Trial Outcomes & Findings for A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model (NCT NCT01607411)

Last Updated: 2014-08-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

55 participants

Primary outcome timeframe

Baseline to 4 hours

Results posted on

2014-08-11

Participant Flow

Participants were recruited at the clinical site.

Of the 70 participants screened, 15 were not randomized into the study (12 did not meet study criteria and 3 withdrew the consent). A washout fluoride (F) toothpaste was used for a week prior treatment. In-situ appliances were prepared for participants to fit enamel specimens.

Participant milestones

Participant milestones
Measure	Sodium Fluoride(NaF) Toothpaste (1426parts Per Million(Ppm) F) Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 grams (g) ± 0.1g of NaF toothpaste(1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided	NaF Toothpaste (1000 Ppm F) Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided	NaF Toothpaste (500 Ppm F) Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided	Placebo Toothpaste (0 Ppm F) Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
Period I STARTED	14	13	14	14
Period I COMPLETED	14	13	14	14
Period I NOT COMPLETED	0	0	0	0
Period II STARTED	14	14	13	14
Period II COMPLETED	14	14	13	14
Period II NOT COMPLETED	0	0	0	0
Period III STARTED	14	14	14	13
Period III COMPLETED	14	14	14	13
Period III NOT COMPLETED	0	0	0	0
Period IV STARTED	13	14	14	14
Period IV COMPLETED	13	14	14	14
Period IV NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=55 Participants All randomized participants who received atleast one dose of the study treatments
Age, Continuous	12.4 Years STANDARD_DEVIATION 1.12 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	9 Participants n=5 Participants
Race/Ethnicity, Customized White	41 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 4 hours

Population: Per Protocol (PP) Population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing enamel specimen values were imputed, by averaging over the available enamel specimens.

Outcome measures

Outcome measures
Measure	NaF Toothpaste (1426 Ppm F) n=55 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided	NaF Toothpaste (1000 Ppm F) n=55 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided	NaF Toothpaste (500 Ppm F) n=55 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided	Placebo Toothpaste (0 Ppm F) n=55 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice	30.72 %SMHR Standard Error 0.87	29.49 %SMHR Standard Error 0.87	28.29 %SMHR Standard Error 0.87	25.13 %SMHR Standard Error 0.87

SECONDARY outcome

Timeframe: Baseline to 4 hours

Outcome measures

Outcome measures
Measure	NaF Toothpaste (1426 Ppm F) n=55 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided	NaF Toothpaste (1000 Ppm F) n=55 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided	NaF Toothpaste (500 Ppm F) n=55 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided	Placebo Toothpaste (0 Ppm F) Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
%SMHR of Enamel Specimens Exposed to Test Treatments	30.72 %SMHR Standard Error 0.87	29.49 %SMHR Standard Error 0.87	28.29 %SMHR Standard Error 0.87	—

SECONDARY outcome

Timeframe: Baseline to 4 hours

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.

Outcome measures

Outcome measures
Measure	NaF Toothpaste (1426 Ppm F) n=55 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided	NaF Toothpaste (1000 Ppm F) n=55 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided	NaF Toothpaste (500 Ppm F) n=55 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided	Placebo Toothpaste (0 Ppm F) n=55 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
Percent Net Acid Resistance (%NAR) of Enamel Specimens	-19.72 %NAR Standard Error 1.90	-19.52 %NAR Standard Error 1.90	-25.82 %NAR Standard Error 1.90	-54.38 %NAR Standard Error 1.90

SECONDARY outcome

Timeframe: Baseline to 4 hours

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.

Outcome measures

Outcome measures
Measure	NaF Toothpaste (1426 Ppm F) n=55 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided	NaF Toothpaste (1000 Ppm F) n=55 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided	NaF Toothpaste (500 Ppm F) n=55 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided	Placebo Toothpaste (0 Ppm F) n=55 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
Enamel Fluoride Uptake	1.76 μg*F/cm^2 Standard Error 0.08	1.77 μg*F/cm^2 Standard Error 0.08	1.47 μg*F/cm^2 Standard Error 0.08	0.98 μg*F/cm^2 Standard Error 0.08

