean difference: 1.23 · 95% CI -0.76 to 3.22Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
NaF Toothpaste (1426 Ppm F) vs NaF Toothpaste (500 Ppm F) · ANOVA · p = 0.0168 (No adjustment was required for multiple comparisons as the primary comparison was pre-specified) · Adjusted mean difference: 2.44 · 95% CI 0.44 to 4.43Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
NaF Toothpaste (1000 Ppm F) vs NaF Toothpaste (500 Ppm F) · ANOVA · p = 0.2352 (No adjustment was required for multiple comparisons as the primary comparison was pre-specified) · Adjusted mean difference: 1.20 · 95% CI -0.79 to 3.19Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment

SecondaryPercent Net Acid Resistance (%NAR) of Enamel Specimens

Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NAR which compared the indentations values of sound enamel specimens at baseline (B), first demineralization challenge (D1) and second demineralization challenge (D2). Percent NAR was calculated by formula: \[(D1-D2)/ (D1-B)\]\*100.

Time frame:: Baseline to 4 hours
Reported as:: Mean · %NAR

Percent Net Acid Resistance (%NAR) of Enamel Specimens
%NAR	NaF Toothpaste (1426 Ppm F)	NaF Toothpaste (1000 Ppm F)	NaF Toothpaste (500 Ppm F)	Placebo Toothpaste (0 Ppm F)
Percent Net Acid Resistance (%NAR) of Enamel Specimens	-19.72 ± 1.90	-19.52 ± 1.90	-25.82 ± 1.90	-54.38 ± 1.90

Statistical analysis

NaF Toothpaste (1426 Ppm F) vs Placebo Toothpaste (0 Ppm F) · ANOVA · p = <0.0001 (No adjustment was required for multiple comparisons as the primary comparison was pre-specified) · Adjusted mean difference: 34.65 · 95% CI 30.07 to 39.24Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
NaF Toothpaste (1000 Ppm F) vs Placebo Toothpaste (0 Ppm F) · ANOVA · p = <0.0001 (No adjustment was required for multiple comparisons as the primary comparison was pre-specified) · Adjusted mean difference: 34.86 · 95% CI 30.28 to 39.44Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
NaF Toothpaste (500 Ppm F) vs Placebo Toothpaste (0 Ppm F) · ANOVA · p = < 0.0001 (No adjustment was required for multiple comparisons as the primary comparison was pre-specified) · Adjusted mean difference: 28.55 · 95% CI 23.97 to 33.13Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
NaF Toothpaste (1426 Ppm F) vs NaF Toothpaste (1000 Ppm F) · ANOVA · p = 0.9292 (No adjustment was required for multiple comparisons as the primary comparison was pre-specified) · Adjusted mean difference: -0.21 · 95% CI -4.79 to 4.38Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
NaF Toothpaste (1426 Ppm F) vs NaF Toothpaste (500 Ppm F) · ANOVA · p = 0.0094 (No adjustment was required for multiple comparisons as the primary comparison was pre-specified) · Adjusted mean difference: 6.10 · 95% CI 1.52 to 10.69Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
NaF Toothpaste (1000 Ppm F) vs NaF Toothpaste (500 Ppm F) · ANOVA · p = 0.0073 (No adjustment was required for multiple comparisons as the primary comparison was pre-specified) · Adjusted mean difference: 6.31 · 95% CI 1.72 to 10.89Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment

SecondaryEnamel Fluoride Uptake

Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of F divided by volume of the enamel cores and expressed as micrograms (μg)\* F/centimeters(cm)\^2. Difference between treatments was calculated with respect to F uptake by enamel.

Time frame:: Baseline to 4 hours
Reported as:: Mean · μg*F/cm^2

Enamel Fluoride Uptake
μg*F/cm^2	NaF Toothpaste (1426 Ppm F)	NaF Toothpaste (1000 Ppm F)	NaF Toothpaste (500 Ppm F)	Placebo Toothpaste (0 Ppm F)
Enamel Fluoride Uptake	1.76 ± 0.08	1.77 ± 0.08	1.47 ± 0.08	0.98 ± 0.08

