Trial Outcomes & Findings for Evaluation of the Fluoride Dose Response Using In Situ Caries Model (NCT NCT04763044)

Last Updated: 2022-07-19

Results Overview

The EFU test will evaluate the level of fluoride in partially demineralized enamel specimens via the microdrill enamel biopsy technique by \[Sakkab et al., 1984\]. The calculated scores will be measured in μg F/cm2.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

15 participants

Primary outcome timeframe

Evaluations will occur after 21 days of product use

Results posted on

2022-07-19

Participant Flow

Participant milestones

Participant milestones
Measure	0 Ppm MFP, 250 Ppm MFP, 1100 Ppm MFP, 2800 Ppm MFP, 1100 Ppm SnF2 This was a 4-way crossover design study. All participants were randomized to receive the following interventions in this order: 0, 250, 1100 and 2800 ppm fluoride as sodium monofluorophosphate (MFP) using an in situ caries model. Participants were additionally invited to participate in a fifth leg which contained 1100 ppm SnF2.	250 Ppm MFP, 2800 Ppm MFP, 0 Ppm MFP, 1100 Ppm MFP, 1100 Ppm SnF2 This was a 4-way crossover design study. All participants were randomized to receive the following interventions in this order: 250, 2800, 0, and 1100 ppm fluoride as sodium monofluorophosphate (MFP) using an in situ caries model. Participants were additionally invited to participate in a fifth leg which contained 1100 ppm SnF2.	1100 Ppm MFP, 0 Ppm MFP, 2800 Ppm MFP, 250 Ppm MFP, 1100 Ppm SnF2 This was a 4-way crossover design study. All participants were randomized to receive the following interventions in this order: 1100, 0, 2800 and 250 ppm fluoride as sodium monofluorophosphate (MFP) using an in situ caries model. Participants were additionally invited to participate in a fifth leg which contained 1100 ppm SnF2.	2800 Ppm MFP, 1100 Ppm MFP, 250 Ppm MFP, 0 Ppm MFP, 1100 Ppm SnF2 This was a 4-way crossover design study. All participants were randomized to receive the following interventions in this order: 2800, 1100, 250 and 0 ppm fluoride as sodium monofluorophosphate (MFP) using an in situ caries model. Participants were additionally invited to participate in a fifth leg which contained 1100 ppm SnF2.
Period 1 STARTED	3	4	4	4
Period 1 COMPLETED	3	4	4	3
Period 1 NOT COMPLETED	0	0	0	1
Period 2 STARTED	3	4	4	3
Period 2 COMPLETED	3	4	4	3
Period 2 NOT COMPLETED	0	0	0	0
Period 3 STARTED	3	4	4	3
Period 3 COMPLETED	3	4	4	3
Period 3 NOT COMPLETED	0	0	0	0
Period 4 STARTED	3	3	4	3
Period 4 COMPLETED	3	3	4	3
Period 4 NOT COMPLETED	0	0	0	0
Period 5 STARTED	3	3	4	3
Period 5 COMPLETED	2	3	4	3
Period 5 NOT COMPLETED	1	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0 Ppm MFP, 250 Ppm MFP, 1100 Ppm MFP, 2800 Ppm MFP, 1100 Ppm SnF2 n=3 Participants This was a 4-way crossover design study. All participants were randomized to receive the following interventions in this order: 0, 250, 1100 and 2800 ppm fluoride as sodium monofluorophosphate (MFP) using an in situ caries model. Participants were additionally invited to participate in a fifth leg which contained 1100 ppm SnF2.	250 Ppm MFP, 2800 Ppm MFP, 0 Ppm MFP, 1100 Ppm MFP, 1100 Ppm SnF2 n=4 Participants This was a 4-way crossover design study. All participants were randomized to receive the following interventions in this order: 250, 2800, 0 and 1100 ppm fluoride as sodium monofluorophosphate (MFP) using an in situ caries model. Participants were additionally invited to participate in a fifth leg which contained 1100 ppm SnF2.	1100 Ppm MFP, 0 Ppm MFP, 2800 Ppm MFP, 250 Ppm MFP, 1100 Ppm SnF2 n=4 Participants This was a 4-way crossover design study. All participants were randomized to receive the following interventions in this order: 1100, 0, 2800 and 250 ppm fluoride as sodium monofluorophosphate (MFP) using an in situ caries model. Participants were additionally invited to participate in a fifth leg which contained 1100 ppm SnF2.	2800 Ppm MFP, 1100 Ppm MFP, 250 Ppm MFP, 0 Ppm MFP, 1100 Ppm SnF2 n=4 Participants This was a 4-way crossover design study. All participants were randomized to receive the following interventions in this order: 2800, 1100, 250 and 0 ppm fluoride as sodium monofluorophosphate (MFP) using an in situ caries model. Participants were additionally invited to participate in a fifth leg which contained 1100 ppm SnF2.	Total n=15 Participants Total of all reporting groups
Age, Continuous	69.7 years STANDARD_DEVIATION 8.33 • n=3 Participants	72.5 years STANDARD_DEVIATION 4.51 • n=4 Participants	69.7 years STANDARD_DEVIATION 9.50 • n=4 Participants	76.3 years STANDARD_DEVIATION 9.32 • n=4 Participants	72.2 years STANDARD_DEVIATION 7.75 • n=15 Participants
Sex: Female, Male Female	1 Participants n=3 Participants	2 Participants n=4 Participants	4 Participants n=4 Participants	2 Participants n=4 Participants	9 Participants n=15 Participants
Sex: Female, Male Male	2 Participants n=3 Participants	2 Participants n=4 Participants	0 Participants n=4 Participants	2 Participants n=4 Participants	6 Participants n=15 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=15 Participants
Race (NIH/OMB) Asian	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=15 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=15 Participants
Race (NIH/OMB) Black or African American	0 Participants n=3 Participants	2 Participants n=4 Participants	3 Participants n=4 Participants	4 Participants n=4 Participants	9 Participants n=15 Participants
Race (NIH/OMB) White	2 Participants n=3 Participants	2 Participants n=4 Participants	1 Participants n=4 Participants	0 Participants n=4 Participants	5 Participants n=15 Participants
Race (NIH/OMB) More than one race	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=15 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	1 Participants n=15 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	3 participants n=3 Participants	4 participants n=4 Participants	4 participants n=4 Participants	4 participants n=4 Participants	15 participants n=15 Participants

PRIMARY outcome

Timeframe: Evaluations will occur after 21 days of product use

Outcome measures

Outcome measures
Measure	0 Ppm F (Placebo, Negative Control) n=14 Participants Each subject was randomly assigned to 0 ppm F dentifrice during one of the four periods for this crossover study.	250 Ppm F as MFP (Dose-response Control) n=14 Participants Each subject was randomly assigned to 250 ppm F dentifrice during one of the four periods for this crossover study.	1100 Ppm F as MFP (Reference) n=13 Participants Each subject was randomly assigned to 1100 ppm F dentifrice during one of the four periods for this crossover study.	2800 Ppm F as MFP (Dose-response Control) n=14 Participants Each subject was randomly assigned to 2800 ppm F dentifrice during one of the four periods for this crossover study.	1100 Ppm SnF2 n=12 Participants Each subject was assigned to 1100 ppm SnF2 dentifrice during the fifth period for this study.
Enamel Fluoride Uptake (EFU)	2.28 μg F/cm^2 Standard Error 0.709	4.51 μg F/cm^2 Standard Error 0.709	8.78 μg F/cm^2 Standard Error 0.736	14.05 μg F/cm^2 Standard Error 0.709	7.43 μg F/cm^2 Standard Error 0.423

SECONDARY outcome

Timeframe: Evaluations will occur after 7 days of product use

Outcome measures

Outcome measures
Measure	0 Ppm F (Placebo, Negative Control) n=14 Participants Each subject was randomly assigned to 0 ppm F dentifrice during one of the four periods for this crossover study.	250 Ppm F as MFP (Dose-response Control) n=14 Participants Each subject was randomly assigned to 250 ppm F dentifrice during one of the four periods for this crossover study.	1100 Ppm F as MFP (Reference) n=13 Participants Each subject was randomly assigned to 1100 ppm F dentifrice during one of the four periods for this crossover study.	2800 Ppm F as MFP (Dose-response Control) n=14 Participants Each subject was randomly assigned to 2800 ppm F dentifrice during one of the four periods for this crossover study.	1100 Ppm SnF2 n=13 Participants Each subject was assigned to 1100 ppm SnF2 dentifrice during the fifth period for this study.
Enamel Fluoride Uptake (EFU)	3.13 μg F/cm^2 Standard Error 0.881	5.20 μg F/cm^2 Standard Error 0.882	8.20 μg F/cm^2 Standard Error 0.916	13.52 μg F/cm^2 Standard Error 0.850	9.11 μg F/cm^2 Standard Error 0.670

SECONDARY outcome

Timeframe: Evaluations will occur after 7 days of product use

The SMH test will evaluate changes in the mineral status of partially demineralized enamel specimens through use of a Wilson 2100 Hardness Tester. These scores will be calculated as a percent.

