NCT05612451

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 10, 2022

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2024

Completed
Last Updated

November 10, 2022

Status Verified

November 1, 2022

Enrollment Period

3.3 years

First QC Date

November 2, 2022

Last Update Submit

November 9, 2022

Conditions

Endodontic Disease

Keywords

Endodontic regenerationImmature teethRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • root elongation

    36 months

  • root maturation

    36 months

  • root completion

    36 months

Study Arms (2)

non-setting calcium hydroxide

EXPERIMENTAL

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

Procedure: Regenerative Endodontic ProceduresOther: non-setting calcium hydroxide

modified triple antibiotic paste

EXPERIMENTAL

Regenerative Endodontic Procedure utilizing modified triple antibiotic paste as intracanal medicament

Procedure: Regenerative Endodontic ProceduresOther: modified triple antibiotic paste

Interventions

Regenerative Endodontic ProceduresPROCEDURE

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 pastenon-setting calcium hydroxide
non-setting calcium hydroxideOTHER

non-setting calcium hydroxide

non-setting calcium hydroxide
modified triple antibiotic pasteOTHER

modified triple antibiotic paste

modified triple antibiotic paste

Eligibility Criteria

Age7 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • medically compromised patient,
  • teeth with vertical fractures,
  • periodontally involved teeth,
  • non-restorable teeth,
  • teeth when bleeding could not be induced.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan University of Science & Technology

Irbid, 22110, Jordan

Location

Related Publications (6)

  • 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.

    PMID: 28508244RESULT

  • 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.

    PMID: 25443280RESULT

  • 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.

    PMID: 33934366RESULT

  • 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.

    PMID: 34352304RESULT

  • 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.

    PMID: 28110920RESULT

  • 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.

    PMID: 32249441RESULT

MeSH Terms

Conditions

Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Aladdin A Al-Qudah, PhD

    Jordan University of Science & Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2022

First Posted

November 10, 2022

Study Start

March 20, 2018

Primary Completion

June 30, 2021

Study Completion

June 27, 2024

Last Updated

November 10, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication will be shared

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
starting 12 months after publication
Access Criteria
will be sent by email, upon request

Locations

JO(1)