Regenerative EndodonticNCT05213026
Comparison of Apexification and Regenerative Endodontic Therapy: a Retrospective Study
An observational study of Regenerative Endodontic and Apexification, run by Istanbul University at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Regenerative Endodontic, Apexification, Fractals
- What is being tested?
- Regenerative endodontics
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Oct 2020to 4 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Faculty of Dentistry
Istanbul
About this study
Official title: 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).
Read the 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.
- Conditions
- Regenerative Endodontic, Apexification, Fractals
- Being tested
- Regenerative endodontics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regenerative endodonticsProcedure or surgery
Regenerative endodontic procedure with 3 Mix-MP
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Regenerative endodontics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing
PAI score ≤ 3
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start7 Oct 2020
- Primary completion1 Mar 2021
- Study completion4 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regenerative EndodonticStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Kent University, Abant Izzet Baysal University
- Responsible party
- Principal investigator, Yelda Kasımoğlu, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213026
- Sponsor's protocol ID
- 2019/53
- Status last verified
- Mar 2024
- First submitted
- 18 Jan 2022
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Apexification and Regenerative Endodontic Therapy on the Periapical Bone in Immature Teeth: a Retrospective Study
- ClinicalTrials.gov ID
- NCT05213026
- Acronym / sponsor ID
- 2019/53
- Conditions
- Regenerative Endodontic, Apexification, Fractals
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Istanbul Kent University, Abant Izzet Baysal University
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 4 Jan 2022 (actual)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Procedure: Regenerative endodonticsApexification 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. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (7 listed)
- Apexification treatment was applied by a single operator (GK) in Istanbul University Faculty of Dentistry, Department of Pedodontics,
Key exclusion criteria (8 listed)
- Cases treated by different pediatric dentists,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regenerative endodonticsRegenerative endodontic procedure with 3 Mix-MP | Procedure or surgery | Regenerative |
Primary outcome
Healing
Time frame: 1 year
PAI score ≤ 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Regenerative Endodontic and Apexification, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.