Outcome of Regenerative Endodontic Procedures

Not Applicable

Active, not recruiting

• Conditions: Endodontic Disease
• Interventions: Procedure: Regenerative Endodontic Procedures; Other: non-setting calcium hydroxide; Other: modified triple antibiotic paste

• Registration Number: NCT05612451
• Lead Sponsor: King Abdullah University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-20
• Primary Completion: 2021-06-30
• Status Verified: 2022-11
• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-09
• Last Update Submitted: 2022-11-09
• Study First Posted: 2022-11-10
• Last Update Posted: 2022-11-10
• Study Completion: 2024-06-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 45

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-setting calcium hydroxide	non-setting calcium hydroxide	Regenerative Endodontic Procedure utilizing non-setting calcium hydroxide as intracanal medicament
non-setting calcium hydroxide	Regenerative Endodontic Procedures	Regenerative Endodontic Procedure utilizing non-setting calcium hydroxide as intracanal medicament
modified triple antibiotic paste	Regenerative Endodontic Procedures	Regenerative Endodontic Procedure utilizing modified triple antibiotic paste as intracanal medicament
modified triple antibiotic paste	modified triple antibiotic paste	Regenerative Endodontic Procedure utilizing modified triple antibiotic paste as intracanal medicament

Primary Outcome Measures

Name	Time	Method
treatment success	36 months	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

Secondary Outcome Measures

Name	Time	Method
root maturation	36 months	increased root dentin thickness
root elongation	36 months	increased root length
root completion	36 months	apical closure

Trial Locations

Locations (1)

Jordan University of Science & Technology; 🇯🇴 Irbid, Jordan