EUCTR2017-002402-13-GB
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Manchester University NHS Foundation Trust
- Enrollment
- 1174
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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