Evaluation of a Test Mouthwash and Dentifrice Regimen in an In-situ Model of Dental Erosion

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Tooth Erosion

Treatments: Drug: Sodium monoflurophosphate; Drug: Sodium fluoride; Drug: Sterile water

Study type: Interventional

Funder types: Industry

Identifiers

NCT01128972

Z3480664

Details and patient eligibility

About

An in situ model will be used to evaluate and compare enamel remineralization of bovine enamel specimens.

Enrollment: 36 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• An intact maxillary dental arch suitable for the retention of the palatal appliance and an intact mandibular dental arch - subjects may have fixed bridges replacing missing teeth
• No current active caries or periodontal disease that may compromise the study or the health of the subjects
• A gum base stimulated whole saliva flow rate greater than or equal to 0.8 mL/minute and an unstimulated whole saliva flow rate greater than or equal to 0.2 mL/minute

Exclusion criteria

• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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36 participants in 5 patient groups, including a placebo group

Test Dentifrice + Test Mouth Rinse (MR)

Experimental group

Description:

Test fluoride dentifrice and test fluoride MR

Treatment:

Drug: Sodium fluoride

Test Dentifrice + Sterile Water Rinse

Experimental group

Description:

Test fluoride dentifrice and sterile water rinse

Treatment:

Drug: Sodium fluoride

Drug: Sterile water

Placebo Dentifrice + Test MR

Experimental group

Description:

Placebo dentifrice and test fluoride rinse

Treatment:

Drug: Sodium fluoride

Reference Dentifrice + Sterile Water Rinse

Active Comparator group

Description:

Marketed fluoride dentifrice with sterile water rinse

Treatment:

Drug: Sodium monoflurophosphate

Drug: Sodium fluoride

Drug: Sterile water

Placebo Dentifrice + Sterile Water Rinse

Placebo Comparator group

Description:

Placebo dentifrice and sterile water rinse

Treatment:

Drug: Sterile water