E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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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 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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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) |
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E.5 End points |
E.5.1 | 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. |
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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 | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 | No |
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 | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | No |
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
|
The end of the trial occurs with the final visit of the last randomized subject |
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | 84 |