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Triple Antibiotic Paste for Tooth Pulp Necrosis

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

Study Summary

This trial is testing whether a new tissue engineering procedure can improve outcomes for teeth with pulpal necrosis, compared to standard apexification treatment.

Eligible Conditions
  • Tooth Pulp Necrosis
  • Regeneration

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tooth Survival
Secondary outcome measures
Positive pulpal response

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
687 Previous Clinical Trials
374,521 Total Patients Enrolled
Loma Linda UniversityOTHER
306 Previous Clinical Trials
260,863 Total Patients Enrolled

Frequently Asked Questions

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

How many clinical sites are administering this experimental protocol?

"This clinical trial is welcoming patients at Loma Linda University in California, the University of North carolina in Chapel Hill and the University of Texas Health Science Centre based in San Antonio as well as 4 other medical centres."

Answered by AI

Has Triple Antibiotic Paste been tested in any prior research trials?

"The first trial of Triple Antibiotic Paste was conducted by the University of Nebraska Medical Center in 2007. Presently, 498 studies have concluded with 88 still running; many within Loma Linda, California."

Answered by AI

Is the age ceiling for this research project inclusive of individuals aged 75 or above?

"This trial is accepting participants aged 6 and above but not exceeding 20 years old."

Answered by AI

What common medical conditions is Triple Antibiotic Paste administered for?

"Triple Antibiotic Paste is an effective solution for treating otitis externa, candidal vulvovaginitis, and relapsing fever."

Answered by AI

Who are the eligible individuals for this clinical trial?

"This research project is seeking 125 kids aged between 6 and 20 who have pulp mummification. Vital criterion requiring patient's participation include the ability to provide informed assent/consent, being within the specified age range, as well as possessing a tooth that can be restored with Class A or B (as per Samet & Jotkowitz classification) without needing stainless steel crowns."

Answered by AI

How many participants are joining this experiment?

"Unfortunately, this clinical trial is no longer seeking patients at the moment. It was initially posted on September 1st 2014 and updated recently on August 8th 2022. For individuals considering other trials, there are currently 75 studies searching for participants with pulp mummification and 88 research projects actively enrolling volunteers who need Triple Antibiotic Paste treatment."

Answered by AI

Is Triple Antibiotic Paste a reliable treatment option for patients?

"The safety of Triple Antibiotic Paste was assigned a score of 1, as this Phase 1 trial only has preliminary data indicating its efficacy and limited information on safety."

Answered by AI

Are there still opportunities for individuals to join this experiment?

"Unfortunately, the research detailed on clinicaltrials.gov is no longer seeking participants, having first been posted in September of 2014 and last updated August 8th 2022. However, 163 alternative trials are currently accepting patient enrolment at this time."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
University of Texas Health Science Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I could benefit from this treatment. I am a single mother and low income and can afford to fix my dental issues , so I think this is something that can help me while.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Regeneration of Pulp-Dentin Development in Teeth With Necrotic Pulps and Immature Roots
Kenneth Hargreaves 2014. "Regeneration of Pulp-Dentin Development in Teeth With Necrotic Pulps and Immature Roots". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01976065.
~12 spots leftby Apr 2025
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