Evaluation of Efficacy of Experimental Gel to Foam Dentifrices in Dental Erosion
Completed · Not applicable
Conditions studied: Dental Erosion, Acid Wear
In brief
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.
Key facts
- Study ID
- NCT01657903
- Run by
- GlaxoSmithKline
- People needed
- 56
- Starts
- 2011-11-01
- Expected to finish
- 2012-02-01
- Last updated by the study team
- 2015-01-26
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Indiana University School of Dentistry — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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