E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Mouth and tooth diseases [C07] |
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 |
Does Duraphat® fluoride varnish applied in addition to usual treatment provide additional protection against dental decay in children attending nursery school? Dental decay is measured by the d3mft score, based on the number of decayed (i.e. decay into the tooth dentine), missing or filled teeth. This score will be compared at baseline and 2 years later. |
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E.2.2 | Secondary objectives of the trial |
1. absolute change in d3mft at two years of follow up minus the d3mft at baseline. 2. occurrence of any increase in the individual score components (i.e. decayed, filled and missing teeth analysed separately), 3. absolute change in d3mfs (surfaces) at two years of follow up minus the d3mfs at baseline,
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Attendance at a Local Authority nursery school or class as a ante pre-school attendee (entry after third birthday).
2. Participating nurseries will serve significant numbers of children whose home postcode is within the most deprived quintile of postcodes as measured by the Scottish Index of Multiple Deprivation. Every eligible child in participating nurseries will be invited to join the study, irrespective of the SIMD ranking of their own postcode.
3. Children with or without pre-existing cavities are included, as the cavity can be treated through the usual primary care dental service (ie as part of ‘treatment as usual’).
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E.4 | Principal exclusion criteria |
• Children with contraindications for Duraphat varnish i.e. hypersensitivity to colophony and/or any other constituents, ulcerative gingivitis, stomatitis, bronchial asthma, history of allergic episodes requiring hospital admission (eg for asthma).
2. Receipt of fluoride supplements, due to a small risk of fluorosis.
3. Abnormalities of the skin around the mouth, lips (e.g. cold sores) and soft tissue lesions.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint for each individual child is whether or not there has been any occurrence of new caries lesions over the two year period, as measured by any increase in d3mft at two years of follow up compared to the d3mft score at baseline. D3mft score = number of teeth with decay in the dentine, plus number of teeth missing or filled). The baseline and end of study scores will be compared for the intervention and control groups. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At baseline and baseline plus 24 months, when the children are in the first year of primary school. |
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E.5.2 | Secondary end point(s) |
Absolute change in d3mft at two years of follow up minus the d3mft at baseline;
Absolute change in d3mfs (ie (number of tooth surfaces with decay in the dentine, plus number of teeth missing or filled) at two years of follow up minus the d3mfs at baseline.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At baseline and baseline plus 24 months, when the children are in the first year of primary school. |
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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 | 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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
treatment as usual, including preventive care |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 2 |
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 | 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
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Last visit of the last 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 | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 27 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 27 |