Fluoride uptake and remineralisation of incipient carious lesions following the application of fluoride fluids with different fluoride concentrations -

• Conditions: caries lesions

• Registration Number: EUCTR2004-002366-38-DE
• Lead Sponsor: GABA GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10-04
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

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

Inclusion Criteria

Written declaration of informed consent
Age 18-60 years
At least 20 teeth
Good general health, as assessed by investigator
Healthy or prosthetically, restored and periodontally-sound dentition
Average oral hygiene (cleaning the teeth at least twice a day)
Agreement of test subjects not to use any oral hygiene products other than the test products and toothpaste provided for the duration of the study; the use of non-fluoridated oral hygiene agents is allowed
Flow rate of stimulated saliva = 0.7 ml/min
Moderate to high buffer capacity of saliva

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 for emergency treatment
Known allergic reaction to an oral hygiene product and/or medication and/or dental material previously used in the mouth or pharynx
Existing allergy to one of teh components of the test products or the standard toothpaste
Unphysiological mobility of the teeth
Pathological changes of the oral mucusa, eg. acute ulcerating gingivitis, acute herpetic gingivostomatitis, recurrent aphthous ulceration or systemic illnesses with oral manifestations
Use of fluoride-containing products (Pastes, mouthrinses) within 14 days prior to the introduction of the intra-oral appliances
Use of fluoride-containing products: gels, tablets, varnishes, fillings etc., or of erosive bronchiolytics or anti-asthmatics within 30 days prior to the introduction of the intra-oral specimen holder
Pregnancy or breast feeding
Participation in another clinical trial either currently or within the last 30 days
Antibiotic therapy within the past 3 months
Any non-permitted therapy
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 application of the fluid with a concentration of 1.0% fluoride leads to a higher fluoride uptake than the application of a fluid with a fluoride concentration of 0.5%;Secondary Objective: 1. The application of the fluid with a concentration of 1.0 % fluoride leads to greater remineralisation than the application of a fluid with a fluoride concentration of 0.5%<br><br>2. The application of the fluid with a concentration of 0.5% fluoride is superior to placebo with respect to fluoride uptake and remineralisation.;Primary end point(s): Fluoride uptake