E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012318 |
E.1.2 | Term | Dental caries |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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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 compare over a 3 year period the effectiveness of 22,600 ppm fluoride varnish, 1,450 ppm fluoride toothpaste, toothbrush and standardised health education, provided twice a year, as a preventive package, with standardised health education alone provided twice a year in: preventing the conversion of children from caries−free to caries−active states in the primary dentition • reducing the number of carious surfaces (caries into dentine) in the primary dentition in children who convert from caries free to caries active states • preventing episodes of pain and extraction of primary teeth in 2 and 3 year−old children who are caries free at baseline and who attend primary care dental services.
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E.2.2 | Secondary objectives of the trial |
To compare over a 3 year period the costs of dental care in a group receiving 22,600 ppm fluoride varnish, 1,450 ppm fluoride toothpaste, toothbrush and standardised health education, provided twice a year as a preventive package with a group receiving standardised health education alone provided twice a year, in 2 and 3 year−old children who are caries free at baseline and who attend primary care dental services.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Children aged 2 and 3 years • Attending selected GDS practices • Person with parental responsibility signs a Consent Form
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E.4 | Principal exclusion criteria |
• Children with caries into dentine • A past history of fillings or extractions due to caries • Children with fissure sealants on primary molar teeth • Children with history of severe allergic reactions requiring hospitalisation • Children already participating in any other IMP study at recruitment
• Siblings Rule. Families usually attend the dentist as a unit; therefore a rule is needed to determine the participation of siblings in the trial. The youngest eligible sibling in a family will be randomised and all other eligible siblings will be excluded from the study and receive their NHS dental care in the usual way.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure is to measure the proportion of children that convert from caries free to caries active states. |
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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 | No |
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 | 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 | No |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
Standardised, evidence-based health education |
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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 | 40 |
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 | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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
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The last intervention of the trial is planned for 30.11.2014 and the outcome assessments to be completed by 30.11.2014. However, the study is not due to close until 30.04.2015. This is to allow time to close the databases and complete all analyses. |
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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 | 5 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 29 |