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Outcome of Regenerative Endodontic Procedures

Primary Purpose

Endodontic Disease

Status
Active
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Regenerative Endodontic Procedures
non-setting calcium hydroxide
modified triple antibiotic paste
Sponsored by
King Abdullah University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontic Disease focused on measuring Endodontic regeneration, Immature teeth, Randomized controlled trial

Eligibility Criteria

7 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jordan University of Science & Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

non-setting calcium hydroxide

modified triple antibiotic paste

Arm Description

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

Regenerative Endodontic Procedure utilizing modified triple antibiotic paste as intracanal medicament

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

root elongation
increased root length
root maturation
increased root dentin thickness
root completion
apical closure

Full Information

First Posted
November 2, 2022
Last Updated
November 9, 2022
Sponsor
King Abdullah University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05612451
Brief Title
Outcome of Regenerative Endodontic Procedures
Official Title
Outcome of Regenerative Endodontic Procedures for Necrotic Immature Permanent Teeth, Using Two Different Protocols: A Prospective Randomized Clinical Study.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 20, 2018 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Abdullah University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontic Disease
Keywords
Endodontic regeneration, Immature teeth, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
non-setting calcium hydroxide
Arm Type
Experimental
Arm Description
Regenerative Endodontic Procedure utilizing non-setting calcium hydroxide as intracanal medicament
Arm Title
modified triple antibiotic paste
Arm Type
Experimental
Arm Description
Regenerative Endodontic Procedure utilizing modified triple antibiotic paste as intracanal medicament
Intervention Type
Procedure
Intervention Name(s)
Regenerative Endodontic Procedures
Intervention Description
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
Other
Intervention Name(s)
non-setting calcium hydroxide
Intervention Description
non-setting calcium hydroxide
Intervention Type
Other
Intervention Name(s)
modified triple antibiotic paste
Intervention Description
modified triple antibiotic paste
Primary Outcome Measure Information:
Title
treatment success
Description
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
Time Frame
36 months
Secondary Outcome Measure Information:
Title
root elongation
Description
increased root length
Time Frame
36 months
Title
root maturation
Description
increased root dentin thickness
Time Frame
36 months
Title
root completion
Description
apical closure
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aladdin A Al-Qudah, PhD
Organizational Affiliation
Jordan University of Science & Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jordan University of Science & Technology
City
Irbid
ZIP/Postal Code
22110
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication will be shared
IPD Sharing Time Frame
starting 12 months after publication
IPD Sharing Access Criteria
will be sent by email, upon request
Citations:
PubMed Identifier
28508244
Citation
Duggal M, Tong HJ, Al-Ansary M, Twati W, Day PF, Nazzal H. Interventions for the endodontic management of non-vital traumatised immature permanent anterior teeth in children and adolescents: a systematic review of the evidence and guidelines of the European Academy of Paediatric Dentistry. Eur Arch Paediatr Dent. 2017 Jun;18(3):139-151. doi: 10.1007/s40368-017-0289-5. Epub 2017 May 15. Erratum In: Eur Arch Paediatr Dent. 2017 Jun;18(3):153.
Results Reference
result
PubMed Identifier
25443280
Citation
Saoud TM, Zaazou A, Nabil A, Moussa S, Lin LM, Gibbs JL. Clinical and radiographic outcomes of traumatized immature permanent necrotic teeth after revascularization/revitalization therapy. J Endod. 2014 Dec;40(12):1946-52. doi: 10.1016/j.joen.2014.08.023. Epub 2014 Oct 16.
Results Reference
result
PubMed Identifier
33934366
Citation
European Society of Endodontology (ESE) developed by:; Krastl G, Weiger R, Filippi A, Van Waes H, Ebeleseder K, Ree M, Connert T, Widbiller M, Tjaderhane L, Dummer PMH, Galler K. European Society of Endodontology position statement: endodontic management of traumatized permanent teeth. Int Endod J. 2021 Sep;54(9):1473-1481. doi: 10.1111/iej.13543. Epub 2021 Jun 20.
Results Reference
result
PubMed Identifier
34352304
Citation
Sponchiado-Junior EC, Vieira WA, Frozoni M, Herkrath FJ, de-Jesus-Soares A. CONSORT Compliance in Randomized Clinical Trials of Regenerative Endodontic Treatments of Necrotic Immature Teeth: A Scoping Review. J Endod. 2021 Nov;47(11):1751-1766. doi: 10.1016/j.joen.2021.07.017. Epub 2021 Aug 3.
Results Reference
result
PubMed Identifier
28110920
Citation
Chan EK, Desmeules M, Cielecki M, Dabbagh B, Ferraz Dos Santos B. Longitudinal Cohort Study of Regenerative Endodontic Treatment for Immature Necrotic Permanent Teeth. J Endod. 2017 Mar;43(3):395-400. doi: 10.1016/j.joen.2016.10.035. Epub 2017 Jan 19.
Results Reference
result
PubMed Identifier
32249441
Citation
ElSheshtawy AS, Nazzal H, El Shahawy OI, El Baz AA, Ismail SM, Kang J, Ezzat KM. The effect of platelet-rich plasma as a scaffold in regeneration/revitalization endodontics of immature permanent teeth assessed using 2-dimensional radiographs and cone beam computed tomography: a randomized controlled trial. Int Endod J. 2020 Jul;53(7):905-921. doi: 10.1111/iej.13303. Epub 2020 Apr 30.
Results Reference
result

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Outcome of Regenerative Endodontic Procedures

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