Dental Caries Oral Health Dental Caries
Conditions
Interventions
Current intervention as of 15/07/2022:
Eligible and consenting participants will be randomised to one of the two intervention groups using the web-based application, both hosted by the
Sponsors
Manchester University NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 15/07/2022: 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 _____ Previous primary outcome measure: 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 15/07/2022: Clinical: 1. Coronal and root caries increment , including dentist replacement fillings for caries, at tooth surface (DMFS) level is assessed using the ICDAS method to assess caries as it provides flexibility to analyse and present caries data at different diagnostic thresholds at baseline and 3 year (+/- 3 months) follow-up. This will also be used for collecting early caries lesion progression data (DMFS measured in Scottish practices only). 2. Early caries lesion progression data is measured using ICDAS (in Scottish practices only) at baseline and 3 year (+/- 3 months) follow-up 3. Bleeding on probing (BoP) will be recorded by the independent clinical examiners (in Scottish practices only) at baseline and 3 year (+/- 3 months) follow-up Patient: 1. Oral health status using OHIP14, a measure of oral health-related Quality of Life (QoL), collected at baseline and annual follow up over the 3 year follow up period through patient administered questionnaires 2. The EQ-5D-5L profile measure of generic health status will be collected at baseline and annual follow up through patient questionnaires over the 3 year follow up period 3. Episodes of dental pain (number and an assessment of severity using a visual analogue scale) will be recorded at scheduled and unscheduled dental visits on the CRF. In addition questions about dental pain experience will be included in annual questionnaires sent to participants. 4. Oral health behaviour, including self-reported brushing/other sources of fluoride. Evaluated at baseline and through annual questionnaires sent to participants over the 3-year follow-up period of the trial Economic: 1. Provision of NHS dental treatments will be collected using the CRF completed at each visit and by routinely collected data | — |
Countries
England, Northern Ireland, Scotland, United Kingdom
Contacts
Public ContactJanet Clarkson
Outcome results
None listed