Apical Preparation Size in Regenerative Endodontics of Mature Teeth

NCT07466433 | Completed

• 1 other identifier: 2024/13/877
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Apical Periodontitis; Mature Teeth; Regenerative Endodontic Treatment

Outcome Measures

Primary Outcomes (2)

• Primer success

  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

  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 Outcomes (4)

• Postoperative Pain

  baseline, day 1, day 2, and day 7 after treatment

• Periapical Lesion Area

  Baseline, 6 months, 12 months

• Mean Gray Value

  Baseline, 6 months, 12 months

• Fractal Dimension

  Baseline, 6 months, 12 months

Study Arms (2)

MAF 40 group

EXPERIMENTAL

Participants receive regenerative endodontic treatment with apical preparation completed to ISO size 40.

Procedure: Regenerative Endodontic Treatment

MAF 80 group

EXPERIMENTAL

Participants receive regenerative endodontic treatment with apical preparation completed to ISO size 80.

Procedure: Regenerative Endodontic Treatment

Interventions

Regenerative Endodontic Treatment PROCEDURE

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.

MAF 40 group; MAF 80 group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Faculty of Dentistry, Department of Endodontics

Istanbul, Istanbul, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2026
• First Posted: March 12, 2026
• Study Start: July 29, 2024
• Primary Completion: October 23, 2025
• Study Completion: October 23, 2025
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)