Silver Diamine Fluoride Application on Root Caries Fillings
ConditionRoot Caries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorThe University of Hong Kong
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Older adults (aged 60 or above)
At least one untreated decayed dental root
Disqualifiers
No self-care ability for basic daily activities
Teeth with severe decay (cannot be filled)
Teeth indicated for extraction
Trial design
Design model
Parallel
Treatments tested in this trial
SDF solution application
Other interventionsilver 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.
Tonic water
Other interventionTonic water will be used as a placebo to mimic the SDF solution.
Treatment groups
184 Participants
are divided into 2 treatment groupsGroup A: SDF groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Clinical outcome
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
Time frame
24 months follow-upSecondary outcomes
1
Patient-based subjective evaluation
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.
Time frame
24 months follow-upSponsors and contacts
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Source ClinicalTrials.gov