E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of dental decay in older people in care homes |
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E.1.1.1 | Medical condition in easily understood language |
Prevention of tooth decay in older people in care homes |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011947 |
E.1.2 | Term | Decay dental |
E.1.2 | System Organ Class | 100000004856 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048297 |
E.1.2 | Term | Dental decay |
E.1.2 | System Organ Class | 100000004856 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10044027 |
E.1.2 | Term | Tooth decay |
E.1.2 | System Organ Class | 100000004856 |
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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 establish the feasibility, practicability and compliance of fluoride interventions to prevent dental decay in care homes. |
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E.2.2 | Secondary objectives of the trial |
1. To estimate the effects of 3 different fluoride treatments in the prevention of dental decay in older people residing in care homes.
2. To provide preliminary data on the economic value of the three interventions to the patient or NHS payer
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Residents (male or female) over 65 years residing in one of the enlisted care homes
2. Residents with at least 5 natural teeth or roots
3. Provision of written informed consent by the resident or residents legal representative
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E.4 | Principal exclusion criteria |
Exclusion Criteria
1. Residents who are not able to consent themselves, and have no registered legal representative and therefore valid consent cannot be sought
2. Hypersensitivity to the active substance, colophony or to any of the excipients of the IMP or comparators
3. History of active ulcerative gingivitis, active stomatitis and bronchial asthma.
4. Residents with facial or oral infections e.g. Cold sores or draining sinus.
5. Residents at the care home on end of life care
6. Females of childbearing potential. Fluoride varnish is contraindicated to pregnant women therefore all female participants will need to be at least one year post-menopausal. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Feasibility Outcomes:
• Number of participants recruited, retained, consented and lost (drop out) through the trial period in each trial arm.
• Compliance to trial and data collection process by number of examinations completed, mean length of examination, changes in the level of supportive need (as measured by the indicator of relative need tool ‘IoRN’) through the trial period in each trial arm.
• Fidelity to the trial processes:
Number of time teeth brushed with fluoride toothpaste in all arms
Weight of toothpaste tubes monthly
Number of applications of fluoride varnish per participant in varnish arm
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 months after initiation of treatment |
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E.5.2 | Secondary end point(s) |
Efficacy Outcomes: Estimation of Clinical Benefit (effect size)
• Number and proportion of teeth with decay progression at tooth surface level between trial arms
• Number of teeth with decay arrest at tooth surface level
• Number of teeth with no change in decay at surface level
Economic Outcomes:
The following outcomes will provide preliminary evidence for the cost-effectiveness of the intervention
• Use of health resources relating to dental care (general dental or medical practitioner visits, domiciliary care visits, out of hours’ emergency dental center visits) for the intervention year versus the year preceding the study collected from residents care records
• Use of health resources for delivery of the intervention (dental team hours, resources, medicinal products) from data collection forms completed by dental team.
• Use of resources in the home (carers time, administrative hours) from data collection forms completed by care team
• Compare the above areas between the trial arms.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
12 months after initiation of treatment |
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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 | No |
E.6.4 | Safety | No |
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 | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | 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 | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Standard fluoride toothpaste 1450ppm |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
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.8.5 | 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 1 |