Adverse Events

NaF Toothpaste (1426 Ppm F)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

NaF Toothpaste (1000 Ppm F)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

NaF Toothpaste (500 Ppm F)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo Toothpaste (0 Ppm F)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	NaF Toothpaste (1426 Ppm F) n=55 participants at risk Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided	NaF Toothpaste (1000 Ppm F) n=55 participants at risk Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided	NaF Toothpaste (500 Ppm F) n=55 participants at risk Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided	Placebo Toothpaste (0 Ppm F) n=55 participants at risk Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
Nervous system disorders Headache	1.8% 1/55 • Number of events 1 • Baseline through 5 days post administration of last treatment	3.6% 2/55 • Number of events 2 • Baseline through 5 days post administration of last treatment	3.6% 2/55 • Number of events 2 • Baseline through 5 days post administration of last treatment	0.00% 0/55 • Baseline through 5 days post administration of last treatment
Skin and subcutaneous tissue disorders Lip injury	3.6% 2/55 • Number of events 2 • Baseline through 5 days post administration of last treatment	0.00% 0/55 • Baseline through 5 days post administration of last treatment	0.00% 0/55 • Baseline through 5 days post administration of last treatment	1.8% 1/55 • Number of events 1 • Baseline through 5 days post administration of last treatment
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	0.00% 0/55 • Baseline through 5 days post administration of last treatment	0.00% 0/55 • Baseline through 5 days post administration of last treatment	3.6% 2/55 • Number of events 2 • Baseline through 5 days post administration of last treatment	1.8% 1/55 • Number of events 1 • Baseline through 5 days post administration of last treatment
Ear and labyrinth disorders Sinusitis	0.00% 0/55 • Baseline through 5 days post administration of last treatment	1.8% 1/55 • Number of events 1 • Baseline through 5 days post administration of last treatment	1.8% 1/55 • Number of events 1 • Baseline through 5 days post administration of last treatment	0.00% 0/55 • Baseline through 5 days post administration of last treatment
Respiratory, thoracic and mediastinal disorders Pharyngitis streptococcal	0.00% 0/55 • Baseline through 5 days post administration of last treatment	1.8% 1/55 • Number of events 1 • Baseline through 5 days post administration of last treatment	1.8% 1/55 • Number of events 1 • Baseline through 5 days post administration of last treatment	0.00% 0/55 • Baseline through 5 days post administration of last treatment
Gastrointestinal disorders Oral herpes	0.00% 0/55 • Baseline through 5 days post administration of last treatment	0.00% 0/55 • Baseline through 5 days post administration of last treatment	1.8% 1/55 • Number of events 1 • Baseline through 5 days post administration of last treatment	1.8% 1/55 • Number of events 1 • Baseline through 5 days post administration of last treatment
Ear and labyrinth disorders Ear infection	1.8% 1/55 • Number of events 1 • Baseline through 5 days post administration of last treatment	0.00% 0/55 • Baseline through 5 days post administration of last treatment	0.00% 0/55 • Baseline through 5 days post administration of last treatment	0.00% 0/55 • Baseline through 5 days post administration of last treatment
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/55 • Baseline through 5 days post administration of last treatment	1.8% 1/55 • Number of events 1 • Baseline through 5 days post administration of last treatment	0.00% 0/55 • Baseline through 5 days post administration of last treatment	0.00% 0/55 • Baseline through 5 days post administration of last treatment
Skin and subcutaneous tissue disorders Rash	0.00% 0/55 • Baseline through 5 days post administration of last treatment	1.8% 1/55 • Number of events 1 • Baseline through 5 days post administration of last treatment	0.00% 0/55 • Baseline through 5 days post administration of last treatment	0.00% 0/55 • Baseline through 5 days post administration of last treatment
Skin and subcutaneous tissue disorders Chapped lips	0.00% 0/55 • Baseline through 5 days post administration of last treatment	0.00% 0/55 • Baseline through 5 days post administration of last treatment	0.00% 0/55 • Baseline through 5 days post administration of last treatment	1.8% 1/55 • Number of events 1 • Baseline through 5 days post administration of last treatment
Musculoskeletal and connective tissue disorders Gingival erythema	0.00% 0/55 • Baseline through 5 days post administration of last treatment	0.00% 0/55 • Baseline through 5 days post administration of last treatment	0.00% 0/55 • Baseline through 5 days post administration of last treatment	1.8% 1/55 • Number of events 1 • Baseline through 5 days post administration of last treatment
Renal and urinary disorders Blood urine present	0.00% 0/55 • Baseline through 5 days post administration of last treatment	0.00% 0/55 • Baseline through 5 days post administration of last treatment	0.00% 0/55 • Baseline through 5 days post administration of last treatment	1.8% 1/55 • Number of events 1 • Baseline through 5 days post administration of last treatment

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