E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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% |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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
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E.4 | Principal 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) |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Fluoride fluid, 0.5% fluoride |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
See study protocol, Sections 8.5 and 8.6, Pages 18-19 |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |