CompletedPhase 1

Regeneration of Pulp-Dentin Development in Teeth With Necrotic Pulps and Immature Roots

United States125 participantsStarted 2014-09

Plain-language summary

This multi-center exploratory clinical trial is a randomized trial designed to test whether a regenerative endodontic procedure using tissue engineering principles (REGENDO), or a revascularization (REVASC) endodontic procedure, in comparison to standard apexification treatment using a mineral trioxide aggregate barrier (apexification; APEX), produces a significantly better composite clinical outcome for the treatment of immature permanent teeth with pulpal necrosis.

Who can participate

Age range

6 Years – 20 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: * Age 6-20 * Participant has a permanent tooth with a necrotic pulp (as defined by lack of responsiveness to both electrical pulp tests and cold \[EndoIce\] tests). If the tooth was traumatized, then pulpal necrosis is defined as either: 1) no response to both electrical pulp test and cold \[EndoIce\] test by three months after trauma, or 2) presence of a periapical lesion, or 3) radiographic evidence of root resorption, or 4) discoloration of the crown. * Tooth in question is restorable (as defined by Class A or Class B using Samet and Jotkowitz classification) without the need of a stainless steel crown. * Incomplete (i.e., immature) root development defined by apical foramen ≥1.0mm (each foramina \>1.0mm for multi-rooted teeth). * At least 5 mm of root development (CEJ to radiographic apex). * Willing and able to provide informed assent/consent. * Legal guardian willing and able to provide informed consent. Exclusion Criteria: * No access to telephone for study contacts. * Unable to comprehend study materials in English or Spanish. * Subject not available for follow up at 12 or 24 months. * Previous allergic response to ciprofloxacin, metronidazole or minocycline or any materials used in the study. * History of systemic diseases with altered immune function including diabetes, immunodeficiency, leukemia, Addison's or Cushing's disease. * History of taking immunosuppressants or chemotherapeutic agents including glucocorticoids in the past 3 months. * …

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

Tooth Survival

Timeframe: 2 years

Trial details

NCT IDNCT01976065

SponsorKenneth Hargreaves

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09-24

View on ClinicalTrials.gov More Pulp Necrosis trials