Condition category
Oral Health
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
26/08/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12554113

Publication citations

  1. 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.

Additional files

Editorial Notes