Recruiting

Silver Diamine Fluoride vs. Atraumatic Restorative Treatment

Sponsor:

Case Western Reserve University

Code:

NCT07213661

Conditions

Dental Caries

Eligibility Criteria

Sex: All

Age: 62+

Healthy Volunteers: Accepted

Interventions

A "simple medical strategy" consisting of silver diamine fluoride (SDF)

A "typical dental strategy" consisting of atraumatic restorative treatment (ART) with glass ionomer cement + Fluoride Varnish (FV)

Study Details

Brief summary:

This study is a continuation of a cluster randomized clinical trial (cRCT) conducted in 33 publicly subsidized housing facilities/sites (HUD Section 202) and other low-income housing voucher programs in NE Ohio. The Intervention Arm (18 sites) - participants received biannual silver diamine fluoride (SDF) versus the Control Arm (15 sites) where participants received atraumatic restorative treatment (ART) with glass ionomer cement (GIC) + biannual fluoride varnish (FV) application. A total of 568 participants were recruited in the original study, and 480 participants (Intervention Arm: 287, Control Arm: 193) are expected to continue in this long-term follow-up study. Since enrollment in the original study was done over time, each participant will contribute data at 3 to 6 years (from randomization) in the LTFU depending on study entry to assess clinical equipoise of the two treatments.

Community-dwelling older adults, regardless of medical, cognitive, or motor impairments, were considered for inclusion in the original study and were: (1) aged ≥ 62 years in the 33 housing facilities; (2) have at least one untreated active root or coronal carious lesion with ICDAS-II lesion severity code of 3 or greater ; (3) willingness to stay in the study for 1 year. Exclusion criteria: (1) sensitivity to silver or other heavy-metal ions; (2) serious life-threatening medical disease. Additionally, any participant with the presence of gingival/perioral ulceration or stomatitis or tooth abscess in any specific tooth were referred to a dentist and enrolled after resolution. The LTFU study will follow the same enrolled participants long-term. The current mean (sd) age of the 480 participants who will enter the LTFU study will be 73.73 (6.92) years.

Conditions

Dental Caries

Study ID

NCT07213661

Start date

Oct 8, 2025

Status verified date

Nov, 2025

Completion date

Jan, 2030

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 62+

Healthy Volunteers: Accepted

Inclusion Criteria: To be eligible to participate in this study, an individual must meet all of the following criteria:

  • Were participants in the original study from the 33 housing sites
  • Provide signed and dated long-term follow-up informed consent form
  • Willingness to stay in the LTFU study for 1 year
  • Additionally for focus groups, completed the treatment phase of the study

Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study:

  • Sensitivity to silver or other heavy-metal ions
  • Serious life-threatening medical disease
  • Additionally, any participant with the presence of gingival/perioral ulceration or stomatitis or tooth abscess in any specific tooth will be referred to a dentist but can only be enrolled after resolution

Study Design

Enrollment

480 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: A "simple medical strategy" consisting of SDF

This treatment will be a bi-annual application of 38% silver diamine (Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL) solution to new ICDAS lesions code 3-6 (at baseline and 26-weeks or 26-weeks and 52 weeks) following manufacturers instructions and guidelines published by UCSF (2016).

active comparator: A "typical dental strategy" consisting of ART + FV

Atraumatic Restorative Treatment (ART) will be a modification of the approach used by Lo and colleagues (2006),2 and the cavity restored at baseline with resin reinforced glass-ionomer cement (GIC) (GC Corporation, Japan).

Participants in this arm will also receive biannual topical fluoride varnish application (FluoriMax, Elevate) according to manufacturer's instructions.

Interventions

A "simple medical strategy" consisting of silver diamine fluoride (SDF)

Bi-annual topical application of 38% silver diamine solution to new ICDAS lesions code 3-6. Advantage Arrest, Elevate Oral Care, West Palm Beach FL

A "typical dental strategy" consisting of atraumatic restorative treatment (ART) with glass ionomer cement + Fluoride Varnish (FV)

GC Fuji (for ART) and FluoriMax Varnish. Atraumatic Restoration Treatment (ART) to new ICDAS lesions code 3-6, followed by bi-annual topical fluoride varnish (FV) to all teeth.

Primary outcome measure

  • Caries Arrest Rate [ Time Frame: Baseline (LTFU 1) to 52-weeks (LTFU 3) ]
  • New Decay Rate [ Time Frame: Baseline (LTFU 1) to 52-weeks (LTFU 3) ]
  • Tooth Loss [ Time Frame: Baseline (LTFU 1) to 52-weeks (LTFU 3) ]
  • Tooth Pain [ Time Frame: Baseline (LTFU 1) to 52-weeks (LTFU 3) ]
  • Oral Health Related Quality of Life [ Time Frame: Baseline (LTFU 1) to 52-weeks (LTFU 3) ]

Central Contacts and Locations

Central contacts

Suchitra S Nelson, PhD

216-368-3469sxn15@case.edu

Shelley Curtan, MEd

216-368-3968sgc36@case.edu

Locations

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Suchitra S Nelson, PhD

216-368-3469sxn15@case.edu

Principal Investigator:

Suchitra S Nelson, PhD

More Information

Sponsor

Case Western Reserve University

Last update posted

Nov 13, 2025

Last verified

Nov, 2025

Keywords

  • Dental Caries
  • Oral Health Quality of Life
  • Tooth Loss

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Western Reserve University on 2025-11-13.