E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 |
To identify benefit-costs of the treatment in a primary dental care setting |
|
E.2.2 | Secondary objectives of the trial |
To identify daily clinical need in a primary dental care setting. To identify cost of the applying Prevora Stage 1 in various primary dental care settings. To identify willigness to pay for treatment. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- 40 years of age and older - dentate - signs of active tooth decay at the crown and/or the root OR - risk of dental caries in the future by way of gum recession and these additional risk factors: o history of caries in the past 2 years o removable partial denture o limited salivary flow o multiple medication use o ongoing periodontal disease - willingness to pay for treatment - willing and able to provide informed consent - women with childbearing potential if using an effective method of contraception during the course of the trial - willing to pay for the dental professional fees associated with Prevora's treatment (note that the study medication is provided at no charge to the study participant as per article 19, European Directive 2001/20/EC, and as outlined in the protocol) - not participating in another study |
|
E.4 | Principal exclusion criteria |
- pregnant or planning to become pregnant in the next 12 months - nursing mother - allergic to any of the ingrediants of Prevora Stage 1 (chlorhexidine diacetate, Sumatra benzoin, alcohol) and Prevora Sealant Stage 2 (ammonio methacrylate copolymer Type B, triethyl citrate) - patients who received in the last 3 days before study treatment any fluoride gel, including "elmex gelee", or directly before treatment any oil-based prophylactic - investigator discretion that the participant will not complete the study's activities - participating in another study |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is a benefit-cost assessment of a new preventive treatment for older adults at risk of dental caries within the setting of primary dental care clinics. Secondary endpoints are daily need, cost of providing this treatment and willigness to pay. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
|
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 | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
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 | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
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
|
4 wekly treatments per participant |
|
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 | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 2 |