Effect of Fluoride in a Dentifrice on Remineralization of Erosive Lesions

NCT ID: NCT01641237

Last Updated: 2014-07-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-05-31

Brief Summary

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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

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Conditions

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Enamel Erosion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Low ppm fluoride dentifrice

Low ppm fluoride as sodium fluoride in a silica base dentifrice

Group Type EXPERIMENTAL

sodium fluoride

Intervention Type DRUG

fluoride as sodium fluoride

Medium ppm fluoride dentifrice

Medium ppm fluoride as sodium fluoride in a silica base dentifrice

Group Type EXPERIMENTAL

sodium fluoride

Intervention Type DRUG

fluoride as sodium fluoride

High ppm fluoride dentifrice

High ppm fluoride as sodium fluoride in a silica base dentifrice

Group Type EXPERIMENTAL

sodium fluoride

Intervention Type DRUG

fluoride as sodium fluoride

No fluoride dentifrice

no added fluoride in a silica base dentifrice

Group Type PLACEBO_COMPARATOR

no added fluoride in a silica base

Intervention Type DRUG

no added fluoride

Interventions

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sodium fluoride

fluoride as sodium fluoride

Intervention Type DRUG

no added fluoride in a silica base

no added fluoride

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Indiana University School of Dentistry

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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RH01299

Identifier Type: -

Identifier Source: org_study_id

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