Apical Patency, Periapical Lesion Volume, and Postoperative Pain After Root Canal Treatment

NCT07782515 | Completed

• 1 other identifier: RTEU-ENDO-2025-330
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective clinical study evaluated whether maintaining apical patency during single-visit root canal treatment influences postoperative pain in adults with single-rooted maxillary anterior teeth and chronic apical periodontitis. Participants were systematically allocated in consecutive order to treatment with apical patency or treatment without apical patency. The study also evaluated the relationship between baseline periapical lesion volume measured on clinically indicated cone-beam computed tomography images and postoperative pain.

Conditions

Apical Periodontitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity

  Postoperative pain intensity was assessed using a 100-mm visual analog scale (VAS), where 0 mm indicated no pain and 100 mm indicated unbearable pain. Participants recorded the highest pain experienced during each predefined postoperative interval.

  8 hours, 24 hours, 3 days, 5 days, and 7 days after root canal treatment

Secondary Outcomes (2)

• Number of Participants Who Used Any Postoperative Analgesic Medication

  From completion of root canal treatment through Day 7

• Baseline Periapical Lesion Volume

  Baseline, before root canal treatment

Study Arms (2)

Apical Patency

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

No Apical Patency

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

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.

No Apical Patency

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 Erdoğan University Faculty of Dentistry, Department of Endodontics

Rize, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Periodontitis; Pain, Postoperative

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Fatma Pertek Hatipoğlu

  Recep Tayyip Erdogan University

  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: Associate Professor

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 24, 2026
• Study Start: May 22, 2025
• Primary Completion: December 25, 2025
• Study Completion: December 25, 2025
• Last Updated: August 24, 2026

Record last verified: 2026-08

Locations

TU (1)