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Clinical Trials/ISRCTN11992428
ISRCTN11992428
Active, not recruiting
Phase 3

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

Manchester University NHS Foundation Trust0 sites1,161 target enrollmentJune 2, 2017

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Dental Caries
Sponsor
Manchester University NHS Foundation Trust
Enrollment
1161
Status
Active, not recruiting
Last Updated
3 years ago

Overview

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31126270 protocol (added 29/05/2019)

Registry
who.int
Start Date
June 2, 2017
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Current inclusion criteria as of 15/07/2022:
  • 1\. Patients attending dental practices participating in the trial
  • 2\. Aged 50 years or older
  • 3\. 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
  • 4\. Living in any residential setting
  • 5\. Receive their dental care in part or fully as an NHS patient
  • 6\. Patients whose GDP decides prescription of high concentration fluoride toothpaste is appropriate
  • Previous inclusion criteria:
  • 1\. Patients attending dental practices participating in the trial
  • 2\. Aged 50 years of age or older

Exclusion Criteria

  • Current exclusion criteria as of 15/07/2022:
  • 1\. Currently prescribed (by GDP or GP) high concentration fluoride toothpaste (for GDPs, prescription must have been issued at last examination visit)
  • 2\. Unable to provide informed consent
  • 3\. Hypersensitivity for sodium fluoride and/or other ingredients used in 5000ppm toothpaste
  • 4\. Are living in the same household as someone already recruited to REFLECT, or someone who is routinely using a high concentration fluoride toothpaste
  • Previous exclusion criteria:
  • 1\. Currently prescribed high concentration fluoride toothpaste
  • 2\. Unable to provide informed consent

Outcomes

Primary Outcomes

Not specified

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