LT Comparative Effectiveness of 2 Caries Treatments

NCT07213661 | Recruiting FDA Device

• 2 other identifiers: STUDY20250955LTF-2024C2-39677
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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

Keywords

Dental Caries; Oral Health Quality of Life; Tooth Loss

Outcome Measures

Primary Outcomes (5)

• Caries Arrest Rate

  ICDAS examinations are used to assess caries arrest on permanent tooth surfaces with moderate to severe lesions (ICDAS codes 3-6 with activity code 2) that received SDF or ART + FV treatment. A lesion is considered arrested if, at follow-up, the activity code is 1 (inactive) or the surface is sound (code S). The overall mean will be calculated by surfaces.

  Baseline (LTFU 1) to 52-weeks (LTFU 3)

• New Decay Rate

  New decay is defined as ICDAS lesion code ≥3 (localized to extensive decay) on one or more surfaces on newly decayed teeth found at LFTU #1, #2 and #3 (even on surfaces that did not receive the study treatments). The overall mean of decayed surfaces will be calculated.

  Baseline (LTFU 1) to 52-weeks (LTFU 3)

• Tooth Loss

  Tooth loss will be assessed through ICDAS exams by documenting absence of teeth. The overall mean will be calculated for the number of teeth lost.

  Baseline (LTFU 1) to 52-weeks (LTFU 3)

• Tooth Pain

  Tooth Pain and Sensitivity will be assessed using the PROMIS v.1.0 - Pain Intensity 3a \[Modified for Dental\]. An overall mean pain intensity score will be created for the 3-item Likert scale with answers ranging from 0-no pain to 4-very severe.

  Baseline (LTFU 1) to 52-weeks (LTFU 3)

• Oral Health Related Quality of Life

  Geriatric Oral Health Related Quality of Life (GOHRQoL) is an overall score created by taking the sum of each of the 12 items, which are on a Likert scale using 3 levels (Always/Often - 1, Sometimes/Seldom - 2, Never - 3). The scores range from 12-36 with higher scores indicating better quality of life. The overall mean for the participant population will be calculated.

  Baseline (LTFU 1) to 52-weeks (LTFU 3)

Secondary Outcomes (1)

• Gingival Inflammation Index

  Baseline (LTFU 1) to 52-weeks (LTFU 3)

Study Arms (2)

A "simple medical strategy" consisting of SDF

EXPERIMENTAL

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).

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

A "typical dental strategy" consisting of ART + FV

ACTIVE COMPARATOR

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.

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

Interventions

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

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

Also known as: SDF Treatment

A "simple medical strategy" consisting of SDF

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

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.

Also known as: ART + FV Treatment

A "typical dental strategy" consisting of ART + FV

Eligibility Criteria

• Age: 62 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Western Reserve University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Dental Caries; Tooth Loss

Interventions

Reproductive Techniques, Assisted

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Suchitra S Nelson, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suchitra S Nelson, PhD

CONTACT

216-368-3469; sxn15@case.edu

Shelley Curtan, MEd

CONTACT

216-368-3968; sgc36@case.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: We will maintain blinding of participants to the study arm but this may not be possible due to SDF color change. Clinical and study staff cannot be blinded due to the nature of the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean of Clinical and Translational Research Professor and Interim Chair, Community Dentistry

Model Details: The interventions will be continued in this long-term follow-up study for any new decay. Both coronal and root surface tooth decay lesions will be treated. The two evidence-based strategies in older adults will be compared as follows: Intervention Arm 1: A "simple medical strategy" consisting of SDF Participants will receive bi-annual application of topical 38% silver diamine fluoride (Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL) following manufacturer's instructions and guidelines published by UCSF. Control Arm 2: 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.

Study Record Dates

• First Submitted: October 3, 2025
• First Posted: October 9, 2025
• Study Start: October 8, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)