Trial Outcomes & Findings for In Situ Caries Model of Fluoride Toothpastes (NCT NCT01005966)

Last Updated: 2013-07-29

Results Overview

SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH 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. Difference in percent SMH recovery was calculated by comparing study NaF toothpaste (1426ppmF) with reference AmF toothpaste (1400ppmF).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

65 participants

Primary outcome timeframe

Baseline to 14 days

Results posted on

2013-07-29

Participant Flow

Participants were recruited at the clinical site.

83 participants were screened and 18 participants did not meet the study criteria thus 65 participants were enrolled into the study. The subjects were randomized to receive all 5 study treatments in a pre-determined computerized randomised order as per a typical cross-over design.

Participant milestones

Participant milestones
Measure	Sodium Fluoride(NaF) Toothpaste[1426parts Per Million(Ppm)F] Study toothpaste containing sodium fluoride/ silica (1426ppm fluoride as NaF)	Amine Fluoride(AmF) Toothpaste (1400ppmF) Reference toothpaste containing amine fluoride (1400ppm fluoride as AmF)	Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF) Reference toothpaste containing sodium monofluorophosphate and sodium fluoride (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF)	NaF Toothpaste (675ppmF) Study toothpaste containing sodium fluoride and silica (675ppmF as NaF)	Placebo Toothpaste (0ppmF) Placebo fluoride free toothpaste
Treatment Period 1 (14 Days) STARTED	13	13	13	13	13
Treatment Period 1 (14 Days) COMPLETED	11	13	12	13	13
Treatment Period 1 (14 Days) NOT COMPLETED	2	0	1	0	0
Washout Period 1 (4 Days) STARTED	11	13	12	13	13
Washout Period 1 (4 Days) COMPLETED	11	13	12	12	13
Washout Period 1 (4 Days) NOT COMPLETED	0	0	0	1	0
Treatment Period 2 (14 Days) STARTED	13	13	12	12	11
Treatment Period 2 (14 Days) COMPLETED	13	12	10	11	11
Treatment Period 2 (14 Days) NOT COMPLETED	0	1	2	1	0
Washout Period 2 (4 Days) STARTED	13	12	10	11	11
Washout Period 2 (4 Days) COMPLETED	13	12	10	11	11
Washout Period 2 (4 Days) NOT COMPLETED	0	0	0	0	0
Treatment Period 3 (14 Days) STARTED	12	8	12	13	12
Treatment Period 3 (14 Days) COMPLETED	12	7	12	13	11
Treatment Period 3 (14 Days) NOT COMPLETED	0	1	0	0	1
Washout Period 3 ( 4 Days) STARTED	12	7	12	13	11
Washout Period 3 ( 4 Days) COMPLETED	12	7	12	13	11
Washout Period 3 ( 4 Days) NOT COMPLETED	0	0	0	0	0
Treatment Period 4 (14 Days) STARTED	10	11	11	10	13
Treatment Period 4 (14 Days) COMPLETED	10	10	11	10	12
Treatment Period 4 (14 Days) NOT COMPLETED	0	1	0	0	1
Washout Period 4 (4 Days) STARTED	10	10	11	10	12
Washout Period 4 (4 Days) COMPLETED	10	10	11	10	12
Washout Period 4 (4 Days) NOT COMPLETED	0	0	0	0	0
Treatment Period 5 (14 Days) STARTED	9	12	11	11	10
Treatment Period 5 (14 Days) COMPLETED	9	12	11	11	10
Treatment Period 5 (14 Days) NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Sodium Fluoride(NaF) Toothpaste[1426parts Per Million(Ppm)F] Study toothpaste containing sodium fluoride/ silica (1426ppm fluoride as NaF)	Amine Fluoride(AmF) Toothpaste (1400ppmF) Reference toothpaste containing amine fluoride (1400ppm fluoride as AmF)	Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF) Reference toothpaste containing sodium monofluorophosphate and sodium fluoride (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF)	NaF Toothpaste (675ppmF) Study toothpaste containing sodium fluoride and silica (675ppmF as NaF)	Placebo Toothpaste (0ppmF) Placebo fluoride free toothpaste
Treatment Period 1 (14 Days) Adverse Event	1	0	0	0	0
Treatment Period 1 (14 Days) Protocol Violation	1	0	1	0	0
Washout Period 1 (4 Days) Withdrawal by Subject	0	0	0	1	0
Treatment Period 2 (14 Days) Adverse Event	0	1	1	0	0
Treatment Period 2 (14 Days) Protocol Violation	0	0	0	1	0
Treatment Period 2 (14 Days) Withdrawal by Subject	0	0	1	0	0
Treatment Period 3 (14 Days) Protocol Violation	0	1	0	0	1
Treatment Period 4 (14 Days) Protocol Violation	0	1	0	0	0
Treatment Period 4 (14 Days) Other Reason	0	0	0	0	1

