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 | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012318 |
E.1.2 | Term | Dental Caries |
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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 |
The proposed clinical trial will address the following principal research question:
“What is the relative cost and effectiveness of pit and fissure sealants and fluoride varnish in preventing dental decay in the first permanent molar teeth of children”. |
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E.2.2 | Secondary objectives of the trial |
The secondary research objectives are:
• To establish the costs and budget impact of pit and fissure sealants (PFS) and fluoride varnish (FV) delivered in a community/school setting and the relative cost-effectiveness of these technologies • To examine the impact of PFS and FV on children and their parents/carers in terms of quality of life/treatment acceptability measures. • To examine the implementation of treatment in a community setting with respect to the experience of children, parents, schools and clinicians.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Year 2 children, (aged 6-7) years, attending the schools participating in the current Cardiff and Vale UHB Designed to Smile Programme • Children for whom the person with parental responsibility has provided written informed consent • Children with at least one fully-erupted caries-free first permanent molar (determined at baseline examination)
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E.4 | Principal exclusion criteria |
• Children whose medical history precludes inclusion (i.e. those with a history of hospitalisation for asthma, or severe allergies, or allergy to Elastoplast; determined from Medical History Form completed by parents) • Children with known sensitivity to colophony (kolophonium), or any of the product ingredients (e.g. methylacrylate in PFS; determined from Medical History Form completed by parents) • Children with ulcerative gingivitis or stomatitis (determined by clinical examination) • Children with any facial or oral infections e.g. cold sores (determined by clinical examination) • Children with any abnormality of the lips, face or soft tissues of the mouth that would cause discomfort in the provision of PFS/FV (determined by clinical examination) • Children who are showing obvious signs of systemic illness (e.g. colds, ‘flu, chicken pox etc) (determined by clinical examination) • Children currently participating in another clinical trial involving an investigational medicinal product (IMP; determined from Medical History Form completed by parents).
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure will be the development of dental caries on first permanent molars at 36 months. |
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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 | Yes |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Yes |
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 |
health economics; treatment acceptability; process evaluation |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Yes |
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 | Information not present in EudraCT |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Delton Light Curing Pit & Fissure Sealant (Dentsply Ltd; CE0086) |
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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.8.4.1 | 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 | 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 end of the trial is defined as the date of last data capture. This is not the last treatment visit for the child participating in the study as follow-up interviews (face to face or telephone) are required with both the child and parent (as detailed in Section A18). |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |