Condition category
Oral Health
Date applied
17/05/2013
Date assigned
17/05/2013
Last edited
10/06/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 Institute’s 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?
Gillian Dukanovic
g.dukanovic@leeds.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Paul Brunton

ORCID ID

Contact details

Leeds Dental Institute
Clarendon Way
Leeds
LS2 9LU
United Kingdom
p.a.brunton@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14230

Study information

Scientific title

Atraumatic Restorative Treatment for CARies in the Elderly - A pilot non-randomised study to assess a novel approach for the prevention of root caries

Acronym

ARTCARE

Study hypothesis

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

Ethics approval

NRES Committee Yorkshire & The Humber - Leeds West, date of approval 22/2/13, ref: 13/YH/0010

Study design

Non-randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Oral and Gastrointestinal; Subtopic: Oral and Gastrointestinal (all Subtopics); Disease: Oral & Dental

Intervention

GIC modified with chlorhexidine.

GIC with 5% chlorhexidine, applied once and left in place.

Intervention type

Other

Phase

Not Applicable

Drug names

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

08/05/2013

Overall trial end date

08/08/2014

Reason abandoned

Eligibility

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.

Participant type

Patient

Age group

Senior

Gender

Both

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 patient’s safety during the study.
7. Patients who demonstrate an inability to comply with study procedures.

Recruitment start date

08/05/2013

Recruitment end date

08/08/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leeds Dental Institute
Leeds
LS2 9LU
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

Faculty Research Office
University of Leeds
Room 10.110
Level 10 Worsley Building
Clarendon Way
Leeds
LS2 9NL
United Kingdom

Sponsor type

University/education

Website

http://www.leeds.ac.uk/

Funders

Funder type

Charity

Funder name

Dunhill Medical Trust (UK) Grant Codes: R245/0212

Alternative name(s)

DMT

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes