A Randomised controlled trial to Evaluate the effectiveness and cost benefit of prescribing high dose FLuoride toothpaste in preventing and treating dEntal Caries in high-risk older adulTs (REFLECT trial) - REFLECT

Phase 1

• Conditions: Dental caries in high-risk older adults; MedDRA version: 20.0 Level: PT Classification code 10012318 Term: Dental caries System Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2017-002402-13-GB
• Lead Sponsor: Manchester University NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-27
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 1174

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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 587
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 587

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified