Root Caries
Conditions
Keywords
silver diamine fluoride, older adults, restorative treatment, root caries
Brief summary
The goal of this clinical trial is to learn the influence of prior silver diamine fluoride (SDF) application on root caries fillings. The main questions to answer 1. Compare the success of fillings placed in dental root decay that have prior SDF application and those without prior SDF application; 2. Compare patient-based subjective evaluations on the two approaches mentioned above in treating root caries. Participants will be allocated into two group 1. prior SDF application before receiving root caries fillings 2. directly receiving root caries fillings without any SDF application
Detailed description
The aim of the proposed study is to investigate the influence of prior SDF application on the restorative treatment of root caries. The objectives of the study are to 1. Compare the success rate of restorations placed in root caries lesions that have prior SDF application and that of restorations placed without prior SDF application; 2. Compare patient-based subjective evaluations on the two different approaches mentioned-above in treating root caries lesions. Hypotheses to be tested: 1. Prior SDF application increases the success rate of restorations placed in root caries; 2. Patient-based subjective evaluations of the treatment outcomes are better when SDF is applied to the root caries lesions prior to restoring the lesions.
Interventions
OTHERSDF solution application
silver diamine fluoride (SDF) solution is highly effective in stopping and arresting the progress of decay in dental roots of older adults. The American Dental Association (ADA) has published a guideline based on the up-to-date evidence to support the use of SDF for managing tooth decay. As a non-invasive procedure, application of SDF is simple, quick, painless and non-aerosol generated.
OTHERTonic water
Tonic water will be used as a placebo to mimic the SDF solution.
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Participants, operators and investigators will not be informed of the group allocation
Intervention model description
two-arm randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Older adults (aged 60 or above) * At least one untreated decayed dental root
Exclusion criteria
* No self-care ability for basic daily activities * Teeth with severe decay (cannot be filled) * Teeth indicated for extraction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcome | 24 months follow-up | Compare the success rate of restorations placed in root caries lesions that have prior SDF application or that of restorations placed without prior SDF application |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-based subjective evaluation | 24 months follow-up | Compare patient-based subjective evaluations on the two different approaches in treating root caries lesions. The Chinese version of General Oral Health Assessment Index (GOHAI) will be adopted as a tool to assess the oral health-related quality of life (OHRQoL) of the participants. It contains 12 questions covering three domains: physical function, pain and discomfort, and psychosocial function. The total GOHAI score is generated by adding up the score of each response to the 12 questions, and the total score ranges from 12 to 60. A higher score indicates a better perceived OHRQoL. |
Countries
Hong Kong
Outcome results
None listed