Anti-microbial varnish in the management of root caries in mentally and/or medically compromised older adults
| ISRCTN | ISRCTN99286964 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99286964 |
| Protocol serial number | REC00054 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive London (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 26/08/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr David Beighton
Scientific
Scientific
King's College School of Medicine & Dentistry
Joint Microbiology Research Unit
Faculty of Clinical Dentistry
Denmark Hill
London
SE5 9RW
United Kingdom
| Phone | +44 (0)20 73463272 |
|---|---|
| david.beighton@kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double blind longitudinal randomised placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Approved by local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Chlorhexidine and thymol in a remineralising, fluoride-containing varnish |
| Primary outcome measure(s) |
1. Effect on the salivary flora |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/04/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 150 |
| Key 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 |
| Key exclusion criteria | Antibiotics less than four weeks ago. |
| Date of first enrolment | 01/04/1997 |
| Date of final enrolment | 01/04/1999 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
King's College School of Medicine & Dentistry
London
SE5 9RW
United Kingdom
SE5 9RW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2002 | Yes | No |
