Silver Diamine Fluoride Application on Root Caries Fillings

The University of Hong Kong (HKU)

Status: Enrolling

Conditions: Root Caries

Treatments: Other: Tonic water; Other: SDF solution application

Study type: Interventional

Funder types: Other

Identifiers

NCT06514885

UW23-005

Details and patient eligibility

About

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

Full 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.

Enrollment: 184 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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184 participants in 2 patient groups, including a placebo group

SDF group

Experimental group

Description:

Participants of SDF group will be applied with SDF before placement of root caries restoration

Treatment:

Other: SDF solution application

Control group

Placebo Comparator group

Description:

Participants of control group will be applied with placebo (tonic water) before placement of root caries restoration

Treatment:

Other: Tonic water