Outcome measures

Outcome measures
Measure	0 Ppm F (Placebo, Negative Control) n=14 Participants Each subject was randomly assigned to 0 ppm F dentifrice during one of the four periods for this crossover study.	250 Ppm F as MFP (Dose-response Control) n=14 Participants Each subject was randomly assigned to 250 ppm F dentifrice during one of the four periods for this crossover study.	1100 Ppm F as MFP (Reference) n=13 Participants Each subject was randomly assigned to 1100 ppm F dentifrice during one of the four periods for this crossover study.	2800 Ppm F as MFP (Dose-response Control) n=14 Participants Each subject was randomly assigned to 2800 ppm F dentifrice during one of the four periods for this crossover study.	1100 Ppm SnF2 n=13 Participants Each subject was assigned to 1100 ppm SnF2 dentifrice during the fifth period for this study.
Percent Surface Microhardness (SMH)	15.92 Percent SMH Recovery Standard Error 3.259	22.50 Percent SMH Recovery Standard Error 3.264	22.42 Percent SMH Recovery Standard Error 3.360	35.61 Percent SMH Recovery Standard Error 3.160	26.32 Percent SMH Recovery Standard Error 4.605

SECONDARY outcome

Timeframe: Evaluations will occur after 14 days of product use

Outcome measures

Outcome measures
Measure	0 Ppm F (Placebo, Negative Control) n=14 Participants Each subject was randomly assigned to 0 ppm F dentifrice during one of the four periods for this crossover study.	250 Ppm F as MFP (Dose-response Control) n=14 Participants Each subject was randomly assigned to 250 ppm F dentifrice during one of the four periods for this crossover study.	1100 Ppm F as MFP (Reference) n=13 Participants Each subject was randomly assigned to 1100 ppm F dentifrice during one of the four periods for this crossover study.	2800 Ppm F as MFP (Dose-response Control) n=14 Participants Each subject was randomly assigned to 2800 ppm F dentifrice during one of the four periods for this crossover study.	1100 Ppm SnF2 n=13 Participants Each subject was assigned to 1100 ppm SnF2 dentifrice during the fifth period for this study.
Enamel Fluoride Uptake (EFU)	3.86 μg F/cm^2 Standard Error 1.141	7.23 μg F/cm^2 Standard Error 1.141	11.53 μg F/cm^2 Standard Error 1.185	18.92 μg F/cm^2 Standard Error 1.141	12.65 μg F/cm^2 Standard Error 1.215

SECONDARY outcome

Timeframe: Evaluations will occur after 14 days of product use

The SMH test will evaluate changes in the mineral status of partially demineralized enamel specimens through use of a Wilson 2100 Hardness Tester. These scores will be calculated as a percent.

Outcome measures

Outcome measures
Measure	0 Ppm F (Placebo, Negative Control) n=14 Participants Each subject was randomly assigned to 0 ppm F dentifrice during one of the four periods for this crossover study.	250 Ppm F as MFP (Dose-response Control) n=14 Participants Each subject was randomly assigned to 250 ppm F dentifrice during one of the four periods for this crossover study.	1100 Ppm F as MFP (Reference) n=13 Participants Each subject was randomly assigned to 1100 ppm F dentifrice during one of the four periods for this crossover study.	2800 Ppm F as MFP (Dose-response Control) n=14 Participants Each subject was randomly assigned to 2800 ppm F dentifrice during one of the four periods for this crossover study.	1100 Ppm SnF2 n=13 Participants Each subject was assigned to 1100 ppm SnF2 dentifrice during the fifth period for this study.
Percent Surface Microhardness (SMH)	10.49 Percent SMH Recovery Standard Error 4.258	18.62 Percent SMH Recovery Standard Error 4.258	24.76 Percent SMH Recovery Standard Error 4.369	38.08 Percent SMH Recovery Standard Error 4.258	28.28 Percent SMH Recovery Standard Error 4.562

SECONDARY outcome

Timeframe: Evaluations will occur after 21 days of product use

The SMH test will evaluate changes in the mineral status of partially demineralized enamel specimens through use of a Wilson 2100 Hardness Tester. These scores will be calculated as a percent.