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NCT Number: NCT06514885

Silver Diamine Fluoride Application on Root Caries Fillings

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

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Key information

Conditions

Root Caries Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

  • 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;
  • Compare patient-based subjective evaluations on the two different approaches mentioned-above in treating root caries lesions.

Hypotheses to be tested:

  • Prior SDF application increases the success rate of restorations placed in root caries;
  • Patient-based subjective evaluations of the treatment outcomes are better when SDF is applied to the root caries lesions prior to restoring the lesions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Tonic water

Other

Tonic water will be used as a placebo to mimic the SDF solution.

Primary outcomes

  1. Clinical outcome

    Time frame: 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 outcomes

  1. Patient-based subjective evaluation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Influence of Silver Diamine Fluoride Application on the Restorative Treatment for Root Caries

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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