Plain English Summary
Background and study aims
The aim of the study is to see how well tooth decay in elderly patients can be treated using a dental material (containing Chlorhexidine, which is commonly found in mouthwashes) when applied using a simple and painless method called Atraumatic Restorative Treatment. This is important because the elderly population are at a high risk of developing cavities (holes) in their teeth near the gum surface (called root caries).
Who can participate?
Adults aged 60 years or older, with at least one tooth with root caries that requires treatment.
What does the study involve?
Participants will be seen at a screening assessment to confirm that they are suitable to take part. Participants will then be invited for a treatment visit where photographs, plaque and saliva samples will be taken and the root caries treated with the dental material. Saliva and plaque samples will be collected at 1, 3 and 6 months and photographs taken at 6 months. Questionnaires will be completed at all visits.
What are the possible benefits and risks of participating?
Chlorhexidine is used safely in toothpastes and mouthwashes, so very few side effects are expected. The way the treatment is applied is likely to be simple and painless compared with conventional dental fillings. However additional visits are needed in order to collect plaque and saliva samples.
Where is the study run from?
Leeds Dental Institutes Dental Translational and Clinical Research Unit (DenTCRU), Leeds, UK
When is the study starting and how long is it expected to run for?
May 2013 - August 2014
Who is funding the study?
Dunhill Medical Trust
Who is the main contact?
Prof Paul Brunton
Leeds Dental Institute
Atraumatic Restorative Treatment for CARies in the Elderly - A pilot non-randomised study to assess a novel approach for the prevention of root caries
The aim of this pilot study is to see how well tooth decay in elderly patients can be treated using a glass ionomer cement (GIC) dental material containing chlorhexidine (CHX) (which is commonly found in mouthwashes) when applied by dental therapists using the simple and painless method, Atraumatic Restorative Treatment (ART). This is important because the elderly population are at a high risk of developing cavities (holes) in their teeth near the gum surface (called root caries).
This study aims to examine the effect of using GIC containing CHX on the levels of bacteria present in the mouths of elderly patients with at least one small root caries requiring operative intervention. The lesion will be treated once using the ART technique and the GIC containing CHX will be applied. The patient will be asked to return to the clinic on four occasions over a 6 month period where plaque and saliva samples will be collected at each visit. These samples will be analysed to determine the quantity and types of bacterial species that are present. Each patient will act as their own control where changes in the levels of bacteria in the plaque sample will be compared before and after administration of ART. Patients and dental therapists will be asked at every visit for their opinion of the ART technique and how their treated tooth has been feeling. The primary measure of success will be the reduction in bacteria present in the plaque samples at 6 months after the ART treatment has been performed.
Patients will also be asked to provide their consent to allow the material removed from their affected tooth during the ART process and the plaque sample from a healthy tooth to be used in future studies for genetic analysis of the bacteria themselves.
More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=14230
NRES Committee Yorkshire & The Humber - Leeds West, date of approval 22/2/13, ref: 13/YH/0010
Non-randomised interventional treatment trial
Primary study design
Secondary study design
Non randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Topic: Oral and Gastrointestinal; Subtopic: Oral and Gastrointestinal (all Subtopics); Disease: Oral & Dental
GIC modified with chlorhexidine.
GIC with 5% chlorhexidine, applied once and left in place.
Primary outcome measures
Reduction of bacteria in plaque samples; Timepoints: 6 months post treatment
Secondary outcome measures
1. Reduction of bacteria in plaque samples; Timepoints: 1 and 3 months post treatment
2. Reduction of bacteria in saliva samples; Timepoints: 1 and 3 month post treatment
3. Reduction of bacteria in saliva samples; Timepoints: 6 months post treatment
4. Survival rate of restorations; Timepoints: 6 months post treatment
5. Treatment delivery acceptability by dental therapists; Timepoints: Baseine, and at 1, 3 and 6 months post treatment
6. Treatment delivery acceptability by patients; Timepoints: Baseline and at 1, 3 and 6 months post treatment
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Patients will be >=60 yrs (females and males)
2. Patients will have at least one lesion of root caries, which requires operative intervention.
3. Patients who are willingly to provide signed informed consent.
4. Patients who are willing to follow the research schedule for the period of the study.
Target number of participants
UK Sample Size: 34
Participant exclusion criteria
1. Patients with no natural teeth.
2. Patients currently having antibiotic therapy or within 4 weeks of completion of a course of therapy with antibiotics.
3. Patients who are currently receiving or who have had radiotherapy of the head and neck region within the last 12 months.
4. Patients who are currently using or who have used toothpastes and/or mouthwashes containing chlorhexidine within the last 4 weeks.
5. Patients who have active periodontal disease which is likely to require treatment such as root surface debridement (RSD) during the study.
6. Patients who have any condition (including an allergy to chlorhexidine) which could be expected to interfere with the patients safety during the study.
7. Patients who demonstrate an inability to comply with study procedures.
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Leeds Dental Institute
University of Leeds (UK)
Faculty Research Office
University of Leeds
Level 10 Worsley Building
Dunhill Medical Trust (UK) Grant Codes: R245/0212
Funding Body Type
private sector organisation
Funding Body Subtype
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