Comparison of Apexification and Regenerative Endodontic Therapy: a Retrospective Study

March 4, 2024 updated by: Yelda Kasımoğlu, Istanbul University

Effects of Apexification and Regenerative Endodontic Therapy on the Periapical Bone in Immature Teeth: a Retrospective Study

In this study, the effects of mineral trioxide aggregation (MTA) apexification and regenerative endodontic treatment (RET) methods on periapical healing was compared with fractal analysis (FD) and periapical index (PAI).

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The fractal dimension analysis of each radiograph was performed using the box-counting method proposed by White and Rudolph [1] (Figure 1). All periapical radiographs in high resolution Jpeg format to be included in the study was converted to tagged image file formats (TIFF). Each ROI at 18 x 19 pixels and 2 mm from the radiographic apex was selected, cropped and amplified. "Gaussian Blur" was used to eliminate the brightness changes due to soft tissues and variable bone thicknesses. The resulting image was then be subtracted from the original image. Bone marrow spaces and trabeculae were separated from each other by adding 128 gray values to each pixel location. The fractal dimension was calculated after the binary, etching, dilate, inversion and skeletonization operations were done.

This study was carried out on the radiographic records of patients who applied to Istanbul University Faculty of Dentistry, Department of Pedodontics, who had at least one immature incisor treated with MTA apexification and RET method, and who had at least one-year follow-up radiographs.

Cases in which all endodontic treatments were performed by the same pedodontist (GK) were examined.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey
        • Istanbul University, Faculty of dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The database of patients who underwent apexification treatment by a single operator (GK) at Istanbul University Faculty of Dentistry, Department of Pedodontics was examined.

Description

Inclusion Criteria:

  • Apexification treatment was applied by a single operator (GK) in Istanbul University Faculty of Dentistry, Department of Pedodontics,

    • Having no systemic or periodontal problems,
    • Asymptomatic or diagnosed with apical periodontitis with fistula tract,
    • Not having external/internal resorption, fracture, more than one root/canal,
    • Root canal filling is sufficient for the MTA group,
    • Root canal filling and coronal restorations were completed in Istanbul University Faculty of Dentistry Department of Pedodontics,
    • Cases with periapical radiographs taken before the procedure and at least one year after the procedure was included.

Exclusion Criteria:

  • Cases treated by different pediatric dentists,

    • Cases in which apexification is performed by different operators,
    • Cases with systemic or periodontal disease,
    • Cases with external/internal resorption, fracture, more than one root/canal,
    • Cases where root canal filling is not sufficient
    • Cases in which root canal filling and conoral restorations were completed over 2 years,
    • Cases without radiographs taken before or at least one year after the procedure,
    • Cases with artifacts in the periapical region on their radiographs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Apexification

Apexification treatment was applied by a single operator (GK) in Istanbul University Faculty of Dentistry, Department of Pedodontics,

  • Having no systemic or periodontal problems,
  • Asymptomatic or diagnosed with apical periodontitis with fistula tract,
  • Not having external/internal resorption, fracture, more than one root/canal,
  • Root canal filling is sufficient for the MTA,
  • Root canal filling and coronal restorations were completed in Istanbul University Faculty of Dentistry Department of Pedodontics,
  • Cases with periapical radiographs taken before the procedure and at least one year after the procedure was included.
Regenerative

Apexification treatment was applied by a single operator (GK) in Istanbul University Faculty of Dentistry, Department of Pedodontics,

  • Having no systemic or periodontal problems,
  • Asymptomatic or diagnosed with apical periodontitis with fistula tract,
  • Not having external/internal resorption, fracture, more than one root/canal,
  • Root canal filling and coronal restorations were completed in Istanbul University Faculty of Dentistry Department of Pedodontics,
  • Cases with periapical radiographs taken before the procedure and at least one year after the procedure was included.
Regenerative endodontic procedure with 3 Mix-MP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing
Time Frame: 1 year
PAI score ≤ 3
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2020

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

January 4, 2022

Study Registration Dates

First Submitted

January 18, 2022

First Submitted That Met QC Criteria

January 18, 2022

First Posted (Actual)

January 28, 2022

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2019/53

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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