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Trial registered on ANZCTR


Registration number
ACTRN12616001651471
Ethics application status
Approved
Date submitted
21/11/2016
Date registered
30/11/2016
Date last updated
26/11/2018
Date data sharing statement initially provided
26/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a chlorhexidine-modified filling to treat root decay on cariogenic bacteria in elderly participants: A feasibility study
Scientific title
Effect of a chlorhexidine-modified filling to treat root decay on cariogenic bacteria in elderly participants: A feasibility study
Secondary ID [1] 290148 0
None
Universal Trial Number (UTN)
U1111-1187-2950
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Root caries 300280 0
Condition category
Condition code
Oral and Gastrointestinal 300147 300147 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 295912 0
Treatment: Other
Comparator / control treatment
A tooth on the opposite side of the mouth will be restored with conventional GIC restorative material for comparison, also using the Atraumatic Restorative Technique (ART).
Control group
Active

Outcomes
Primary outcome [1] 299639 0
Cariogenic bacterial load in plaque samples
Timepoint [1] 299639 0
1, 3 and 6 months post treatment
Secondary outcome [1] 327719 0
Cariogenic bacterial load in saliva samples
Timepoint [1] 327719 0
1, 3 and 6 months post treatment
Secondary outcome [2] 327720 0
Survival rate of restorations assessed via visual inspection and dental x-ray
Timepoint [2] 327720 0
6 months post treatment
Secondary outcome [3] 327721 0
Treatment delivery acceptability by patients using a 5-point Likert-type scale
Timepoint [3] 327721 0
Baseline and at 1, 3 and 6 months post treatment

Eligibility
Key inclusion criteria
1. Patients who are 60 yrs 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.
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Power calculations from previous studies (Percival et al., 1991; Marsh et al., 1992; Percival et al., 1994) have demonstrated that the inclusion of 30 participants is sufficient to detect trends or statistically significant changes with 80% power and a Type 1 error rate of 5%. In this study, 4 more participants will be recruited to allow for dropouts or loss to follow up during the trial period. As these are repeated measurements, this pilot study will generate estimates of Intra Class Correlation (ICC) which will then be used to determine the sample size for future clinical trials.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8229 0
New Zealand
State/province [1] 8229 0
Otago

Funding & Sponsors
Funding source category [1] 294526 0
University
Name [1] 294526 0
Faculty of Dentistry, University of Otago
Address [1] 294526 0
310 Great King Street
Dunedin 9016
New Zealand
Country [1] 294526 0
New Zealand
Funding source category [2] 301289 0
Government body
Name [2] 301289 0
Lottery grants board
Address [2] 301289 0
Lottery Grants Board
The Department of Internal Affairs
PO Box 805
Wellington 6140
Country [2] 301289 0
New Zealand
Primary sponsor type
University
Name
Prof. Paul Brunton
Address
Dean of Faculty of Dentistry
University of Otago
310 Great King Street
Dunedin 9016
New Zealand
Country
New Zealand
Secondary sponsor category [1] 293884 0
None
Name [1] 293884 0
None
Address [1] 293884 0
Country [1] 293884 0
Other collaborator category [1] 279225 0
Individual
Name [1] 279225 0
Prof. Karl Lyons
Address [1] 279225 0
University of Otago
2nd Floor, Children’s Pavilion
255 Great King Street
Dunedin 9054
Dental School, Health Sciences
Country [1] 279225 0
New Zealand
Other collaborator category [2] 279326 0
Individual
Name [2] 279326 0
Mr. Hassan Mohamed Ahmed
Address [2] 279326 0
Faculty of Dentistry
University of Otago
310 Great King Street
Dunedin 9016
New Zealand
Country [2] 279326 0
New Zealand
Other collaborator category [3] 279327 0
Individual
Name [3] 279327 0
Dr Carolina Loch
Address [3] 279327 0
Faculty of Dentistry
University of Otago
310 Great King Street
Dunedin 9016
New Zealand
Country [3] 279327 0
New Zealand
Other collaborator category [4] 279872 0
Individual
Name [4] 279872 0
Dr Jithendra Ratnayake
Address [4] 279872 0
Sir John Walsh Research Institute
71 Frederick Street
North Dunedin
Dunedin 9016
Country [4] 279872 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295959 0
Health and DIsability Ethics Committees
Ethics committee address [1] 295959 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 295959 0
New Zealand
Date submitted for ethics approval [1] 295959 0
08/11/2016
Approval date [1] 295959 0
18/11/2016
Ethics approval number [1] 295959 0
16/CEN/174

Summary
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.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1242 1242 0 0
Attachments [2] 1243 1243 0 0
Attachments [3] 1244 1244 0 0

Contacts
Principal investigator
Name 69034 0
Prof Paul Brunton
Address 69034 0
Faculty of Dentistry, University of Otago
310 Great King Street
Dunedin 9054
PO Box 647
Country 69034 0
New Zealand
Phone 69034 0
+6434797039
Fax 69034 0
Email 69034 0
paul.brunton@otago.ac.nz
Contact person for public queries
Name 69035 0
Prof Paul Brunton
Address 69035 0
Faculty of Dentistry, University of Otago
310 Great King Street
Dunedin 9054
PO Box 647
Country 69035 0
New Zealand
Phone 69035 0
+6434797039
Fax 69035 0
Email 69035 0
paul.brunton@otago.ac.nz
Contact person for scientific queries
Name 69036 0
Prof Paul Brunton
Address 69036 0
Faculty of Dentistry, University of Otago
310 Great King Street
Dunedin 9054
PO Box 647
Country 69036 0
New Zealand
Phone 69036 0
+6434797039
Fax 69036 0
Email 69036 0
paul.brunton@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data obtained for this study will be confidential
What supporting documents are/will be available?
Study protocol
Ethical approval
How or where can supporting documents be obtained?
Type [1] 461 0
Ethical approval
Citation [1] 461 0
Link [1] 461 0
Email [1] 461 0
Other [1] 461 0
Type [2] 462 0
Study protocol
Citation [2] 462 0
Link [2] 462 0
Email [2] 462 0
Other [2] 462 0
Summary results
No Results