Silver Diamine Fluoride Application on Root Caries Fillings

NCT06514885 | Recruiting

• 1 other identifier: UW23-005
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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. 1.Compare the success of fillings placed in dental root decay that have prior SDF application and those without prior SDF application;
2. 2.Compare patient-based subjective evaluations on the two approaches mentioned above in treating root caries.
3. 3.prior SDF application before receiving root caries fillings
4. 4.directly receiving root caries fillings without any SDF application

Conditions

Root Caries

Keywords

silver diamine fluoride; older adults; restorative treatment; root caries

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Patient-based subjective evaluation

  24 months follow-up

Study Arms (2)

SDF group

EXPERIMENTAL

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

Other: SDF solution application

Control group

PLACEBO COMPARATOR

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

Other: Tonic water

Interventions

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.

SDF group

Tonic water OTHER

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

Control group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older adults (aged 60 or above)
• At least one untreated decayed dental root

You may not qualify if:

• No self-care ability for basic daily activities
• Teeth with severe decay (cannot be filled)
• Teeth indicated for extraction

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (3)

• 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.

  PMID: 27208876 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.

  PMID: 23392087 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.

  PMID: 16998134 BACKGROUND

MeSH Terms

Conditions

Root Caries

Condition Hierarchy (Ancestors)

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants, operators and investigators will not be informed of the group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two-arm randomized controlled clinical trial

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 23, 2024
• Study Start: October 1, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)