Silver Diamine Fluoride Application on Root Caries Fillings

Not Applicable

Recruiting

• Conditions: Root Caries
• Interventions: Other: Tonic water; Other: SDF solution application

• Registration Number: NCT06514885
• Lead Sponsor: The University of Hong Kong

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.

Study Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-22
• Study First Posted: 2024-07-23
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-09
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 184

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Tonic water	Participants of control group will be applied with placebo (tonic water) before placement of root caries restoration
SDF group	SDF solution application	Participants of SDF group will be applied with SDF before placement of root caries restoration

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong