NCT03916926

Older Adult Effectiveness of 2 Treatments

Completed NA Results posted Last updated 13 August 2025

What this trial tests

NA trial testing A "simple medical strategy" consisting of silver diamine fluoride (SDF) in Dental Caries in 568 participants. Completed in 7 June 2024.

Timeline

18 September 2019

Primary endpoint
7 June 2024

7 June 2024

Quick facts

Lead sponsor	Case Western Reserve University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	568
Start date	18 September 2019
Primary completion	7 June 2024
Estimated completion	7 June 2024
Sites	1 location across United States

Drugs / interventions tested

• A "simple medical strategy" consisting of silver diamine fluoride (SDF)
• B "typical dental strategy" consisting of atraumatic restorative treatment (ART) with glass ionomer cement + Fluoride varnish (FV)

Conditions studied

• Dental Caries — all drugs for Dental Caries →

Sponsor

Case Western Reserve University

Who can join

62 and older, any sex, with Dental Caries. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Caries Arrest Rate Primary · Baseline to 26 weeks

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.

Group	Value	95% CI
A "Simple Medical Strategy" Consisting of SDF	0.75	± 0.36
A "Typical Dental Strategy" Consisting of ART + FV	0.91	± 0.21

Caries Arrest Rate Primary · Baseline to 52 weeks

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.

Group	Value	95% CI
A "Simple Medical Strategy" Consisting of SDF	0.88	± 0.25
A "Typical Dental Strategy" Consisting of ART + FV	0.92	± 0.21

Tooth Pain Primary · Baseline to 26 weeks

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.

Group	Value	95% CI
A "Simple Medical Strategy" Consisting of SDF	0.27	± 0.50
A "Typical Dental Strategy" Consisting of ART + FV	0.21	± 0.44

Tooth Pain Primary · Baseline to 52 weeks

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.

Group	Value	95% CI
A "Simple Medical Strategy" Consisting of SDF	0.21	± 0.43
A "Typical Dental Strategy" Consisting of ART + FV	0.25	± 0.49

Prevention of New Decay Secondary · Baseline and 26 weeks

New decay was defined as ICDAS lesion code ≥3 (localized to extensive decay) on one or more surfaces on teeth previously not found at baseline even on surfaces that did not receive the study treatments. ICDAS examination was used to determine the count of newly decayed surfaces on teeth and the mean was calculated.

Group	Value	95% CI
A "Simple Medical Strategy" Consisting of SDF	0.94	± 2.03
A "Typical Dental Strategy" Consisting of ART + FV	0.52	± 1.46

Prevention of New Decay Secondary · Baseline to 52 weeks

New decay was defined as ICDAS lesion code ≥3 (localized to extensive decay) on one or more surfaces on teeth previously not found at baseline even on surfaces that did not receive the study treatments. ICDAS examination was used to determine the count of newly decayed surfaces on teeth and the mean was calculated.

Group	Value	95% CI
A "Simple Medical Strategy" Consisting of SDF	0.67	± 1.72
A "Typical Dental Strategy" Consisting of ART + FV	0.66	± 1.71

Oral Health Related Quality of Life Secondary · Baseline to 26 weeks

Geriatric Oral Health Related Quality of Life (GOHRQoL) overall score is created by taking the sum of each of the 12 items, which were collected using a Likert type scale with 3 levels (Always/Often - 1, Sometimes/Seldom - 2, Never - 3). The overall scores ranged from 12-36 with higher scores indicating better quality of life. The mean was calculated for the SDF and ART groups.

Group	Value	95% CI
A "Simple Medical Strategy" Consisting of SDF	30.73	± 4.33
A "Typical Dental Strategy" Consisting of ART + FV	30.45	± 4.43

Oral Health Related Quality of Life Secondary · Baseline to 52 weeks

Geriatric Oral Health Related Quality of Life (GOHRQoL) overall score is created by taking the sum of each of the 12 items, which were collected using a Likert type scale with 3 levels (Always/Often - 1, Sometimes/Seldom - 2, Never - 3). The overall scores ranged from 12-36 with higher scores indicating better quality of life. The mean was calculated for the SDF and ART groups.

Group	Value	95% CI
A "Simple Medical Strategy" Consisting of SDF	30.44	± 4.65
A "Typical Dental Strategy" Consisting of ART + FV	30.04	± 4.94

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected from baseline to the 52 week follow-up.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

A "Simple Medical Strategy" Consisting of SDF

Serious: 14/346 (4%)

Deaths: 14/346

A "Typical Dental Strategy" Consisting of ART + FV

Serious: 8/222 (4%)

Deaths: 8/222

Serious adverse events (1 terms)

Reaction	System	A "Simple Medical Strategy…	A "Typical Dental Strategy…
Death	General disorders	—	—

Most-reported serious reactions: Death.

Data from ClinicalTrials.gov NCT03916926 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Comparative Effectiveness of Two Nonsurgical Treatments to Reduce Oral Health Disparities From Untreated Tooth Decay in Older Adults: Protocol for a Cluster Randomized Trial.
   Nelson S, Albert JM, Milgrom P. · · 2020 · cited 3× · PMID 32897236 · DOI 10.2196/17840
2. Community-dwelling older adults’ satisfaction and experiences with two non-surgical caries treatments: a mixed methods study
   Bales G, Curtan S, Hickey K, Cohen A, et al ·
3. A Cluster-Randomized Clinical Trial of Silver Diamine Fluoride vs Atraumatic Restoration in Older Adults.
   Nelson S, Albert JM, Selvaraj D, Milgrom P, et al · · 2026 · PMID 41846540 · DOI 10.1177/00220345261429949