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

Not Applicable

Completed

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

Registration Number: ISRCTN30662154

Lead Sponsor: niversity of Leeds (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 34

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.

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of bacteria in plaque samples; Timepoints: 6 months post treatment

Secondary Outcome Measures

Name	Time	Method
1. Reduction of bacteria in plaque samples; Timepoints: 1 and 3 months post treatment<br>2. Reduction of bacteria in saliva samples; Timepoints: 1 and 3 month post treatment<br>3. Reduction of bacteria in saliva samples; Timepoints: 6 months post treatment<br>4. Survival rate of restorations; Timepoints: 6 months post treatment<br>5. Treatment delivery acceptability by dental therapists; Timepoints: Baseine, and at 1, 3 and 6 months post treatment<br>6. Treatment delivery acceptability by patients; Timepoints: Baseline and at 1, 3 and 6 months post treatment