FInCH Study: A study comparing the feasibility of fluoride interventions to prevent tooth decay in older people in care homes.

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002248-34-GB

Enrollment

180

Registered

2017-11-07

Start date

2018-02-20

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of dental decay in older people in care homes MedDRA version: 20.1 Level: LLT Classification code 10011947 Term: Decay dental System Organ Class: 100000004856 MedDRA version: 20.1 Level: LLT Classification code 10048297 Term: Dental decay System Organ Class: 100000004856 MedDRA version: 20.1

Interventions

Trade Name: DURAPHAT 2800 ppm Fluoride toothpaste Product Name: DURAPHAT 2800 ppm Fluoride toothpaste Pharmaceutical Form: Toothpaste INN or Proposed IN

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Exclusion Criteria 1. Residents who are not able to consent themselves, and have no registered legal representative and therefore valid consent cannot be sought 2. Hypersensitivity to the active substance, colophony or to any of the excipients of the IMP or comparators 3. History of active ulcerative gingivitis, active stomatitis and bronchial asthma. 4. Residents with facial or oral infections e.g. Cold sores or draining sinus. 5. Residents at the care home on end of life care 6. Females of childbearing potential. Fluoride varnish is contraindicated to pregnant women therefore all female participants will need to be at least one year post-menopausal.

Design outcomes

Primary

Measure	Time frame
Main Objective: To establish the feasibility, practicability and compliance of fluoride interventions to prevent dental decay in care homes. ; 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 ; 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 ;Timepoint(s) of evaluation of this end point: 12 months after initiation of treatment	—

Measure

Time frame

Main Objective: To establish the feasibility, practicability and compliance of fluoride interventions to prevent dental decay in care homes. ; 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 ; 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 ;Timepoint(s) of evaluation of this end point: 12 months after initiation of treatment

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

United Kingdom

Contacts

Public ContactDr Rakhee Patel

King's College London

Rakhee.patel@kcl.ac.uk+4407734862227

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026