An interventional study of SDF solution application and Tonic water in Root Caries, sponsored by The University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-12-09.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment
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
Participants will be allocated into two group
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
Hypotheses to be tested:
39 studies on the registry are indexed under Root Caries; 14 are open to participants now.
This study's planned enrollment of 184 is above the median of 62 across 35 interventional studies indexed under Root Caries.
Browse Root Caries studies →The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Participants of SDF group will be applied with SDF before placement of root caries restoration
Other: SDF solution application
Participants of control group will be applied with placebo (tonic water) before placement of root caries restoration
Other: Tonic water
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.
Tonic water will be used as a placebo to mimic the SDF solution.
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-up
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-up
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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