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Clinical Trials/EUCTR2017-002402-13-GB
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

Manchester University NHS Foundation Trust0 sites1,174 target enrollmentNovember 27, 2017

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.

Registry
who.int
Start Date
November 27, 2017
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

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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