N/A
N=56
Evaluation of Efficacy of Experimental Gel to Foam Dentifrices in Dental Erosion
Dental Erosion · Acid Wear
Bottom Line
View on ClinicalTrials.gov: NCT01657903 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: Relative Erosion Resistance (RER) of Enamel Specimens Post 4 Hours of Treatment Exposure — -36.66; -36.53; -36.98; -77.82 Percentage RER — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sodium Fluoride (Drug); Potassium nitrate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative Erosion Resistance (RER) of Enamel Specimens Post 4 Hours of Treatment Exposure |
-36.66; -36.53; -36.98; -77.82 | <0.0001 sig |
| PRIMARY Surface Microhardness (SMH) Recovery of Enamel Specimens Post 4 Hours of Treatment Exposure |
32.24; 32.32; 34.53; 22.87 | <0.0001 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01657903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.