A randomised controlled trial to evaluate the cost effectiveness of prescribing high concentration fluoride toothpaste to prevent tooth decay in older adults

Phase 3

Active, not recruiting

• Conditions: Dental Caries; Oral Health

• Registration Number: ISRCTN11992428
• Lead Sponsor: Manchester University NHS Foundation Trust

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-02
• Last Update Posted: 15 August 2022
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1161

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
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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measure as of 15/07/2022:<br> Restoration or extraction or endodontic treatment due to dental caries (dichotomous outcome yes/no) will be recorded at scheduled and unscheduled dental visits on the Case Report Form (CRF) completed by PIs at each site on a rolling basis during the 3-year follow-up period<br><br> _____<br><br> Previous primary outcome measure:<br> Restoration or extraction due to dental caries (dichotomous outcome yes/no) will be recorded at scheduled and unscheduled dental visits on the Case Report Form (CRF) completed by PIs at each site on a rolling basis during the 3 year follow up period.<br>