Outcome of Regenerative Endodontic Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-20

Study Completion Date

2024-06-27

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.

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Detailed Description

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Conditions

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Endodontic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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non-setting calcium hydroxide

Regenerative Endodontic Procedure utilizing non-setting calcium hydroxide as intracanal medicament

Group Type EXPERIMENTAL

Regenerative Endodontic Procedures

Intervention Type PROCEDURE

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

non-setting calcium hydroxide

Intervention Type OTHER

non-setting calcium hydroxide

modified triple antibiotic paste

Regenerative Endodontic Procedure utilizing modified triple antibiotic paste as intracanal medicament

Group Type EXPERIMENTAL

Regenerative Endodontic Procedures

Intervention Type PROCEDURE

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

modified triple antibiotic paste

Intervention Type OTHER

modified triple antibiotic paste

Interventions

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Regenerative Endodontic Procedures

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

Intervention Type PROCEDURE

non-setting calcium hydroxide

Intervention Type OTHER

modified triple antibiotic paste

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Anterior or posterior tooth diagnosed with necrotic pulp (as a result of trauma, caries or anomaly) in the presence or absence of apical periodontitis.
2. an immature apex or open apex(an apical diameter wider than 1 mm and is radiographically visible)
3. Pulp space not needed for post and core restoration
4. A cooperative and Compliant patient/ parent
5. Patients not allergic to medicaments necessary to complete the procedure.

Exclusion Criteria

1. medically compromised patient,
2. teeth with vertical fractures,
3. periodontally involved teeth,
4. non-restorable teeth,
5. teeth when bleeding could not be induced.

Minimum Eligible Age

7 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No