Effect of Apical Patency on Periapical Lesion Healing

NCT07867314 | Active Not Recruiting

• 1 other identifier: RTEU-ENDO-GO-01
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

This non-randomized clinical study aims to evaluate the effect of apical patency during root canal treatment on the healing of periapical lesions in maxillary anterior teeth. Participants will be assigned to either an apical patency group or a non-patency group. Changes in periapical lesion volume will be assessed using cone-beam computed tomography (CBCT) one year after treatment. The study aims to provide an objective volumetric assessment of the potential contribution of apical patency to periapical healing.

Conditions

Periapical Lesion; Apical Periodontitis; Dental Pulp Necroses; Mouth Diseases; Periapical Diseases

Keywords

Apical Patency; Root Canal Treatment; Periapical Lesion; Cone-Beam Computed Tomography

Outcome Measures

Primary Outcomes (1)

• Change in periapical lesion volume

  Periapical lesion volume was measured in cubic millimeters (mm³) on clinically indicated pre-treatment CBCT scans using manual three-dimensional segmentation with ITK-SNAP software. One baseline lesion-volume value was obtained for each participant with an evaluable CBCT scan

  Before root canal treatment and at 1 year after treatment

Study Arms (2)

Apical Patency Group

EXPERIMENTAL

Participants received standardized single-visit root canal treatment. During canal preparation, a #10 stainless-steel K-file was passively advanced approximately 0.5-1 mm beyond the working length after each rotary instrument to maintain apical patency. No intentional apical enlargement or dentin removal was performed.

Procedure: Apical Patency During Root Canal Treatment

Non-Patency Group

ACTIVE COMPARATOR

Participants received the same standardized single-visit root canal treatment, but canal preparation was confined to the working length and no instrument was intentionally extended beyond the apical foramen.

Procedure: Root Canal Treatment Without Apical Patency

Interventions

Apical Patency During Root Canal Treatment PROCEDURE

A #10 stainless-steel K-file was passively advanced approximately 0.5-1 mm beyond the working length after each rotary instrument during standardized single-visit root canal treatment.

Apical Patency Group

Root Canal Treatment Without Apical Patency PROCEDURE

Standardized single-visit root canal treatment was performed with instrumentation confined to the working length and without intentional passage of an instrument beyond the apical foramen.

Non-Patency Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients.
• Systemically healthy and not using regular systemic medications.
• A single-rooted maxillary anterior tooth requiring primary root canal treatment.
• Diagnosis of chronic apical periodontitis in the study tooth.
• The tooth was restorable.
• Absence of root fracture or crack.
• Absence of internal or external resorption.
• Root canal negotiable to the apical region with a small hand file.
• Ability to establish a reliable working length.
• Availability of a CBCT scan of the relevant maxillary anterior region, previously obtained for clinical purposes or indicated during the treatment process.

You may not qualify if:

• Pregnancy or breastfeeding.
• Previous endodontic treatment of the study tooth.
• Severe canal calcification.
• Suspected root fracture or crack.
• Internal or external root resorption.
• Periodontal probing depth of 5 mm or greater.
• Previous surgical intervention in the relevant region.
• Inability to negotiate the root canal.
• Inability to establish a reliable working length.

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead

Study Sites (1)

Recep Tayyip Erdogan University Faculty of Dentistry, Department of Endodontics

Rize, Rize Province, 53020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Periodontitis; Dental Pulp Necrosis; Mouth Diseases; Periapical Diseases

Condition Hierarchy (Ancestors)

Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Periodontitis; Dental Pulp Diseases; Tooth Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• gamze özbay

  Recep Tayyip Erdogan University Faculty of Dentistry, Department of Endodontics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start: May 22, 2025
• Primary Completion (Estimated): November 27, 2026
• Study Completion (Estimated): November 27, 2026
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)