Effect of Fluoride in a Dentifrice on Remineralization of Erosive Lesions

Phase 3

Completed

• Conditions: Enamel Erosion
• Interventions: Drug: sodium fluoride; Drug: no added fluoride in a silica base

• Registration Number: NCT01641237
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The proposed study will evaluate the performance of fluoride delivered from a new dentifrice formulation without potassium nitrate. It will also evaluate the dose-response to fluoride by testing four dentifrices covering a range of sodium fluoride concentration.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Study First Submitted: 2012-07-12
• Study First Submitted QC: 2012-07-13
• Study First Posted: 2012-07-16
• Results First Submitted: 2013-05-30
• Results First Submitted QC: 2013-05-30
• Results First Posted: 2013-07-31
• Status Verified: 2014-06
• Last Update Submitted: 2014-07-17
• Last Update Posted: 2014-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• intact maxillary dental arch suitable to retain a palatal appliance, an intact mandibular dental arch and a stimulated/unstimulated saliva flow rate of ≥ 0.8 milliliter/minute (ml/min) and ≥ 0.2 ml/min respectively.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High ppm fluoride dentifrice	sodium fluoride	High ppm fluoride as sodium fluoride in a silica base dentifrice
No fluoride dentifrice	no added fluoride in a silica base	no added fluoride in a silica base dentifrice
Low ppm fluoride dentifrice	sodium fluoride	Low ppm fluoride as sodium fluoride in a silica base dentifrice
Medium ppm fluoride dentifrice	sodium fluoride	Medium ppm fluoride as sodium fluoride in a silica base dentifrice

Primary Outcome Measures

Name	Time	Method
Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship	Baseline to 4 hours	SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR 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 SMHR 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.

Secondary Outcome Measures

Name	Time	Method
Enamel Fluoride Uptake (Corrected Data)	Baseline to 4 hours	Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of fluoride divided by area of the enamel cores. Data analysis was based on corrected data.
%SMHR	Baseline to 4 hours	SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR 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 SMHR 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.
Percentage Relative Erosion Resistance	Baseline to 4 hours	Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine relative erosion resistance which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent relative erosion resistance was calculated by formula: \[(E1-E2)/ (E1-B)\]\*100.

Trial Locations

Locations (1)

Indiana University School of Dentistry; 🇺🇸 Indianapolis, Indiana, United States