FInCH Study: A randomised feasibility study comparing fluoride interventions to prevent dental decay in older people in care homes.

INTERVENTION: Trade Name: DURAPHAT 2800 ppm Fluoride toothpaste Product Name: DURAPHAT 2800 ppm Fluoride toothpaste Pharmaceutical Form: Toothpaste INN or Proposed INN: FLUORIDE Other descriptive name: Sodium Fluoride Concentration unit: PPM part per million Concentration type: equal Concentration number: 2800‐ Trade Name: Duraphat 50 mg/ml Dental Suspension Product Name: Duraphat 50 mg/ml Dental Suspension Pharmaceutical Form: Dental suspension INN or Proposed INN: FLUORIDE Other descriptive name: Sodium Fluoride Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50‐ CONDITION: Prevention of dental decay in older people in care homes ; MedDRA version: 20.0 Level: LLT Classification code 10011947 Term: Decay dental System Organ Class: 100000004856 ; MedDRA version: 20.0 Level: LLT Classification code 10048297 Term: Dental decay System Organ Class: 100000004856 ; MedDRA version: 20.0 Level: LLT Classification code 10044027 Term: Tooth decay System Organ Class: 100000004856 Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Dentistry [E06] PRIMARY OUTCOME: Main Objective: To establish the feasibility, practicability and compliance of fluoride interventions to prevent dental decay in care homes. Primary end point(s): Feasibility Outcomes: ; • Number of participants recruited, retained, consented and lost (drop out) through the trial period in each trial arm.; ; • Compliance to trial and data collection process by number of examinations completed, mean length of examination, changes in the level of supportive need (as measured by the indicator of relative need tool ‘IoRN’) through the trial period in each trial arm. ; ; • Fidelity to the trial processes: ; Number of time teeth brushed with fluoride toothpaste in all arms; Weight of toothpaste tubes monthly; Number of applications of fluoride varnish per participant in varnish arm; Secondary Objective: 1. To estimate the effects of 3 different fluoride treatments in the prevention of dental decay in older people residing in care homes. ; 2. To provide preliminary data on the economic value of the three interventions to the patient or NHS payer; Timepoint(s) of evaluation of this end point: 12 months after initiation of treatment SECONDARY OUTCOME: Secondary end point(s): Efficacy Outcomes: Estimation of Clinical Benefit (effect size) ; • Number and proportion of teeth with decay progression at tooth surface level between trial arms ; • Number of teeth with decay arrest at tooth surface level ; • Number of teeth with no change in decay at surface level ; ; Economic Outcomes: ; The following outcomes will provide preliminary evidence for the cost‐effectiveness of the intervention ; • Use of health resources relating to dental care (general dental or medical practitioner visits, domiciliary care visits, out of hours’ emergency dental center visits) for the intervention year versus the year preceding the study collected from residents care records ; • Use of health resources for delivery of the intervention (dental team hours, resources, medicinal products) from data collection forms completed by dental team. ; • Use of resources in the home (carers time, administrative hours) from data collection forms completed by care team ; • Compare the above areas between the trial arms. ; Timepoint(s) of evaluation of this end point: 12 months after initiation of treatment INCLUSION CRITERIA: 1. Residents (male or female) over 65 years residing in one of the enlisted care homes 2. Residents with at least 5 natural teeth or roots 3. Provision of written informed consent by the resident or residents legal representative Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 180