Trial Outcomes & Findings for Experimental Dentifrice Remineralization/Fluoride Uptake in an in Situ Model (NCT NCT00752089)

NCT ID: NCT00752089

Last Updated: 2016-12-08

Results Overview

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 re-hardening of enamel surface. Percent SMHR 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

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Baseline to 14 days

Results posted on

2016-12-08

Participant Flow

Participants were recruited at the clinical site.

Two to three days before the start of each treatment period participants got their teeth cleaned to remove all accessible plaque and calculus, and were provided with a fluoride free dentifrice for maintaining wash-out period and standardizing the oral conditions.

Participant milestones

Participant milestones
Measure	Overall Study This was a single-center, examiner blind, randomized, controlled, four treatment cross-over study. Participants have used each study product twice per day for two weeks and participated in each of the four treatment periods.
Overall Study STARTED	20
Overall Study Received NaF/ KNO3/ 2% Isopentane	19
Overall Study Received NaF/KNO3/ 0% Isopentane	17
Overall Study Received NaF	18
Overall Study Received Placebo	18
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Overall Study This was a single-center, examiner blind, randomized, controlled, four treatment cross-over study. Participants have used each study product twice per day for two weeks and participated in each of the four treatment periods.
Overall Study Adverse Event	1
Overall Study Protocol Deviation	2
Overall Study Could not attend visit 9	1
Overall Study Not capable of wearing partial denture	1
Overall Study Cannot continue the study	1

Baseline Characteristics

Experimental Dentifrice Remineralization/Fluoride Uptake in an in Situ Model

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study Participants n=20 Participants All randomized participants who received all four treatments NaF/ KNO3/ 2% isopentane Dentifrice, NaF/KNO3/ 0% isopentane Dentifrice, NaF Dentifrice, and placebo were included in the baseline assessment.
Age, Continuous	65.31 years STANDARD_DEVIATION 8.226 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	20 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 product, had at least one post-baseline efficacy assessments and no major protocol deviations. Missing data was not imputed. Due to drop-outs, there were differences in the "n" per treatment group.

Outcome measures

Outcome measures
Measure	NaF/ KNO3/ 2% Isopentane Dentifrice n=17 Participants Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as NaF and 5% KNO3 and as an excipient ingredient: 2% isopentane.	NaF/KNO3/ 0% Isopentane Dentifrice n=17 Participants Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane.	NaF Dentifrice n=17 Participants Participants brushed their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF.	Placebo Dentifrice n=18 Participants Participants brushed their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).
Percentage Surface Micro-hardness Recovery (SMHR) of Enamel Specimens	39.46 % SMHR 95% Confidence Interval 4.10 • Interval 31.17 to 47.75	38.31 % SMHR 95% Confidence Interval 4.11 • Interval 30.0 to 46.62	36.17 % SMHR 95% Confidence Interval 4.10 • Interval 27.89 to 44.44	17.26 % SMHR 95% Confidence Interval 4.04 • Interval 9.08 to 25.43

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: PP population: All randomized participants who received at least one dose of study product, had at least one post-baseline efficacy assessments and no major protocol deviations. Missing data was not imputed. Due to drop-outs, there were differences in the "n" per treatment group.

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 and expressed as ug\*F/cm\^3. The difference between treatments was calculated with respect to fluoride uptake by enamel.

Outcome measures

Outcome measures
Measure	NaF/ KNO3/ 2% Isopentane Dentifrice n=17 Participants Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as NaF and 5% KNO3 and as an excipient ingredient: 2% isopentane.	NaF/KNO3/ 0% Isopentane Dentifrice n=17 Participants Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane.	NaF Dentifrice n=17 Participants Participants brushed their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF.	Placebo Dentifrice n=18 Participants Participants brushed their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).
Adjusted Mean Change From Baseline in Enamel Fluoride Uptake	2445.86 ug*F/cm^3 95% Confidence Interval 256.55 • Interval 1926.9 to 2694.82	2767.30 ug*F/cm^3 95% Confidence Interval 257.16 • Interval 2247.1 to 3287.5	2518.54 ug*F/cm^3 95% Confidence Interval 256.55 • Interval 2000.28 to 3036.8	661.18 ug*F/cm^3 95% Confidence Interval 252.88 • Interval 148.91 to 1173.46

Adverse Events

NaF/ KNO3/ 2 % Isopentane Dentifrice

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

NaF/KNO3/ 0% Isopentane Dentifrice

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

NaF Dentifrice

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo Dentifrice

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	NaF/ KNO3/ 2 % Isopentane Dentifrice n=17 participants at risk Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as NaF and 5% KNO3 and as an excipient ingredient: 2% isopentane.	NaF/KNO3/ 0% Isopentane Dentifrice n=17 participants at risk Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane.	NaF Dentifrice n=18 participants at risk Participants brushed their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF.	Placebo Dentifrice n=18 participants at risk Participants brushed their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).
Gastrointestinal disorders Gingival erythema	0.00% 0/17 • Up to 13 weeks	5.9% 1/17 • Number of events 2 • Up to 13 weeks	11.1% 2/18 • Number of events 2 • Up to 13 weeks	0.00% 0/18 • Up to 13 weeks
Gastrointestinal disorders Gingival ulceration	0.00% 0/17 • Up to 13 weeks	5.9% 1/17 • Number of events 1 • Up to 13 weeks	5.6% 1/18 • Number of events 1 • Up to 13 weeks	0.00% 0/18 • Up to 13 weeks
Gastrointestinal disorders Food poisoning	0.00% 0/17 • Up to 13 weeks	0.00% 0/17 • Up to 13 weeks	0.00% 0/18 • Up to 13 weeks	5.6% 1/18 • Number of events 1 • Up to 13 weeks
Gastrointestinal disorders Tongue coated	0.00% 0/17 • Up to 13 weeks	0.00% 0/17 • Up to 13 weeks	0.00% 0/18 • Up to 13 weeks	5.6% 1/18 • Number of events 1 • Up to 13 weeks
Infections and infestations Localised infection	5.9% 1/17 • Number of events 1 • Up to 13 weeks	0.00% 0/17 • Up to 13 weeks	0.00% 0/18 • Up to 13 weeks	0.00% 0/18 • Up to 13 weeks
Infections and infestations Nasopharyngitis	0.00% 0/17 • Up to 13 weeks	5.9% 1/17 • Number of events 1 • Up to 13 weeks	0.00% 0/18 • Up to 13 weeks	0.00% 0/18 • Up to 13 weeks
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/17 • Up to 13 weeks	0.00% 0/17 • Up to 13 weeks	5.6% 1/18 • Number of events 1 • Up to 13 weeks	0.00% 0/18 • Up to 13 weeks
Infections and infestations Tooth infection	5.9% 1/17 • Number of events 1 • Up to 13 weeks	0.00% 0/17 • Up to 13 weeks	0.00% 0/18 • Up to 13 weeks	0.00% 0/18 • Up to 13 weeks

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place