Statistical analysis

NaF Toothpaste (1426 Ppm F) vs Placebo Toothpaste (0 Ppm F) · ANOVA · p = <0.0001 (No adjustment was required for multiple comparisons as the primary comparison was pre-specified) · Adjusted mean difference: 0.78 · 95% CI 0.58 to 0.98Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
NaF Toothpaste (1000 Ppm F) vs Placebo Toothpaste (0 Ppm F) · ANOVA · p = <0.0001 (No adjustment was required for multiple comparisons as the primary comparison was pre-specified) · Adjusted mean difference: 0.79 · 95% CI 0.58 to 0.99Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
NaF Toothpaste (500 Ppm F) vs Placebo Toothpaste (0 Ppm F) · ANOVA · p = < 0.0001 (No adjustment was required for multiple comparisons as the primary comparison was pre-specified) · Adjusted mean difference: 0.49 · 95% CI 0.29 to 0.69Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
NaF Toothpaste (1426 Ppm F) vs NaF Toothpaste (1000 Ppm F) · ANOVA · p = 0.9631 (No adjustment was required for multiple comparisons as the primary comparison was pre-specified) · Adjusted mean difference: -0.005 · 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
NaF Toothpaste (1426 Ppm F) vs NaF Toothpaste (500 Ppm F) · ANOVA · p = 0.0047 (No adjustment was required for multiple comparisons as the primary comparison was pre-specified) · Adjusted mean difference: 0.29 · 95% CI 0.09 to 0.49Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
NaF Toothpaste (1000 Ppm F) vs NaF Toothpaste (500 Ppm F) · ANOVA · p = 0.0040 (No adjustment was required for multiple comparisons as the primary comparison was pre-specified) · Adjusted mean difference: 0.30 · 95% CI 0.10 to 0.50Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment

Adverse events

Collected over Baseline through 5 days post administration of last treatment. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
NaF Toothpaste (1426 Ppm F)	—	0/55 (0%)	4/55 (7.3%)
NaF Toothpaste (1000 Ppm F)	—	0/55 (0%)	6/55 (10.9%)
NaF Toothpaste (500 Ppm F)	—	0/55 (0%)	7/55 (12.7%)
Placebo Toothpaste (0 Ppm F)	—	0/55 (0%)	6/55 (10.9%)

Most frequent other events

Showing 10 of 12

Most frequent other events
Event	NaF Toothpaste (1426 Ppm F)	NaF Toothpaste (1000 Ppm F)	NaF Toothpaste (500 Ppm F)	Placebo Toothpaste (0 Ppm F)
HeadacheNervous system disorders	1/55	2/55	2/55	0/55
Lip injurySkin and subcutaneous tissue disorders	2/55	0/55	0/55	1/55
NasopharyngitisRespiratory, thoracic and mediastinal disorders	0/55	0/55	2/55	1/55
SinusitisEar and labyrinth disorders	0/55	1/55	1/55	0/55
Pharyngitis streptococcalRespiratory, thoracic and mediastinal disorders	0/55	1/55	1/55	0/55
Oral herpesGastrointestinal disorders	0/55	0/55	1/55	1/55
Ear infectionEar and labyrinth disorders	1/55	0/55	0/55	0/55
MyalgiaMusculoskeletal and connective tissue disorders	0/55	1/55	0/55	0/55
RashSkin and subcutaneous tissue disorders	0/55	1/55	0/55	0/55
Chapped lipsSkin and subcutaneous tissue disorders	0/55	0/55	0/55	1/55

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	Overall
Mean	12.4 ± 1.12

Sex: Female, Male
Sex: Female, Male(Participants)	Overall
Female	31
Male	24

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Overall
Black or African American	9
White	41
More than one race	5

Study locations

1 site

Indiana University School of Dentistry
Indianapolis, Indiana 46202, United States

References and documents

Publications

Newby EE, Martinez-Mier EA, Hara A, Lippert F, Kelly SA, Fleming N, Butler A, Bosma ML, Zero DT. A randomised clinical study to evaluate experimental children's toothpastes in an in-situ palatal caries model in children aged 11-14 years. Int Dent J. 2013 Dec;63 Suppl 2(Suppl 2):31-8. doi: 10.1111/idj.12073. PubMed 24283282 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01607411
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: May 30, 2012
Start date: Feb 2012
Primary completion: May 2012
Completion: May 2012
Results posted: Aug 26, 2013
Last update: Aug 11, 2014

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model

Study summary

Conditions studied

Browse trials for

In context

Dental Caries

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria