Skip to main content
Clinical Trials/NCT05612451
NCT05612451Active, not recruitingNot Applicable

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

King Abdullah University Hospital1 site in 1 country45 target enrollmentStarted: March 20, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
45
Locations
1
Primary Endpoint
treatment success

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
7 Years to 19 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

non-setting calcium hydroxide

Experimental

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

Intervention: Regenerative Endodontic Procedures (Procedure)

non-setting calcium hydroxide

Experimental

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

Intervention: non-setting calcium hydroxide (Other)

modified triple antibiotic paste

Experimental

Regenerative Endodontic Procedure utilizing modified triple antibiotic paste as intracanal medicament

Intervention: Regenerative Endodontic Procedures (Procedure)

modified triple antibiotic paste

Experimental

Regenerative Endodontic Procedure utilizing modified triple antibiotic paste as intracanal medicament

Intervention: modified triple antibiotic paste (Other)

Outcomes

Primary Outcomes

treatment success

Time Frame: 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 Outcomes

  • root completion(36 months)
  • root maturation(36 months)
  • root elongation(36 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials