CompletedEarly Phase 1

Tissue Characterization in Teeth Treated With a Regeneration Protocol

United States1 participantsStarted 2010-03

Plain-language summary

The purpose of the investigators study is to characterize the composition of the hard and soft tissues present in root canals of teeth previously diagnosed with necrotic pulps and incomplete root formation and treated with a triple antibiotic regeneration protocol. The investigators hypothesis is that treatment of teeth with necrotic pulps and immature apices with triple antibiotic paste will stimulate continued root formation by the deposition of dentin at the root apices. The primary outcome measure will be histological identification of mineralized tissue and adherent cells in the apical third of these teeth.

Who can participate

Age range

10 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient Inclusion Criteria: * Healthy volunteers ages 10-60 with a non-restorable (as determined by referring dentist), permanent tooth with a necrotic pulp and incomplete root development. * Persons who seem to be cooperative with dental treatment and able to indicate willingness to obtain treatment and participate in the study and who are capable of verbally expressing dissent. * Parents who express understanding of study treatments and consent to treatment for their child of the regenerative procedure. * Healthy patients (ASA Class I or II physical status) with no systemic health problems that may interfere with healing and cell growth. * Tooth inclusion criteria: * Permanent tooth with necrotic pulp and immature root development, scheduled for extraction due to non-restorability. * Clinically confirmed necrotic pulp that will be confirmed with common endodontic pulp vitality tests (No response to cold or electric pulp test). * Clinically confirmed immature root development that will be assessed radiographically to confirm the non-restorability as diagnosed by the referring dentist. Exclusion Criteria: * Patient Exclusion Criteria: * Parents and patients unable to give consent or express dissent. * Patients who are unwilling to undergo the dental treatment. * Patients affected by temporomandibular joint disorders. * Patients affected by known orofacial pain disorders. * Patients with ASA Class III or IV physical status (I…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The primary outcome measure will be histological identification of mineralized tissue and adherent cells in the apical third of these teeth.

Timeframe: three year

Trial details

NCT IDNCT00881907

SponsorThe University of Texas Health Science Center at San Antonio

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-03

View on ClinicalTrials.gov More Pulp Necrosis trials