Atraumatic restorative treatment for caries in the elderly - A study to assess a novel approach for the prevention of root caries

ISRCTN	ISRCTN30662154
DOI	https://doi.org/10.1186/ISRCTN30662154
Secondary identifying numbers	14230

Submission date: 17/05/2013
Registration date: 17/05/2013
Last edited: 06/01/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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?
Gillian Dukanovic
g.dukanovic@leeds.ac.uk

Contact information

Prof Paul Brunton
Scientific

Leeds Dental Institute
Clarendon Way
Leeds
LS2 9LU
United Kingdom

Phone	+44 113 343 6182
Email	p.a.brunton@leeds.ac.uk

Study information

Study design	Non-randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	ARTCARE
Study objectives	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).
Ethics approval(s)	NRES Committee Yorkshire & The Humber - Leeds West, 22/02/2013, ref: 13/YH/0010
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	08/05/2013
Completion date	08/08/2014

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	UK Sample Size: 34
Key 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.
Key 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.
Date of first enrolment	08/05/2013
Date of final enrolment	08/08/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Leeds Dental Institute

Leeds
LS2 9LU
United Kingdom

Sponsor information

University of Leeds (UK)
University/education

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

Website	http://www.leeds.ac.uk/
"ROR"	https://ror.org/024mrxd33

Funders

Funder type

Charity

Dunhill Medical Trust (UK) Grant Codes: R245/0212
Private sector organisation / Other non-profit organizations

Alternative name(s): The Dunhill Medical Trust, DMT
Location: United Kingdom

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?
HRA research summary			28/06/2023	No	No

Editorial Notes

06/01/2017: No publications found in PubMed, verifying study status with principal investigator.