Clinical trial NCT06514885: Silver Diamine Fluoride Application on Root Caries Fillings
Official title: Influence of Silver Diamine Fluoride Application on the Restorative Treatment for Root Caries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Root Caries
Keywords: silver diamine fluoride
older adults
restorative treatment
root caries
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 184
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two-arm randomized controlled clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical outcome
timeFrame: 24 months follow-up
Secondary outcomes:
measure: Patient-based subjective evaluation
timeFrame: 24 months follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.