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Restorative Material

SDF vs ART + Fluoride Varnish for Tooth Decay

N/A

Waitlist Available

Led By Suchitra S Nelson, PhD

Research Sponsored by Case Western Reserve University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have at least one untreated active root or coronal carious lesion with ICDAS-II (2015) lesion severity code of 3 or greater

Male or female, aged 62 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change between baseline and 52 weeks

Awards & highlights

Study Summary

This trial is testing whether silver diamine fluoride or atraumatic restorative treatment + fluoride varnish is more effective in preventing tooth decay in low-income housing facilities.

Who is the study for?

This trial is for people aged 62 or older living in certain low-income housing facilities who have at least one untreated tooth decay lesion. They must be able to follow the study's procedures for a year and not have life-threatening diseases, allergies to silver/heavy metals, or severe gum disease.Check my eligibility

What is being tested?

The trial compares two dental treatments on older adults: Arm 1 uses a biannual application of silver diamine fluoride (SDF), while Arm 2 uses atraumatic restorative treatment (ART) with glass ionomer cement plus biannual fluoride varnish. Each group has 275 participants.See study design

What are the potential side effects?

Possible side effects include sensitivity reactions to SDF or materials used in ART, such as glass ionomer cement. There may also be temporary discomfort from the dental treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have at least one untreated cavity that is moderate or worse.

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I am 62 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between baseline and 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change between baseline and 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change between baseline and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

caries arrest

Hypersensitivity

Secondary outcome measures

oral health quality of life: Participant questionnaire

prevention of new decay

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: A "simple medical strategy" consisting of SDFExperimental Treatment1 Intervention

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).

Group II: A "typical dental strategy" consisting of ART + FVActive Control1 Intervention

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.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Patient-Centered Outcomes Research InstituteOTHER

550 Previous Clinical Trials

29,996,358 Total Patients Enrolled

Case Western Reserve UniversityLead Sponsor

299 Previous Clinical Trials

259,507 Total Patients Enrolled

Suchitra S Nelson, PhDPrincipal InvestigatorCase Western Reserve University

Media Library

ART with GIC + FV (Restorative Material) Clinical Trial Eligibility Overview. Trial Name: NCT03916926 — N/A

Tooth Decay Research Study Groups: A "typical dental strategy" consisting of ART + FV, A "simple medical strategy" consisting of SDF

Tooth Decay Clinical Trial 2023: ART with GIC + FV Highlights & Side Effects. Trial Name: NCT03916926 — N/A

ART with GIC + FV (Restorative Material) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03916926 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are participating in this medical study?

"Positive, the clinicaltrials.gov database reports that this research endeavour is currently in search of volunteers. As per its initial posting on September 18th 2019 and subsequent updates to February 8th 2022, 590 individuals are needed from 1 specific location."

Answered by AI

Are there still opportunities to enroll in this venture?

"Data hosted on clinicaltrials.gov indicates that this medical study, initially posted in September of 2019, is actively recruiting participants. The trial was last modified on February 8th 2022."

Answered by AI

Recent research and studies

JMIR Research ProtocolsJournal

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, Suchitra, Jeffrey M Albert, and Peter Milgrom. 2020. “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 Research Protocols. JMIR Publications Inc.. doi:10.2196/17840.

clinicaltrials.govStudy

Older Adult Effectiveness of 2 Treatments

Suchitra Nelson 2019. "Older Adult Effectiveness of 2 Treatments". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03916926.