Long-Term Study of Caries Treatments in Older Adults
This study is looking at how well two different treatments work to stop tooth decay (dental caries) in older adults. It's a follow-up to an earlier study. One treatment is a "simple medical strategy" using silver diamine fluoride (SDF), which is applied to new decay. The other is a "typical dental strategy" involving atraumatic restorative treatment (ART) with glass ionomer cement (a type of filling) and fluoride varnish. Researchers want to see if SDF works as well as ART plus fluoride varnish to stop new decay, prevent tooth loss, and arrest existing decay over one year. You may be able to join if you were part of the original study in one of the 33 housing sites in Northeast Ohio, are willing to participate for one year, and provide consent.
- Study design
- This is a continuation of a cluster randomized clinical trial, meaning groups of participants (from housing sites) were randomly assigned to receive one of two treatments. About 480 participants are expected to continue in this long-term follow-up study.
- What's involved
- You would be followed for one year, receiving intervention when new decay is present. You would also participate in clinical and questionnaire evaluations.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for one year after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
LT Comparative Effectiveness of 2 Caries Treatments
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Suchitra S Nelson, PhD · PRINCIPAL_INVESTIGATOR · Case Western Reserve University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Caries Arrest RateBaseline (LTFU 1) to 52-weeks (LTFU 3)
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.
- New Decay RateBaseline (LTFU 1) to 52-weeks (LTFU 3)
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.
- Tooth LossBaseline (LTFU 1) to 52-weeks (LTFU 3)
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.
- Tooth PainBaseline (LTFU 1) to 52-weeks (LTFU 3)
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.
- Oral Health Related Quality of LifeBaseline (LTFU 1) to 52-weeks (LTFU 3)
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.