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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05213026
Other study ID # 2019/53
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 7, 2020
Est. completion date January 4, 2022

Study information

Verified date March 2024
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 4, 2022
Est. primary completion date March 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Regenerative endodontics
Regenerative endodontic procedure with 3 Mix-MP

Locations

Country Name City State
Turkey Istanbul University, Faculty of Dentistry Istanbul

Sponsors (3)

Lead Sponsor Collaborator
Istanbul University Abant Izzet Baysal University, Istanbul Kent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Healing PAI score = 3 1 year
See also
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Completed NCT03849222 - Evaluation the Effect of Using of Apical Matrix With Apexification Procedure on Apical Healing of Necrotic Immature Teeth Phase 2/Phase 3