Evaluation of Efficacy of Experimental Gel to Foam Dentifrices in Dental Erosion

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare and evaluate the ability of two European Union (EU) regulated gel to foam toothpaste formulations versus a non-fluoride toothpaste using a modified in-situ model of dental erosion and remineralization. A positive control i.e fluoride containing toothpaste marketed in EU will also be compared to non-fluoride toothpaste.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluorides; Listerine; Sodium Fluoride

Criteria

Inclusion Criteria:

• General and Oral Health: Good general health with (in the opinion of the investigator) no clinically OST and OHT examinations.

• Oral Requirements:

• 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.

• A gum base stimulated whole saliva flow rate ≥ 0.8 g/min and an unstimulated whole saliva flow rate ≥ 0.2 g/min.

• Contraception: Women of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception.

Exclusion Criteria:

• Oral Health:

• Current active caries or periodontal disease that may compromise the study or the health of the subjects.

• Lesions of the oral cavity that could interfere with the study evaluations, including severe gingivitis, grossly carious lesions, periodontitis and other severe periodontal disease.

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

• Clinical Study/Experimental Medication:

• Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit

• Previous participation in this study

• Substance abuse: Recent history (within the last year) of alcohol or other substance abuse.

• Pregnancy: Women who are pregnant or who are intending to become pregnant over the duration of the study

• Breast-feeding: Women who are breast-feeding