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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN30662154
Enrollment
34
Registered
2013-05-17
Start date
2013-05-08
Completion date
Unknown
Last updated
2017-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Oral and Gastrointestinal

Interventions

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

Sponsors

University of Leeds (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Reduction of bacteria in plaque samples; Timepoints: 6 months post treatment

Secondary

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026