Trial Outcomes & Findings for Enamel Remineralization Potential of Dentifrices in Situ (NCT NCT01128946)

Last Updated: 2015-01-01

Results Overview

SMH test was used to assess mineral status of partially demineralized enamel specimens using 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/demineralization, while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline(B), after intra-oral exposure(R) and after in-vitro demineralization(D) using formula: \[(D-R)/(D-B)\]\*100.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

83 participants

Primary outcome timeframe

Baseline to 14 days

Results posted on

2015-01-01

Participant Flow

Participants were recruited at the clinical site.

Two to three days before the start of each treatment period, participants received a professional dental cleaning of their natural teeth, then brushed with the study wash out toothpaste and toothbrush.

Participant milestones

Participant milestones
Measure	Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 gram (g) NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 milliliters (mL) water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF Participants brushed their natural teeth twice daily, for one timed minute with 1.5g NaMFP and NaF toothpaste (1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures	Strontium Fluoride (SnF)/NaF Toothpaste (1450ppmF Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	NaF Toothpaste (675ppmF Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
Period I STARTED	20	21	21	21
Period I COMPLETED	20	20	20	20
Period I NOT COMPLETED	0	1	1	1
Period II STARTED	20	20	20	20
Period II COMPLETED	20	19	20	19
Period II NOT COMPLETED	0	1	0	1
Period III STARTED	20	19	20	19
Period III COMPLETED	19	19	20	19
Period III NOT COMPLETED	1	0	0	0
Period IV STARTED	19	20	19	19
Period IV COMPLETED	19	20	19	19
Period IV NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 gram (g) NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 milliliters (mL) water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF Participants brushed their natural teeth twice daily, for one timed minute with 1.5g NaMFP and NaF toothpaste (1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures	Strontium Fluoride (SnF)/NaF Toothpaste (1450ppmF Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	NaF Toothpaste (675ppmF Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
Period I Protocol Violation	0	1	0	0
Period I Withdrawal by Subject	0	0	1	1
Period II Protocol Violation	0	1	0	0
Period II Withdrawal by Subject	0	0	0	1
Period III Protocol Violation	1	0	0	0

Baseline Characteristics

Enamel Remineralization Potential of Dentifrices in Situ

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=83 Participants All randomized participants
Age, Continuous	64.0 Years STANDARD_DEVIATION 8.73 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Region of Enrollment United States	83 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 study treatment and with at least one post-baseline efficacy assessment but did not have any major protocol violations. Missing data was not imputed. Due to drop outs, there were differences in number of participants (N) per treatment group.

Outcome measures

Outcome measures
Measure	NaF Toothpaste (1450ppmF) n=78 Participants Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	SnF/NaF Toothpaste (1450ppmF) n=79 Participants Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	SnF/NaF Toothpaste (1450ppmF) Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	NaF Toothpaste (675ppmF) Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and SnF/NaF Toothpaste (1450ppmF)	40.94 Percentage of SMHR Standard Error 1.930	17.88 Percentage of SMHR Standard Error 1.924	—	—

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: PP population: All randomized participants, who received at least one dose of study treatment and with at least one post-baseline efficacy assessment but did not have any major protocol violations. Missing data was not imputed. Due to drop outs, there were differences in number of participants (N) per treatment group

Outcome measures

Outcome measures
Measure	NaF Toothpaste (1450ppmF) n=78 Participants Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	SnF/NaF Toothpaste (1450ppmF) n=78 Participants Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	SnF/NaF Toothpaste (1450ppmF) n=79 Participants Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	NaF Toothpaste (675ppmF) n=76 Participants Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
%SMHR of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF)	40.94 Percentage Standard Error 1.93	30.19 Percentage Standard Error 1.932	17.88 Percentage Standard Error 1.924	28.74 Percentage Standard Error 1.943

SECONDARY outcome

Timeframe: Baseline to 14 days

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.

Outcome measures

Outcome measures
Measure	NaF Toothpaste (1450ppmF) n=78 Participants Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	SnF/NaF Toothpaste (1450ppmF) n=78 Participants Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	SnF/NaF Toothpaste (1450ppmF) n=79 Participants Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	NaF Toothpaste (675ppmF) n=76 Participants Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
Change From Baseline in Enamel Fluoride Uptake Upon Exposure to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF)	22.23 micrograms (μg)*F/centimeters(cm)^2] Standard Error 0.853	13.54 micrograms (μg)*F/centimeters(cm)^2] Standard Error 0.854	9.13 micrograms (μg)*F/centimeters(cm)^2] Standard Error 0.850	14.31 micrograms (μg)*F/centimeters(cm)^2] Standard Error 0.861

Adverse Events

NaF Toothpaste (1450ppmF)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

NaF Toothpaste (675ppmF)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

NaMFP/NaF Toothpaste (1450ppmF)

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

SnF/NaF Toothpaste (1450ppmF)

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	NaF Toothpaste (1450ppmF) n=79 participants at risk Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	NaF Toothpaste (675ppmF) n=79 participants at risk Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	NaMFP/NaF Toothpaste (1450ppmF) n=80 participants at risk Participants brushed their natural teeth twice daily, for one timed minute with 1.5g NaMFP and NaF toothpaste (1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	SnF/NaF Toothpaste (1450ppmF) n=80 participants at risk Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
Cardiac disorders Coronary Artery Disease	0.00% 0/79 • All adverse events 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% 0/79 • All adverse events 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.	1.2% 1/80 • Number of events 1 • All adverse events 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% 0/80 • All adverse events 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.

Other adverse events

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