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Regeneration of Pulp-Dentin Development in Teeth With Necrotic Pulps and Immature Roots
Phase 1
Waitlist Available
Research Sponsored by Kenneth Hargreaves
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing three different treatments for healing immature permanent teeth with dead tissue inside. The treatments include growing new tissue, restoring blood flow, and sealing the tooth to prevent further damage. The goal is to find out which method helps the tooth become stronger and last longer.
Eligible Conditions
- Tooth Decay
- Regeneration
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Tooth Survival
Secondary study objectives
Positive pulpal response
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Revascularization Treatment (REVASC)Experimental Treatment1 Intervention
Consists of standard treatment procedure PLUS disinfection of the canal space with Triple Antibiotic Paste study medication followed by placement of Collaplug, an FDA approved material to help promote clotting. A composite restoration in then placed.
Group II: Regeneration Treatment (REGENDO)Experimental Treatment1 Intervention
Consists of standard treatment procedure PLUS Triple Antibiotic Paste study medication PLUS use of Emdogain, an FDA approved medication used in an FDA approved manner, that is a growth factor to help surrounding tissues to grow together and heal.
Group III: Mineral Trioxide Aggregate (MTA)Experimental Treatment1 Intervention
Standard Treatment group consisting of placement of Mineral Trioxide Aggregate (MTA), an FDA approved dental material at the end of an immature root followed by a composite restoration (crown).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Triple Antibiotic Paste
2010
Completed Phase 1
~140
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Kenneth HargreavesLead Sponsor
2 Previous Clinical Trials
University of Maryland, BaltimoreOTHER
716 Previous Clinical Trials
380,989 Total Patients Enrolled
Loma Linda UniversityOTHER
316 Previous Clinical Trials
266,550 Total Patients Enrolled
University of North CarolinaOTHER
170 Previous Clinical Trials
1,455,339 Total Patients Enrolled
American Association of EndodontistsOTHER
2 Previous Clinical Trials
99 Total Patients Enrolled
Kenneth Hargreaves, DDS, PhDStudy ChairUniversity of Texas