Outcome of Regenerative Endodontic Procedures

Study Overview
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Brief Summary
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Clinical management of immature non-vital (necrotic) permanent teeth is challenging, due to inherent structural weakness. Earlier management of such teeth relied on the traditional calcium hydroxide (Ca(OH)2) apexification procedure or the application of apical barriers However, neither procedure allows for promoting root dentin maturation. In 2004, a novel management technique for treating immature, non-vital teeth called regenerative endodontic procedures (REP; also known as revascularization) was introduced. This procedure allowed for continued root maturation presented in an increase in root length and dentin wall thickness. The key points of REP include minimal or no instrumentation of the dentinal walls, disinfection with irrigant solutions and intracanal medicaments, provocation of bleeding into the canal space for creation of a blood clot, capping with calcium silicate-based material, and an effective coronal seal to prevent reinfection of the root canal system. Several case reports and clinical studies reported promising results for REP treatment. However, studies widely varied in their treatment methods, hence the search for an optimal REP protocol is still ongoing. A recent review reported that the methodological quality of REP clinical trials available to date, was low with a moderate to high risk of bias. To date, only few studies evaluated the outcome of REPs based on different types of intracanal medicaments. These studies either presented a retrospective design, low sample size and/or short follow up period. Hence, the need for randomized, controlled clinical studies to provide persuasive evidence on the efficacy of different intracanal medicaments in REP is of utmost importance. The aim of this study is to prospectively assess and compare the clinical and radiographic outcomes of REP in non-vital immature permanent teeth using an intracanal medicament modified TAP or non-setting Ca(OH)2 paste. Forty-five patients yielding a total of 50 anterior and posterior non-vital immature teeth were randomly divided into 2 groups. REP utilizing either non-setting calcium hydroxide (Ca(OH)2) (n=25) or modified triple antibiotic paste (TAP) (n=25), as intracanal medicaments were performed. NeoMTA Plus was applied for coronal sealing. Cases were followed up clinically and radiographically for 24 months. Survival rate, success rate, and clinical outcome measures were analyzed.

Official Title
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Outcome of Regenerative Endodontic Procedures for Necrotic Immature Permanent Teeth, Using Two Different Protocols: A Prospective Randomized Clinical Study.

Conditions
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Endodontic Disease

Intervention / Treatment
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* Procedure: Regenerative Endodontic Procedures
* Other: non-setting calcium hydroxide
* Other: modified triple antibiotic paste


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Anterior or posterior tooth diagnosed with necrotic pulp (as a result of trauma, caries or anomaly) in the presence or absence of apical periodontitis. an immature apex or open apex(an apical diameter wider than 1 mm and is radiographically visible) Pulp space not needed for post and core restoration A cooperative and Compliant patient/ parent Patients not allergic to medicaments necessary to complete the procedure. Exclusion Criteria: medically compromised patient, teeth with vertical fractures, periodontally involved teeth, non-restorable teeth, teeth when bleeding could not be induced.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 19 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This randomized clinical trial aimed to assess and compare the clinical and radiographic outcomes of Regenerative Endodontic Procedures (REP) in treating non-vital immature permanent teeth using two intracanal medicaments.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: non-setting calcium hydroxide<br>Regenerative Endodontic Procedure utilizing non-setting calcium hydroxide as intracanal medicament | Procedure: Regenerative Endodontic Procedures<br>* Regenerative Endodontic procedures were performed by one operator following similar protocols according to the clinical considerations for a regenerative procedure advised by the American Association of Endodontists and European Society of Endodontology<br>Other: non-setting calcium hydroxide<br>* non-setting calcium hydroxide<br>|
| Experimental: modified triple antibiotic paste<br>Regenerative Endodontic Procedure utilizing modified triple antibiotic paste as intracanal medicament | Procedure: Regenerative Endodontic Procedures<br>* Regenerative Endodontic procedures were performed by one operator following similar protocols according to the clinical considerations for a regenerative procedure advised by the American Association of Endodontists and European Society of Endodontology<br>Other: modified triple antibiotic paste<br>* modified triple antibiotic paste<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment success | disappearance of clinical signs and symptoms including tenderness to percussion or palpation, a swelling or sinus tract, or spontaneous pain, and absence or reduction in the size of periapiacl radiolucency | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| root elongation | increased root length | 36 months | 
| root maturation | increased root dentin thickness | 36 months | 
| root completion | apical closure | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endodontic regeneration, Immature teeth, Randomized controlled trial