480 Participants Needed

Dental Treatments for Tooth Decay

SS
SC
Overseen ByShelley Curtan, MEd
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Case Western Reserve University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two dental treatments to determine which is more effective for tooth decay. One group receives silver diamine fluoride (SDF) applied twice a year, while the other group undergoes atraumatic restorative treatment (ART) with glass ionomer cement plus fluoride varnish. The trial targets older adults who previously participated in the study and have untreated cavities. Participants must remain involved for at least another year. The study aims to determine which treatment maintains healthier teeth over the long term. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance dental care for others.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, but it's best to confirm with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that silver diamine fluoride (SDF) effectively stops tooth decay. However, it can cause permanent black staining on treated areas of teeth, the most common side effect, which does not affect the treatment's overall safety.

Research indicates that atraumatic restorative treatment (ART) with glass ionomer cement (GIC) gently treats tooth decay. Simple hand tools clean the cavity, and a special cement is applied to protect it. The fluoride varnish in this treatment helps prevent further decay and is generally well-tolerated.

Both treatments have been widely used and are considered safe for most people. This trial does not involve a new treatment, so existing data and experience provide the safety information.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for tooth decay because they offer potential new ways to manage cavities with less invasive techniques. Silver Diamine Fluoride (SDF) is unique because it not only arrests decay but also reinforces the tooth structure and prevents further damage, all with a simple application. Unlike traditional fillings, which often require drilling, Atraumatic Restorative Treatment (ART) with Glass Ionomer Cement (GIC) minimizes discomfort by restoring the tooth with a less invasive approach and adding the protective benefits of fluoride varnish. These treatments aim to simplify the dental care process, making it more accessible and less intimidating for patients.

What evidence suggests that this trial's treatments could be effective for tooth decay?

Research has shown that Silver Diamine Fluoride (SDF), one of the treatments in this trial, effectively stops tooth decay. Studies have found that applying SDF twice a year can halt cavities and is particularly beneficial in community settings. However, it may cause permanent black stains on treated areas. Another treatment option in this trial, Atraumatic Restorative Treatment (ART) using Glass Ionomer Cement (GIC) and Fluoride Varnish (FV), effectively manages tooth decay, especially for cavities on a single surface. GIC has been shown to reduce the risk of new cavities by 76% on healthy teeth. Both treatments have strong evidence supporting their effectiveness in treating tooth decay.678910

Who Is on the Research Team?

SS

Suchitra S Nelson, PhD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

This trial is for community-dwelling older adults aged 62 or above with untreated tooth decay, who participated in the original study and consent to a long-term follow-up. They must be willing to stay in the study for another year and have completed prior treatment phases. Those with silver sensitivity, serious diseases, or certain oral health issues are excluded.

Inclusion Criteria

Provided signed and dated long-term follow-up informed consent form
Willingness to stay in the LTFU study for 1 year
Completed the treatment phase of the study for focus groups
See 1 more

Exclusion Criteria

Sensitivity to silver or other heavy-metal ions
I have gum sores, mouth ulcers, or a tooth abscess.
I have a serious, life-threatening medical condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive biannual silver diamine fluoride (SDF) or atraumatic restorative treatment (ART) with glass ionomer cement (GIC) and biannual fluoride varnish (FV) application for new decay

52 weeks
3 visits (in-person) at baseline, 26 weeks, and 52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants contribute data at 3 to 6 years post-randomization to assess clinical equipoise of the two treatments

3-6 years

What Are the Treatments Tested in This Trial?

Interventions

  • Atraumatic Restorative Treatment with Glass Ionomer Cement + Fluoride Varnish
  • Silver Diamine Fluoride
Trial Overview The trial compares two dental caries treatments: biannual application of silver diamine fluoride (SDF) versus atraumatic restorative treatment (ART) with glass ionomer cement plus biannual fluoride varnish (FV). Participants from previous phases continue into this long-term follow-up to assess effectiveness over 3-6 years.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: A "simple medical strategy" consisting of SDFExperimental Treatment1 Intervention
Group II: A "typical dental strategy" consisting of ART + FVActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials
314
Recruited
236,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+

Citations

Assessment of Atraumatic Restorative Treatment (ART) on ...ART was shown to be acceptable and effective in the management of single surface occlusal caries in the permanent dentition in these Nigerian children and ...
LT Comparative Effectiveness of 2 Caries TreatmentsDevice : A "typical dental strategy" consisting of atraumatic restorative treatment (ART) with glass ionomer cement + Fluoride Varnish (FV).
Updates on the clinical application of glass ionomer ...GIC sealants was effective in preventing caries on sound tooth surfaces including occlusal fissure surfaces, decreasing the caries risk of sound teeth by 76% ...
Comparative Effectiveness of Two Nonsurgical Treatments ...The primary outcomes are caries lesion arrest, tooth sensitivity, and tooth pain at 52 weeks after treatment. Analytic methods for the primary ...
Atraumatic restorative treatment versus conventional ...Radiation‐induced root surface caries restored with glass‐ionomer cement placed in conventional and ART cavity preparations: results at two years.
Glass Ionomer Cement - StatPearls - NCBI BookshelfGlass ionomer cement (GIC) is a self-adhesive restorative material.[1] Chemically, it combines fluoro-aluminosilicate glass powder and polyacrylic acid liquid.
The atraumatic restorative treatment (ART) approach for ...The ART approach involves the use of hand instruments only to remove carious tooth substance and then restoring the cavity and sealing any adjacent enamel ...
Atraumatic Restorative Treatment - an overviewAtraumatic restorative treatment (ART) usually consists of manual soft caries excavation followed by high-viscosity GIC restorations under cotton-roll isolation ...
Atraumatic Restorative Treatment: Indications, Technique & ...Atraumatic Restorative Treatment (ART) is a minimally invasive approach for managing dental caries, focusing on preserving tooth structure.
Topical Medicaments for Caries Prevention or ...Topical Application of Fluoride Varnish. Fluoride varnish may be the preferred delivery method for the following: Children under age 6.
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