- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05213026
Comparison of Apexification and Regenerative Endodontic Therapy: a Retrospective Study
Effects of Apexification and Regenerative Endodontic Therapy on the Periapical Bone in Immature Teeth: a Retrospective Study
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey
- Istanbul University, Faculty of dentistry
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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,
|
|
|
Regenerative
Apexification treatment was applied by a single operator (GK) in Istanbul University Faculty of Dentistry, Department of Pedodontics,
|
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
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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