caries lesions
Conditions
Interventions
Trade Name: elmex® fluid
Product Name: elmex® fluid
Product Code: -
Pharmaceutical Form: Dental solution
INN or Proposed INN: olaflur
CAS Number: 6818-37-7
Concentration unit: g gram(s)
Concentration
Sponsors
GABA GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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% 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 | — |
Countries
Germany
Outcome results
None listed