E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Dental caries in high-risk older adults |
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E.1.1.1 | Medical condition in easily understood language |
Tooth decay in high-risk older adults |
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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 | 20.0 |
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 the effect of prescribing 5000ppm fluoride toothpaste with usual care on treatment for caries, including coronal/root restorations, endodontics or extractions
To compare the costs and benefits, within a net benefit framework of prescribing 5000ppm fluoride toothpaste with usual care
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E.2.2 | Secondary objectives of the trial |
Secondary objectives will evaluate the effect of prescribing 5000ppm fluoride toothpaste on caries (mean Decayed Missing Filled Surfaces [DMFS]) increment, progression of early caries lesions, bleeding on probing, quality of life (generic and condition specific), costs to the NHS and to individuals and society, oral health behaviour and episodes of pain. In addition, we will explore the attitudes of clinicians and patients to the prescribing and use of high fluoride toothpaste. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
A more detailed clinical examination undertaken by independent (external to the trial dental practices) dentists will be used to repeat primary outcome measures and collect secondary outcomes (caries increment and bleeding on probing). This more detailed clinical examination will take place in Scottish practices only and the independent examiners will be blind to the allocation. All clinical outcomes will be assessed at baseline and three years by trained examiners. Training will be provided by an expert in caries assessment and the use of criteria in caries clinical trials.
A detailed caries measurement will be made using the validated International Caries Detection and Assessment System (ICDAS) for coronal caries. The ICDAS criteria measure both early and more advanced stages of caries. For early caries, ICDAS measures the surface changes and potential histological depth of carious lesions by relying on surface characteristics related to the optical properties of sound and demineralised enamel prior to cavitation. The primary requirement for applying the ICDAS system is the examination of clean and dry teeth aided by a ball-ended explorer that is used to remove any remaining plaque and debris and to check for surface contour, minor cavitation or sealants. All surfaces of all teeth will be examined and the caries status recorded.
Periodontal Gingival inflammation as bleeding will be measured according to the Gingival Index of Loe by running a UNC periodontal probe circumferentially around each tooth just within the gingival sulcus or pocket. After 30 seconds, bleeding will be recorded as being present or absent on the buccal and lingual surfaces.
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E.3 | Principal inclusion criteria |
• aged 50 years or older • with a diagnosis of active coronal caries (into dentine) in the last 12 months which may\may not have been treated, or any root caries; and\or other risk factors as determined by their GDP. • receive their dental care in part or fully as an NHS patient • living in any residential setting, and • for whom their GDP decides prescription of high concentration fluoride toothpaste is appropriate for the patient
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E.4 | Principal exclusion criteria |
• are currently prescribed (by General Dental Practice or General Practitioner) high concentration fluoride toothpaste (for GDPs prescription must have been issued at last examination visit) • hypersensitivity for Sodium Fluoride and\or other ingredients used in 5000ppm toothpaste • are living in the same household as someone already recruited to Reflect • are unable to provide informed consent |
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of participants receiving any dental treatment due to caries; including restorations, endodontics or extraction. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At 12, 24 and 36 months after commencing treatment |
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E.5.2 | Secondary end point(s) |
Secondary outcomes (patient reported):
• Oral health status using OHIP14, a measure of oral health-related Quality of Life (QoL), collected at baseline and annual follow up through patient administered questionnaires. The OHIP-14 is the most common, validated dental quality of life instrument and has been successfully used in previous HTA trials. It has been found to be sensitive to differences in oral health and is closely correlated with self-reported oral health outcomes.
• The EQ-5D-5L profile measure of generic health status will be collected at baseline and annual follow up through patient questionnaires.
• Any episode of dental pain (and total number per participant) during the 3 year follow up period severe enough to trigger an unscheduled visit to a healthcare profession (dentist, GP, community pharmacist). This will be recorded at scheduled and unscheduled dental visits by patient questionnaire.
• Oral health behaviour, including self-reported brushing/other sources of fluoride. Evaluated at baseline and through annual questionnaires sent by mail to the home address of participants.
Secondary outcomes (clinically assessed): The clinically assessed secondary outcomes will be measured in Scottish practices only. Clinically assessed secondary outcomes are: • Coronal caries increment, including dentist replacement restorations for caries, at tooth surface (DMFS) level by independent, trained and calibrated, clinical examiners at baseline and 3 year (+/- 3 months) follow-up. We will use the ICDAS method to assess caries as it provides flexibility to analyse and present caries data at different diagnostic thresholds. • Root caries increment, including dentist replacement restorations for caries, at tooth surface (DMFRS) level by independent, trained and calibrated, clinical examiners at baseline and 3 year (+/- 3 months) follow-up. • Early caries lesion progression data, using ICDAS. • Bleeding on probing (BoP) will also be recorded by the independent clinical examiners. BoP provides evidence of long term optimal brushing rather than transitory measures such as visible plaque scores.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At 12, 24 and 36 months after commencing treatment (secondary outcomes - patient reported)
At baseline and 36 months (secondary outcomes - clinically assessed (Scottish sub-study)) |
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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 | Yes |
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 | 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 | No |
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 | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 60 |
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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End of trial is defined as end of funding |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 30 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 9 |