Trial Outcomes & Findings for Evaluation of a Test Mouthwash and Dentifrice Regimen in an In-situ Model of Dental Erosion (NCT NCT01128972)

Last Updated: 2015-01-01

Results Overview

Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: \[(E1-E2)/ (E1-B)\]\*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

Baseline, 4 hours post treatment in each treatment period

Results posted on

2015-01-01

Participant Flow

Participants were recruited at the clinical site.

Two days, prior to each treatment visit ,participants used a fluoride- free dentifrice twice daily to avoid any carry over effect.

Participant milestones

Participant milestones
Measure	Test Dentifrice + Test Mouth Rinse (MR) Participants were administered with treatment regimen comprising of test sodium fluoride (NaF) dentifrice \[containing 1450 parts per million (ppm) fluoride (F) as NaF and potassium nitrate (KNO3)\] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5 gram (g) test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.	Test Dentifrice + Sterile Water Rinse Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.	Reference Dentifrice + Sterile Water Rinse Participants were administered with treatment regimen comprising of reference sodium monofluorophosphate (NaMFP)/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.	Placebo Dentifrice + Sterile Water Rinse Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.	Placebo Dentifrice + Test MR Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and test MR containing NaF (450ppmF). The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
Period I STARTED	7	7	7	7	8
Period I COMPLETED	7	7	7	7	8
Period I NOT COMPLETED	0	0	0	0	0
Period II STARTED	7	7	7	8	7
Period II COMPLETED	7	7	7	8	7
Period II NOT COMPLETED	0	0	0	0	0
Period III STARTED	7	7	8	7	7
Period III COMPLETED	7	7	8	7	7
Period III NOT COMPLETED	0	0	0	0	0
Period IV STARTED	7	8	7	7	7
Period IV COMPLETED	7	8	7	7	7
Period IV NOT COMPLETED	0	0	0	0	0
Period V STARTED	8	7	7	7	7
Period V COMPLETED	8	7	7	7	7
Period V NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of a Test Mouthwash and Dentifrice Regimen in an In-situ Model of Dental Erosion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=36 Participants All randomized participants were included for baseline evaluation.
Age, Continuous	37.0 Years STANDARD_DEVIATION 12.90 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 4 hours post treatment in each treatment period

Population: Per protocol (PP) population: All randomized subjects who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.

Outcome measures

Outcome measures
Measure	Test Dentifrice + Test MR n=36 Participants Participants were administered with treatment regimen comprising of test NaF dentifrice \[containing 1450ppmF as NaF and KNO3\] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.	Test Dentifrice + Sterile Water Rinse n=36 Participants Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.	Reference Dentifrice + Sterile Water Rinse n=36 Participants Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.	Placebo Dentifrice + Sterile Water Rinse n=36 Participants Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.	Placebo Dentifrice + Sterile Water Rinse Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
Adjusted Mean Percent Net Erosion Resistance (NER) of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1) Test Dentifrice+ Sterile Water Rinse 2) Reference Dentifrice+ Sterile Water Rinse 3) Placebo Dentifrice+ Sterile Water Rinse	-2.88 Percent NER Standard Error 2.155	-14.54 Percent NER Standard Error 2.155	-29.48 Percent NER Standard Error 2.155	-40.05 Percent NER Standard Error 2.155	—

SECONDARY outcome

Timeframe: Baseline, 4 hours post treatment in each treatment period.

Population: PP population: All randomized participants who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.

SMH test was used to assess 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. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: \[(E1-R)/ (E1-B)\]\*100.

Outcome measures

Outcome measures
Measure	Test Dentifrice + Test MR n=36 Participants Participants were administered with treatment regimen comprising of test NaF dentifrice \[containing 1450ppmF as NaF and KNO3\] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.	Test Dentifrice + Sterile Water Rinse n=36 Participants Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.	Reference Dentifrice + Sterile Water Rinse n=36 Participants Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.	Placebo Dentifrice + Sterile Water Rinse n=36 Participants Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.	Placebo Dentifrice + Sterile Water Rinse Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
Adjusted Mean Percentage Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1)Test Dentifrice+Sterile Water Rinse 2)Reference Dentifrice+Sterile Water Rinse 3)Placebo Dentifrice+ Sterile Water Rinse	42.14 Percent SMH Standard Error 1.399	38.02 Percent SMH Standard Error 1.399	30.88 Percent SMH Standard Error 1.399	30.57 Percent SMH Standard Error 1.399	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 4 hours post treatment in each treatment period

Population: PP population: All randomized subjects who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.

