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Completed

NCT Number: NCT05213026

Comparison of Apexification and Regenerative Endodontic Therapy: 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).

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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University, Faculty of Dentistry

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regenerative endodontics

Procedure

Regenerative endodontic procedure with 3 Mix-MP

Primary outcomes

  1. Healing

    Time frame: 1 year

    PAI score ≤ 3

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Collaborators

  • Abant Izzet Baysal University
  • Istanbul Kent University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jan 28, 2022
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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