Endodontic Regenerative Procedure for Immature Non-vital Teeth

Study Overview
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Brief Summary
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In this clinical trial the investigators will evaluate an alternate treatment option, which was developed for teeth with incomplete roots, called Regenerative Endodontic Procedure (REP). This treatment works by harnessing the blood clot formed within the root canal from tissues surrounding the root as a scaffold for stem cells. These cells could help to increase the thickness and length of the root canal walls resulting in root end maturation. Results from the 50 participants who will receive the REP treatment will be compared with findings with historical data.

Detailed Description
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All participants will be prospectively assigned to the REP treatment group. Results from the treatment group will be compared to historical controls of all subjects treated by Ca(OH)2 or MTA apexification in the last 10 years (2007-2017) at the Boston University Henry M Goldman School of Dental Medicine. All materials used in this protocol are FDA approved and commercially available for similar applications. This study does not seek a new use or application of any materials, instead recommendations of the American Association of Endodontists (AAE) will be followed to evaluate outcomes associated with the REP compare to the standard of care Ca(OH)2 or MTA apexification. The overall objective for this research is the elimination of any clinical symptoms and the evidence of bony healing as examined by radiographs. Other objectives include increased root wall thickness and/or increased root length and positive response to vitality testing, which if achieved, could indicate a more organized vital pulp tissue.

Official Title
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Endodontic Regenerative Procedure for Immature Non-vital Teeth

Conditions
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Tooth, Nonvital

Intervention / Treatment
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* Other: Regenerative Endodontic Procedure (REP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects followed prospectively 7-18 years old salvageable permanent non-vital tooth with immature apex whether anterior or posterior receiving dental care at the Henry M. Goldman School of Dentistry Historical controls 7-18 year old salvageable permanent non-vital tooth with immature apex whether anterior or posterior received care and has accessible records at the Henry M. Goldman School of Dentistry had either the Calcium hydroxide apexification or MTA apexification between 2007 and 2017 Exclusion Criteria: allergic to medications necessary to complete procedure health status not in: a) ASA-1 no organic pathology or patients in whom the pathological process is localized and does not cause any systemic disturbance or abnormality; nor b) ASA 2 A moderate but definite systemic disturbance, caused either by the condition that is to be treated or surgical intervention or which is caused by other existing pathological processes history of dental trauma within 6 months due to possibility of internal and external root resorption. if tooth pulp space is needed for post/core final restoration pregnancy in female subjects

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REP Group<br>All participants in this single arm study will receive Regenerative Endodontic Procedure (REP). It regenerates the root tip on recently erupted permanent teeth that did not complete root development due to pulp infection and necrosis by allowing cells to migrate from the surrounding periapical tissue and enter the pulp space. Cells contained within the intentional bleeding create at the root tip help in root completion as well as increasing the thickness of the canal walls over up to two years following the procedure. | Other: Regenerative Endodontic Procedure (REP)<br>* Regenerative Endodontic Procedure (REP) involves disinfection of the root canal with the use of acombination of three antibiotics including ciprofloxacin, metronidazole, minocycline. At the second visit, the patient is evaluated for resolution of signs or symptoms of an acute infection and if none then bleeding is induced, the site covered with a plug and the patient is evaluated at follow up.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| periradicular bone healing | Bone healing will be determined by calculating the difference in the bone thickness in millimeters comparing baseline to 24 months on radiographs | 24 months | 
| periradicular bone infection | Assess and document any signs/symptoms of infection at the second visit | 1-4 weeks after first visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tooth root thickness at 12 months | The tooth root thickness will be measured in millimeters, comparing the pre-procedure radiographs and Cone-Beam-Computed Tomography scans (CBCT) to radiographs and CBCT at 12 months | 12 months | 
| tooth root thickness at 24 months | The tooth root thickness will be measured in millimeters, comparing the pre-procedure radiographs and Cone-Beam-Computed Tomography scans (CBCT) to radiographs and CBCT at 24 months | 24 months | 
| tooth root length at 12 months | The tooth root length will be measured in millimeters, comparing the pre-procedure radiographs and Cone-Beam-Computed Tomography scans (CBCT) to radiographs and CBCT at 12 months | 12 months | 
| tooth root length at 24 months | The tooth root length will be measured in millimeters, comparing the pre-procedure radiographs and Cone-Beam-Computed Tomography scans (CBCT) to radiographs and CBCT at 24 months | 24 months | 
| tooth vitality at 12 months | A pain response to hot/cold and electrical pulp tester will be done to test the vitality of the tooth pulp at 12 months | 12 months | 
| tooth vitality at 24 months | A pain response to hot/cold and electrical pulp tester will be done to test the vitality of the tooth pulp at 24 months | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Regenerative endodontic procedure (REP), Mineral Trioxide Aggregate (MTA) apexification, Calcium Hydroxide -Ca(OH)2, Permanent non-vital tooth, Children 7-18 years of age