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    Summary
    EudraCT Number:2017-002248-34
    Sponsor's Protocol Code Number:FInCH
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-11-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2017-002248-34
    A.3Full title of the trial
    FInCH Study: A randomised feasibility study comparing fluoride interventions to prevent dental decay in older people in care homes.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    FInCH Study: A study comparing the feasibility of fluoride interventions to prevent tooth decay in older people in care homes.
    A.3.2Name or abbreviated title of the trial where available
    FInCH
    A.4.1Sponsor's protocol code numberFInCH
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKing's College London
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNIHR
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London
    B.5.2Functional name of contact pointDr Rakhee Patel
    B.5.3 Address:
    B.5.3.1Street AddressPopulation and Public Health Division. Kings College London Dental Institute. Denmark Hill Campus
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 9RS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4407734862227
    B.5.6E-mailRakhee.patel@kcl.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name DURAPHAT 2800 ppm Fluoride toothpaste
    D.2.1.1.2Name of the Marketing Authorisation holderColgate-Palmolive (U.K.) Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDURAPHAT 2800 ppm Fluoride toothpaste
    D.3.4Pharmaceutical form Toothpaste
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPDental use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFLUORIDE
    D.3.9.3Other descriptive nameSodium Fluoride
    D.3.9.4EV Substance CodeSUB21927
    D.3.10 Strength
    D.3.10.1Concentration unit PPM part per million
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2800
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Duraphat 50 mg/ml Dental Suspension
    D.2.1.1.2Name of the Marketing Authorisation holderColgate-Palmolive (UK.) Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDuraphat 50 mg/ml Dental Suspension
    D.3.4Pharmaceutical form Dental suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPDental use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFLUORIDE
    D.3.9.3Other descriptive nameSodium Fluoride
    D.3.9.4EV Substance CodeSUB21927
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of dental decay in older people in care homes
    E.1.1.1Medical condition in easily understood language
    Prevention of tooth decay in older people in care homes
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10011947
    E.1.2Term Decay dental
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10048297
    E.1.2Term Dental decay
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10044027
    E.1.2Term Tooth decay
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To establish the feasibility, practicability and compliance of fluoride interventions to prevent dental decay in care homes.
    E.2.2Secondary objectives of the trial
    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
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    E.4Principal 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.
    E.5 End points
    E.5.1Primary 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
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months after initiation of treatment
    E.5.2Secondary 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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months after initiation of treatment
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Feasibility
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Assessor blinded
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard fluoride toothpaste 1450ppm
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Database lock
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Residents who are not able to consent themselves will be included if informed consent is provided by residents legal representative. Changes to mental capacity will be assessed at each study visit.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state180
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The programme will be undertaken in care homes in London, where the community dental service currently offers
    dental care. On completion of the project, the dental services will continue to offer dental care to the homes, as is already established. As part of this care, as is usual practice, preventative advice and evidence based fluoride applications will continue to be part of the residents care plan, if they are deemed to require it.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-20
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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