Outcome measures

Outcome measures
Measure	Test Dentifrice + Test MR n=36 Participants Participants were administered with treatment regimen comprising of test NaF dentifrice \[containing 1450ppmF as NaF and KNO3\] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.	Test Dentifrice + Sterile Water Rinse n=36 Participants Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.	Reference Dentifrice + Sterile Water Rinse n=36 Participants Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.	Placebo Dentifrice + Sterile Water Rinse n=36 Participants Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.	Placebo Dentifrice + Sterile Water Rinse n=36 Participants Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
Adjusted Mean Percent NER of Enamel Specimens Exposed to a Treatment Regimen of Placebo Dentifrice + Test MR Relative to: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water Rinse 3) Reference Dentifrice +Sterile Water Rinse	-3.76 Percent NER Standard Error 2.155	-2.88 Percent NER Standard Error 2.155	-14.54 Percent NER Standard Error 2.155	-29.48 Percent NER Standard Error 2.155	-40.05 Percent NER Standard Error 2.155

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 4 hours post treatment in each treatment period

Population: PP population: All randomized participants who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.

Outcome measures

Outcome measures
Measure	Test Dentifrice + Test MR n=36 Participants Participants were administered with treatment regimen comprising of test NaF dentifrice \[containing 1450ppmF as NaF and KNO3\] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.	Test Dentifrice + Sterile Water Rinse n=36 Participants Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.	Reference Dentifrice + Sterile Water Rinse n=36 Participants Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.	Placebo Dentifrice + Sterile Water Rinse n=36 Participants Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.	Placebo Dentifrice + Sterile Water Rinse n=36 Participants Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
Adjusted Mean Percentage SMH Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to Following Treatment Regimens: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water 3) Reference Dentifrice +Sterile Water	37.75 Percent SMH Standard Error 1.399	42.14 Percent SMH Standard Error 1.399	38.02 Percent SMH Standard Error 1.399	30.88 Percent SMH Standard Error 1.399	30.57 Percent SMH Standard Error 1.399

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 4 hours post treatment in each treatment period

Population: PP population: All randomized subjects who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.

Outcome measures

Outcome measures
Measure	Test Dentifrice + Test MR n=36 Participants Participants were administered with treatment regimen comprising of test NaF dentifrice \[containing 1450ppmF as NaF and KNO3\] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.	Test Dentifrice + Sterile Water Rinse n=36 Participants Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.	Reference Dentifrice + Sterile Water Rinse Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.	Placebo Dentifrice + Sterile Water Rinse Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.	Placebo Dentifrice + Sterile Water Rinse Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
Adjusted Mean Percent NER of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse	-2.88 Percent NER Standard Error 2.155	-29.48 Percent NER Standard Error 2.155	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 4 hours post treatment in each treatment period

Population: PP population: All randomized subjects who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.

Outcome measures

Outcome measures
Measure	Test Dentifrice + Test MR n=36 Participants Participants were administered with treatment regimen comprising of test NaF dentifrice \[containing 1450ppmF as NaF and KNO3\] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.	Test Dentifrice + Sterile Water Rinse n=36 Participants Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.	Reference Dentifrice + Sterile Water Rinse Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.	Placebo Dentifrice + Sterile Water Rinse Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.	Placebo Dentifrice + Sterile Water Rinse Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
Adjusted Mean Percent SMH Recovery of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse	38.02 Percent SMH Standard Error 1.399	30.88 Percent SMH Standard Error 1.399	—	—	—

Adverse Events

Test Dentifrice + Test MR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Test Dentifrice + Sterile Water Rinse

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Reference Dentifrice + Sterile Water Rinse

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo Dentifrice + Test MR

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo Dentifrice + Sterile Water Rinse

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Test Dentifrice + Test MR n=36 participants at risk Participants were administered with treatment regimen comprising of test NaF dentifrice \[containing 1450ppmF as NaF and KNO3\] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.	Test Dentifrice + Sterile Water Rinse n=36 participants at risk Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.	Reference Dentifrice + Sterile Water Rinse n=36 participants at risk Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.	Placebo Dentifrice + Test MR n=36 participants at risk Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and test MR containing NaF (450ppmF). The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.	Placebo Dentifrice + Sterile Water Rinse n=36 participants at risk Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
Gastrointestinal disorders Gingival Erythema	0.00% 0/36 • All AEs 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.	2.8% 1/36 • Number of events 1 • All AEs 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.	5.6% 2/36 • Number of events 2 • All AEs 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.	2.8% 1/36 • Number of events 1 • All AEs 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.	0.00% 0/36 • All AEs 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.

Additional Information

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