Apical Preparation Size in Regenerative Endodontics of Mature Teeth

March 7, 2026 updated by: Marmara University

The Effect of Apical Preperation Size on the Success of Regenerative Endodontic Treatment in Mature Teeth With Apical Periodontitis: A Randomized Clinical Trial

The goal of this clinical trial is to learn whether the size of apical preparation affects the success of regenerative endodontic treatment in mature permanent teeth with apical periodontitis. Regenerative endodontic treatment is a procedure that aims to eliminate infection and support healing of the tissues around the root of the tooth.

The main questions the study aims to answer are:

  • Does a larger apical preparation improve healing around the root tip?
  • Does apical preparation size affect pain after treatment or recovery of tooth vitality?

Researchers compared two treatment approaches that use different apical preparation sizes to see if one leads to better clinical and radiographic healing.

Participants:

  • Received regenerative endodontic treatment with one of two apical preparation sizes
  • Attended follow-up visits for clinical examination and radiographic evaluation
  • Were monitored for pain and healing outcomes during the follow-up period

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34854
        • Marmara University Faculty of Dentistry, Department of Endodontics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Single-rooted mature teeth with periapical lesions
  • Teeth with a PAI score ≥ 3
  • Patients aged 18-45 years
  • Systemically healthy individuals
  • Patients who provided written informed consent

Exclusion Criteria:

  • Immature teeth
  • Previously root canal treated teeth
  • Teeth with a PAI score <3
  • Developmental anomalies
  • Advanced periodontal destruction
  • Internal/external resorption
  • History of trauma
  • Patients with systemic diseases
  • Pregnant or breastfeeding patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MAF 40 group
Participants receive regenerative endodontic treatment with apical preparation completed to ISO size 40.
Procedure: Regenerative Endodontic Treatment
Regenerative endodontic treatment (RET) is a biologically based procedure that includes root canal disinfection followed by placement of a biological scaffold to support tissue regeneration and periapical healing. In this study, the intervention differs according to the apical preparation size used (ISO 40 and ISO 80) in mature teeth with apical periodontitis.
Experimental: MAF 80 group
Participants receive regenerative endodontic treatment with apical preparation completed to ISO size 80.
Procedure: Regenerative Endodontic Treatment
Regenerative endodontic treatment (RET) is a biologically based procedure that includes root canal disinfection followed by placement of a biological scaffold to support tissue regeneration and periapical healing. In this study, the intervention differs according to the apical preparation size used (ISO 40 and ISO 80) in mature teeth with apical periodontitis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primer success
Time Frame: 6 months and 12 months
Primer success is evaluated based on the absence of clinical symptoms and radiographic healing of the periapical lesion.
6 months and 12 months
Secondary success
Time Frame: 6 months and 12 months
Secondary success was defined as the recovery of pulp sensibility, evaluated using cold and electric pulp tests during follow-up examinations.
6 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain
Time Frame: baseline, day 1, day 2, and day 7 after treatment
Postoperative pain was evaluated using a visual analogue scale.
baseline, day 1, day 2, and day 7 after treatment
Periapical Lesion Area
Time Frame: Baseline, 6 months, 12 months
Changes in the periapical lesion area were measured using digital radiographic analysis.
Baseline, 6 months, 12 months
Mean Gray Value
Time Frame: Baseline, 6 months, 12 months
Bone density changes in the periapical region were evaluated using mean gray value measurements obtained from digital radiographs.
Baseline, 6 months, 12 months
Fractal Dimension
Time Frame: Baseline, 6 months, 12 months
Changes in trabecular bone microarchitecture in the periapical region were evaluated using fractal dimension analysis.
Baseline, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2024

Primary Completion (Actual)

October 23, 2025

Study Completion (Actual)

October 23, 2025

Study Registration Dates

First Submitted

March 7, 2026

First Submitted That Met QC Criteria

March 7, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 7, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/13/877

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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