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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SDF group | Experimental | Participants of SDF group will be applied with SDF before placement of root caries restoration |
|
| Control group | Placebo Comparator | Participants of control group will be applied with placebo (tonic water) before placement of root caries restoration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SDF solution application | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Hong Kong | Recruiting | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27208876 | Background | Li R, Lo EC, Liu BY, Wong MC, Chu CH. Randomized clinical trial on arresting dental root caries through silver diammine fluoride applications in community-dwelling elders. J Dent. 2016 Aug;51:15-20. doi: 10.1016/j.jdent.2016.05.005. Epub 2016 May 18. | |
| 23392087 | Background | Zhang W, McGrath C, Lo EC, Li JY. Silver diamine fluoride and education to prevent and arrest root caries among community-dwelling elders. Caries Res. 2013;47(4):284-90. doi: 10.1159/000346620. Epub 2013 Feb 5. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 6, 2022 | Jul 16, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 12, 2022 | Jul 21, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D017213 | Root Caries |
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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two-arm randomized controlled clinical trial
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Participants, operators and investigators will not be informed of the group allocation
|
| Tonic water | Other | Tonic water will be used as a placebo to mimic the SDF solution. |
|
| 24 months follow-up |
| 16998134 | Background | Lo EC, Luo Y, Tan HP, Dyson JE, Corbet EF. ART and conventional root restorations in elders after 12 months. J Dent Res. 2006 Oct;85(10):929-32. doi: 10.1177/154405910608501011. |