Single Versus Multiple Visits Regenerative Endodontics in Mature Teeth

March 13, 2026 updated by: Marmara University

Postoperative Pain and Healing Outcomes After Single Versus Multiple Visits Regenerative Endodontic Treatment in Mature Teeth With Chronic Apical Periodontitis: A Randomized Clinical Trial

The goal of this clinical trial is to learn whether regenerative endodontic treatment (RET) should be performed in one visit or two visits in people with mature permanent teeth with chronic apical periodontitis.

RET is a dental treatment used for teeth with necrotic pulp and infection around the root. The procedure disinfects the root canal and promotes the formation of new tissue inside the canal space, which may support healing of the tissues around the tooth root.

The main questions this study aims to answer are:

Does single-visit RET cause different levels of postoperative pain compared with two-visit RET? Do teeth treated with single-visit or two-visit RET show different levels of healing around the root? Participants will receive RET using either a single-visit or two-visit treatment protocol. Participants will record their pain levels during the first week after treatment using a visual analog scale (VAS). Participants will return for follow-up visits at six months and one year, when dental radiographs will be taken to evaluate healing around the tooth root.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

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)
        • Marmara University Faculty of Dentistry

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 The inclusion criteria for this study were defined as follows: individuals aged between 18 and 40 years who were classified as ASA I (systemically healthy) according to the American Society of Anesthesiologists (ASA) classification; mature permanent teeth with completed root development (closed apex); single-rooted and single-canal maxillary central or lateral incisors; teeth that had not received previous endodontic treatment; teeth diagnosed with chronic apical periodontitis and presenting with a lesion with a periapical index (PAI) score ≥3 according to the classification; teeth that were asymptomatic in the preoperative clinical evaluation; teeth that were restorable and did not require post or core placement for permanent restoration; and patients who signed the informed consent form to participate in the study.

Exclusion Criteria The exclusion criteria were as follows: individuals younger than 18 years or older than 40 years; patients with systemic diseases classified as ASA II or higher according to the ASA classification; pregnant or breastfeeding women; teeth with root fractures or internal or external root resorption; and teeth presenting with advanced periodontal destruction, pathological periodontal pocket depth ≥3 mm, or mobility greater than Grade 1.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-Visit RET
Procedure: Single-Visit Regenerative Endodontic Treatment
Regenerative endodontic treatment was performed in a single clinical visit in mature permanent teeth diagnosed with chronic apical periodontitis. During the procedure, the root canal system was cleaned through chemomechanical preparation using mechanical instrumentation and irrigation solutions. Apical bleeding was then induced to create a biological scaffold within the canal space. A mineral trioxide aggregate (MTA) coronal barrier was placed over the blood clot. After the setting of MTA, the access cavity was restored with a definitive coronal restoration the following day.
Experimental: Multiple-Visit RET
Procedure: Multiple-Visit Regenerative Endodontic Treatment
Regenerative endodontic treatment was performed in multiple clinical visits in mature permanent teeth diagnosed with chronic apical periodontitis. During the first visit, the root canal system was cleaned through chemomechanical preparation using mechanical instrumentation and irrigation solutions, and an intracanal medicament was placed. At the second visit, the intracanal medicament was removed and apical bleeding was induced to create a biological scaffold within the canal space. MTA coronal barrier was placed over the blood clot. After the setting of MTA, the access cavity was restored with a definitive coronal restoration the following day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primer success
Time Frame: 12 months
Primary success is defined as the absence of clinical symptoms and evidence of periapical healing on radiographs.
12 months
Secondary success
Time Frame: 12 months
Positive response to electric pulp testing is assessed.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain
Time Frame: 8 hours, 24 hours, 48 hours, and 7 days after each treatment visit
Postoperative pain is assessed using a visual analog scale (VAS), and overall pain is calculated using the area under the curve (AUC) of VAS scores.
8 hours, 24 hours, 48 hours, and 7 days after each treatment visit
Periapical Lesion Area
Time Frame: Baseline and 12 months
Changes in periapical lesion area are assessed using digital radiographic analysis.
Baseline and 12 months
Mean Gray Value
Time Frame: Baseline and 12 months
Changes in bone density in the periapical region are assessed using mean gray value measurements obtained from digital radiographs.
Baseline and 12 months
Fractal Dimension
Time Frame: Baseline and 12 months
Changes in trabecular bone microarchitecture in the periapical region are assessed using fractal dimension analysis.
Baseline and 12 months

Collaborators and Investigators

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

Sponsor

Marmara University

Collaborators

Marmara University Scientific Research Projects Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 1, 2024

Primary Completion (Actual)

January 30, 2026

Study Completion (Actual)

January 30, 2026

Study Registration Dates

First Submitted

March 13, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2024/13/878

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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