Remineralization, fluoride uptake, and lesion depth of sound and demineralized, plaque-covered enamel after the application of elmex gel will be tested in situ in comparison to a placebo gel.
Conditions
Sponsors
GABA International AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent • Healthy volunteers • Age 18 - 60 years • Presence of at least 20 teeth excluding the wisdom teeth • Healthy or prosthetically, conservatively and periodontally restored dentition • Average oral hygiene (cleaning the teeth at least twice a day) • Agreement of test subject not to use any oral hygiene products other than the study products and toothpaste provided for the duration of the study; the use of dental floss and interdental brush is allowed • Flow rate of stimulated saliva = 0.7 ml/min (Dentobuff Kit) • Moderate to high buffer capacity of saliva • Woman of childbearing potential: highly effective method of birth control during the whole study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Ongoing oral or dental treatment except emergency treatment • Known hypersensitivity or allergy to study products and standard toothpaste ingredients and/or dental material used in the present study • Unphysiological mobility of the teeth • Pathological changes of the oral mucosa, e.g. acute ulcerating gingivitis, acute herpetic gingivostomatitis, recurrent aphthous ulceration or systemic illnesses with oral manifestations • Use of highly concentrated fluoride products like gels, tablets, varnishes, fillings etc. or of erosive bronchiolytics or antiasthmatics within 30 days prior to the planned insertion of the intra-oral specimen holder and during the whole study • Known pregnancy or breast feeding during the course of the study • Participation in a clinical trial or receipt of an investigational compound/treatment within the last 30 days • Antibiotic therapy within the past 3 months • Eating disorders (e.g. bulimia, anorexia nervosa)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary study parameter is to determine the mineral change of sound and demineralized plaque-covered enamel specimens four weeks after single application of a 1.25% fluoride gel or a placebo gel.;Secondary Objective: The secondary study parameter are the overall fluoride uptake and the change in lesion depth of sound and demineralized plaque-covered enamel specimens four weeks after single application of a 1.25% fluoride gel or a placebo gel.;Primary end point(s): 1. The single tray application of 1.25% fluoride gel (elmex® gelée) reduces the progression of the demineralization or remineralizes initial carious lesion more than a placebo gel does. 2. The single tray application of 1.25% fluoride gel (elmex® gelée) reduces the progression of the demineralization of sound enamel more than a placebo gel does. | — |
Countries
Germany
Outcome results
None listed