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Effect of a chlorhexidine-modified filling to treat root decay on cariogenic bacteria in elderly participants: A feasibility study

Effect of a chlorhexidine-modified filling to treat root decay on cariogenic bacteria in elderly participants: A feasibility study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001651471
Enrollment
26
Registered
2016-11-30
Start date
2017-02-23
Completion date
2020-05-12
Last updated
2021-12-27

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

Conditions

None listed

Brief summary

Increasingly, elderly people are retaining natural teeth but their oral hygiene and dental care needs are often neglected. A major problem the elderly face is the high frequency of root caries. Strategies to render root surfaces less susceptible to microbial colonization and decay have not had long-lasting effects and a simple treatment appropriate to those with reduced function to arrest root caries in the long term is not available. Glass-ionomer cements (GIC) are effective against cariogenic bacteria in children and on root surfaces in vitro. We have modified GIC with chlorhexidine (GIC-CHX) to deliver greater and longer lasting antiplaque activity. In this pilot study, we propose to investigate the effectiveness of modified GIC to elderly patients with root surface caries when applied using a relatively non-invasive approach (Atraumatic Restorative Treatment, ART), facilitating subsequent investigations of applying ART on a domiciliary basis to elderly people in care homes or housebound.

Interventions

One tooth with root caries will be restored with 5% chlorhexidine-modified glass-ionomer cement (GIC) restorative material applied using the Atraumatic Restorative Technique (ART). ART only uses hand instruments to clean the cavity and place the restoration. No drilling or local anaesthetic is required. The procedure is expected to take 30-45 min. A clinician with 9 years of experience will be placing the restorations. Intervention will take place at the Faculty of Dentistry, University of Otago

One tooth with root caries will be restored with 5% chlorhexidine-modified glass-ionomer cement (GIC) restorative material applied using the Atraumatic Restorative Technique (ART). ART only uses hand instruments to clean the cavity and place the restoration. No drilling or local anaesthetic is required. The procedure is expected to take 30-45 min. A clinician with 9 years of experience will be placing the restorations. Intervention will take place at the Faculty of Dentistry, University of Otago.

Sponsors

Prof. Paul Brunton
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients who are 18 years and older (females and males) 2. Patients who are partially or fully dentate 3. Patients who have at least two root caries lesions which requires operative intervention. 4. Patients who are willingly to provide signed informed consent. 5. Patients who are willing to follow the research schedule for the period of the study. who are

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026