NCT05213026

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

January 18, 2022

Last Update Submit

March 4, 2024

Conditions

Regenerative EndodonticApexificationFractals

Outcome Measures

Primary Outcomes (1)

  • Healing

    PAI score ≤ 3

    1 year

Study Arms (2)

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.

Procedure: Regenerative endodontics

Interventions

Regenerative endodonticsPROCEDURE

Regenerative endodontic procedure with 3 Mix-MP

Regenerative

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Faculty of Dentistry

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Regenerative Endodontics

Intervention Hierarchy (Ancestors)

EndodonticsDentistry

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

January 18, 2022

First Posted

January 28, 2022

Study Start

October 7, 2020

Primary Completion

March 1, 2021

Study Completion

January 4, 2022

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)