Baseline Characteristics

In Situ Caries Model of Fluoride Toothpastes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Randomized Participants n=65 Participants All randomized participants who received at least one dose of the study treatments or who have been evaluated for AEs were included.
Age Continuous	67.0 years STANDARD_DEVIATION 9.97 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Region of Enrollment United States	65 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 14 days

Population: Per protocol (PP) population: All randomized participants who received at least one dose of the study treatments and provided at least one measurement SMH. Participants without any major protocol violations in given study treatment period were included in the PP population.

Outcome measures

Outcome measures
Measure	NaF Toothpaste (1426ppmF) n=56 Participants Study toothpaste containing NaF/ silica (1426ppmF)	AmF Toothpaste (1400ppmF) n=57 Participants Reference toothpaste containing AmF (1400ppmF)	NaMFP/NaF Toothpaste (1450ppmF) Reference toothpaste containing NaMFP/NaF (1450ppmF- 1000ppmF as NaMFP and 450ppmF as NaF)	NaF Toothpaste (675ppmF) Toothpaste containing NaF/silica (675ppmF)	Placebo Toothpaste (0ppmF) Placebo - fluoride free toothpaste
Percent Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF) and AmF Toothpaste (1400ppmF)	38.05 Percentage SMHR Standard Error 2.52	41.06 Percentage SMHR Standard Error 2.53	—	—	—

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: PP population: All randomized participants who received at least one dose of the study treatments or provided at least one measurement SMH. Participants without any major protocol violations in given study treatment period were included in the PP population.

SMH test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH 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. Differences in percent SMH recovery due to study and reference toothpastes were calculated.

Outcome measures

Outcome measures
Measure	NaF Toothpaste (1426ppmF) n=56 Participants Study toothpaste containing NaF/ silica (1426ppmF)	AmF Toothpaste (1400ppmF) n=57 Participants Reference toothpaste containing AmF (1400ppmF)	NaMFP/NaF Toothpaste (1450ppmF) n=58 Participants Reference toothpaste containing NaMFP/NaF (1450ppmF- 1000ppmF as NaMFP and 450ppmF as NaF)	NaF Toothpaste (675ppmF) n=59 Participants Toothpaste containing NaF/silica (675ppmF)	Placebo Toothpaste (0ppmF) n=59 Participants Placebo - fluoride free toothpaste
Percent SMH Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste (1400ppm F) and Placebo (0ppmF)	38.05 Percentage SMHR Standard Error 2.52	41.06 Percentage SMHR Standard Error 2.53	33.48 Percentage SMHR Standard Error 2.49	29.08 Percentage SMHR Standard Error 2.50	14.49 Percentage SMHR Standard Error 2.48

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: PP population: All randomized participants who received at least one dose of the study treatments or provided at least one significant measurement of fluoride uptake. Participants without any major protocol violations in given study treatment period were included in the PP population.

Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.