Effect of Fluoride in a Dentifrice on Remineralization of Erosive Lesions

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Enamel Erosion

Treatments: Drug: sodium fluoride; Drug: no added fluoride in a silica base

Study type: Interventional

Funder types: Industry

Identifiers

NCT01641237

RH01299

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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72 participants in 4 patient groups, including a placebo group

Low ppm fluoride dentifrice

Experimental group

Description:

Low ppm fluoride as sodium fluoride in a silica base dentifrice

Treatment:

Drug: sodium fluoride

Medium ppm fluoride dentifrice

Experimental group

Description:

Medium ppm fluoride as sodium fluoride in a silica base dentifrice

Treatment:

Drug: sodium fluoride

High ppm fluoride dentifrice

Experimental group

Description:

High ppm fluoride as sodium fluoride in a silica base dentifrice

Treatment:

Drug: sodium fluoride

No fluoride dentifrice

Placebo Comparator group

Description:

no added fluoride in a silica base dentifrice

Treatment:

Drug: no added fluoride in a silica base