Contact information
Type
Scientific
Primary contact
Dr David Beighton
ORCID ID
Contact details
King's College School of Medicine & Dentistry
Joint Microbiology Research Unit
Faculty of Clinical Dentistry
Denmark Hill
London
SE5 9RW
United Kingdom
+44 (0)20 73463272
david.beighton@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
REC00054
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Approved by local medical ethics committee
Study design
Double blind longitudinal randomised placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Root caries
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Chlorhexidine and thymol in a remineralising, fluoride-containing varnish
Primary outcome measure
1. Effect on the salivary flora
2. Changes in clinical status
3. Dimensions of root lesions
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/1997
Overall trial end date
01/04/1999
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
150
Participant exclusion criteria
Antibiotics less than four weeks ago.
Recruitment start date
01/04/1997
Recruitment end date
01/04/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College School of Medicine & Dentistry
London
SE5 9RW
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive London (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12554113
Publication citations
-
Results
Brailsford SR, Fiske J, Gilbert S, Clark D, Beighton D, The effects of the combination of chlorhexidine/thymol- and fluoride-containing varnishes on the severity of root caries lesions in frail institutionalised elderly people., J Dent, 30, 7-8, 319-324.