Older Adult Effectiveness of 2 Treatments

NCT03916926 | Completed Results FDA Device

• 1 other identifier: AD-2018-C1-10590
• Study Type: interventional
• Target: 568
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a cluster randomized clinical trial (RCT) to be conducted in 40 (22 originally planned +16 additional) publicly subsidized housing facilities/sites (HUD Section 202) and other low-income housing voucher programs in NE Ohio. The facilities will be randomized to 2 arms: Arm 1 (20 sites) - Participants will receive biannual silver diamine fluoride (SDF) versus Arm 2 (20 sites): Participants will receive atraumatic restorative treatment (ART) with glass ionomer cement (GIC) + biannual fluoride varnish (FV) application. A total of 590 (550 originally planned + 40 additional) participants (Arm 1: 295, Arm 2: 295) will be followed for one year (baseline, 26 weeks, 52 weeks). The protocol for each arm will address both coronal and root surface tooth decay lesions: Arm 1: The treatment will be bi-annual topical 38% SDF(Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL) following manufacturer's instructions and published guidelines; Arm 2: The treatment will be ART will be a modification where the cavity will be restored with high viscosity glass-ionomer cement (GIC) (GC Fuji Automix LC Resin Reinforced Glass Ionomer Restorative, Japan)). Patients will also receive biannual topical fluoride varnish treatments (FluoriMax, Elevate) according to manufacturer's instructions.

Conditions

Dental Caries

Keywords

Dental Caries; Oral Health Quality of Life

Outcome Measures

Primary Outcomes (4)

• Caries Arrest Rate

  International Caries Detection and Assessment System was the standard used to identify active caries lesions by examination at baseline by calibrated dental hygienists. ICDAS examination was then used to assess caries arrest on permanent tooth surfaces with moderate to severe lesions (ICDAS codes 3-6 with activity code 2 (active)) that received SDF or ART + FV treatment baseline. A lesion was considered arrested if, at follow-up, the activity code is 1 (inactive) or the surface is sound (code S). The mean was calculated with standard deviation for both arms.

  Baseline to 26 weeks

• Caries Arrest Rate

  International Caries Detection and Assessment System was the standard used to identify active caries lesions by examination at baseline by calibrated dental hygienists. ICDAS examination was then used to assess caries arrest on permanent tooth surfaces with moderate to severe lesions (ICDAS codes 3-6 with activity code 2 (active)) that received SDF or ART + FV treatment baseline. A lesion was considered arrested if, at follow-up, the activity code is 1 (inactive) or the surface is sound (code S). The mean was calculated with standard deviation for both arms.

  Baseline to 52 weeks

• Tooth Pain

  Tooth Pain and Sensitivity were assessed using the PROMIS v.1.0 - Pain Intensity 3a (Modified for Dental). A mean pain intensity score was created for the 3-item scale and ranged from 0-4 (Had no pain - 0, Mild-1, Moderate-2, Severe-3 to Very Severe - 4) and was then collapsed to 0-2 (No pain-0, mild/moderate-1, and severe/very severe-2. Higher scores indicate more pain.

  Baseline to 26 weeks

• Tooth Pain

  Tooth Pain and Sensitivity were assessed using the PROMIS v.1.0 - Pain Intensity 3a (Modified for Dental). A mean pain intensity score was created for the 3-item scale and ranged from 0-4 (Had no pain - 0, Mild-1, Moderate-2, Severe-3 to Very Severe - 4) and was then collapsed to 0-2 (No pain-0, mild/moderate-1, and severe/very severe-2. Higher scores indicate more pain.

  Baseline to 52 weeks

Secondary Outcomes (4)

• Prevention of New Decay

  Baseline and 26 weeks

• Prevention of New Decay

  Baseline to 52 weeks

• Oral Health Related Quality of Life

  Baseline to 26 weeks

• Oral Health Related Quality of Life

  Baseline to 52 weeks

Study Arms (2)

A "simple medical strategy" consisting of SDF

EXPERIMENTAL

The treatment will be bi-annual application (at baseline and 26 weeks) 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 (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), 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: B "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

Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL)

Also known as: SDF treatment

A "simple medical strategy" consisting of SDF

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

GC Fuji (for ART) and FluoriMax Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL (for FV)

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:

• Provide signed and dated informed consent form
• Willing to comply with all study procedures and be available for the duration of the study (1 year)
• Male or female, aged 62 years or older
• Live in a participating older adult housing facility to continue in the clinical trial phase of the study, an individual must:
• Have at least one untreated active root or coronal carious lesion with ICDAS-II (2015) lesion severity code of 3 or greater

You may not qualify if:

• Sensitivity to silver or other heavy-metal ions
• Those with ulcerative gingivitis or stomatitis
• Serious life-threatening medical disease

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

Location

Related Publications (1)

• Nelson S, Albert JM, Milgrom P. Comparative Effectiveness of Two Nonsurgical Treatments to Reduce Oral Health Disparities From Untreated Tooth Decay in Older Adults: Protocol for a Cluster Randomized Trial. JMIR Res Protoc. 2020 Sep 8;9(9):e17840. doi: 10.2196/17840.

  PMID: 32897236 DERIVED

MeSH Terms

Conditions

Dental Caries

Interventions

Reproductive Techniques, Assisted

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques; Therapeutics; Investigative Techniques

Results Point of Contact

• Title: Suchitra Nelson
• Organization: Case Western Reserve University

suchitra.nelson@case.edu

216-368-3469

Study Officials

• Suchitra S Nelson, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: We will attempt blinding of participants to the study group (participants). The hygienists (care providers) will be unaware of the treatment assignment when they go to their respective housing facilities. For all treatment visits, assessments will be conducted prior to the intervention delivery. Two hygienists will go to the housing facility randomized to the SDF arm and the other two will go to the ART + FV arm. The baseline treatment to be applied will be revealed only after the baseline caries exam has been completed. At the 6 month follow-up visit, the two hygienists that applied SDF will now go to the facilities randomized to the ART + FV facilities and vice-versa to conduct the 6-month follow up caries assessment exam and treatment. We will follow similarly for the 12-moth follow-up visit. By this strategy, we will make sure that potential bias of the hygienist evaluating their own work is minimized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Interim Chair, Department of Community Dentistry

Model Details: The comparative effectiveness of "simple medical", i.e. SDF versus "typical dental", i.e. atraumatic restorative treatment (ART) + fluoride varnish (FV) intervention in this study is focused on the person level to address the unique oral health needs of low-income older adults. The interventions proposed for this study are in current clinical use. Both coronal and root surface tooth decay lesions will be treated. The two evidence-based strategies in older adults will be compared as follows: Arm 1 (N=295 participants): A "simple medical strategy" consisting of SDF versus Arm 2 (N=295 participants): A "typical dental strategy" consisting of ART + FV

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 16, 2019
• Study Start: September 18, 2019
• Primary Completion: June 7, 2024
• Study Completion: June 7, 2024
• Last Updated: August 13, 2025
• Results First Posted: August 13, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)