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All participants for Tooth Decay

N/A
Waitlist Available
Led By Jayakumar Jayaraman, BDS, MDS, FDSRCS, MS, PhD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12, 18, 24 and 36 months
Awards & highlights

Study Summary

This trial aims to compare resin polymer crowns and stainless steel crowns to see which one is better for fixing children's teeth. The goal is to find the crown that works best in restoring the teeth

Who is the study for?
This trial is for individuals with primary molar tooth decay who need crowns to restore tooth function and prevent further decay or infection. Specific eligibility criteria are not provided, but typically participants would have no allergies to dental materials and be in good general health.Check my eligibility
What is being tested?
The study is comparing the effectiveness of two types of crowns for restoring primary molars: one made from a resin polymer (NuSmile BioFlx) and another from stainless steel (3M ESPE). The goal is to see which material better restores function and prevents future caries.See study design
What are the potential side effects?
Potential side effects may include discomfort during fitting, sensitivity in the treated tooth, allergic reactions if there's an allergy to materials used, or issues with crown fit leading to additional dental procedures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 12, 18, 24 and 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 12, 18, 24 and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The success of Bioflx crown in primary molars in comparisons with stainless steel molars through clinical assessments
The success of Bioflx crown in primary molars in comparisons with stainless steel molars through radiographic assessments
Secondary outcome measures
Child satisfaction
Parental satisfaction

Trial Design

1Treatment groups
Experimental Treatment
Group I: All participantsExperimental Treatment2 Interventions
Each participant will receive a BioFLX crown and a stainless steel crown.

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
699 Previous Clinical Trials
22,884,965 Total Patients Enrolled
Jayakumar Jayaraman, BDS, MDS, FDSRCS, MS, PhDPrincipal InvestigatorVirginia Commonwealth University
1 Previous Clinical Trials
75 Total Patients Enrolled

Frequently Asked Questions

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

Can individuals who have surpassed the age of 80 partake in this research study?

"This research is open to individuals above 36 months and below 84 months of age."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Resin Polymer (NuSmile BioFlx) Compared to Stainless Steel Crowns (3M ESPE) for Restoration of Primary Molar Teeth
2024. "Resin Polymer (NuSmile BioFlx) Compared to Stainless Steel Crowns (3M ESPE) for Restoration of Primary Molar Teeth". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06354634.
~53 spots leftby Jul 2027
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