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ISRCTN
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ISRCTN99286964
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ClinicalTrials.gov identifier
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Public title
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Anti-microbial varnish in the management of root caries in mentally and/or medically compromised older adults
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Scientific title
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Acronym
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N/A
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Serial number at source
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REC00054
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Study hypothesis
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Root caries is an increasing clinical problem affecting some 80 per cent of dentate elderly and especially those in residential homes and the house-bound. Root caries develops in older adults as the gingival tissues recede to expose the root surface and bacteria accumulate as the gingival margin. The measurement of root caries is difficult due to the high organic content of the root dentine, the proximity of the lesion to the gingival margin and the difficulty in gaining access to the disease in patients who may be frail and elderly or who give only limited co-operation with the treatment. The development of novel anti-microbial treatment regimens, in combination with conventional topical fluoride, may enable the development of new management protocols for the treatment of existing root carious lesions and for the prevention of new lesions.
We propose to determine, in a double-blind placebo controlled trial, the effects of a antimicrobial varnish containing chlorhexidine and thymol in conjunction with a remineralising, fluoride-containing varnish on clinical and microbiological parameters of root carious lesions. The control procedure will consist of the fluoride varnish and a placebo varnish in place of the chlorhexidine-thymol varnish. This project may demonstrate a new, non-restorative means of managing root carious lesions in institutionalised and home-bound individuals which would be more readily accepted by the patient and enable the practitioner to manage root caries more cheaply and more efficiently.
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Lay summary
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Ethics approval
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Approved by local medical ethics committee
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Study design
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Double blind longitudinal randomised placebo controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Root caries
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Participants - inclusion criteria
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1. 150 elderly frail patients
2. Minimum of four teeth
3. At least one root caries lesion
4. Amenable to dental examination
5. Expected to survive the length of the study
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Participants - exclusion criteria
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Antibiotics less than four weeks ago.
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Anticipated start date
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01/04/1997
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Anticipated end date
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01/04/1999
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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150
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Interventions
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1. Use of antimicrobial varnish containing chlorhexidine and thymol in conjunction with a remineralising, fluoride-containing varnish on clinical and microbiological parameters of root carious lesions.
2. The control procedure will consist of the fluoride varnish and a placebo varnish in place of the chlorhexidine-thymol varnish.
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Primary outcome measure(s)
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1. Effect on the salivary flora
2. Changes in clinical status
3. Dimensions of root lesions
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NHS Executive London (UK)
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Trial website
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Publications
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2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12554113
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Contact name
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Dr
David
Beighton
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Address
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King's College School of Medicine & Dentistry
Joint Microbiology Research Unit
Faculty of Clinical Dentistry
Denmark Hill
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City/town
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London
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Zip/Postcode
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SE5 9RW
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Country
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United Kingdom
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Tel
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+44 (0)20 73463272
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Email
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david.beighton@kcl.ac.uk
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Sponsor
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NHS R&D Regional Programme Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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26/08/2010
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Date ISRCTN assigned
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23/01/2004
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