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 |
| Secondary identifying numbers | REC00054 |
- 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
| Study design | Double blind longitudinal randomised placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/04/1997 |
| Completion date | 01/04/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
King's College School of Medicine & Dentistry
London
SE5 9RW
United Kingdom
SE5 9RW
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive London (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
