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Triple Antibiotic Paste for Regeneration

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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

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