In situ mineral change and fluoride retention ofsound and demineralized enamel in high cariogenicmilieus following the single application of a 1.25%-fluoride or a placebo gel.

• Conditions: 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.

• Registration Number: EUCTR2008-008594-58-DE
• Lead Sponsor: GABA International AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

• 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary study parameter is to determine the mineral change of sound and demineralized plaque-covered<br>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<br>demineralized plaque-covered enamel specimens four weeks after single application of a 1.25% fluoride gel<br>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<br>demineralization or remineralizes initial carious lesion more than a placebo gel does.<br><br>2. The single tray application of 1.25% fluoride gel (elmex® gelée) reduces the progression of the<br>demineralization of sound enamel more than a placebo gel does.