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NCT Number: NCT07782515

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Recep Tayyip Erdoğan University Faculty of Dentistry, Department of Endodontics

Rize, Turkey (Türkiye)

About this study

Eligible participants received standardized single-visit root canal treatment under local anesthesia and rubber dam isolation. In the apical patency group, a #10 stainless-steel K-file was passively advanced approximately 0.5-1 mm beyond the working length after each rotary instrument without intentional apical enlargement or dentin removal. In the no-apical-patency group, canal preparation was confined to the working length and no instrument was intentionally extended beyond the apical foramen. Conventional randomization was not used. To maintain numerical balance during enrolment, a systematic consecutive allocation approach was used, whereby apical patency was performed in one case and not performed in the subsequent case. Participants were aware of the treatment approach. Postoperative pain was assessed with a 100-mm visual analog scale at 8 hours, 24 hours, 3 days, 5 days, and 7 days. Analgesic use was also recorded. Periapical lesion volume was measured in cubic millimeters using manual three-dimensional segmentation with ITK-SNAP on eligible CBCT images obtained for clinical purposes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Postoperative Pain Intensity

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

    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.

Secondary outcomes

  1. Number of Participants Who Used Any Postoperative Analgesic Medication

    Time frame: From completion of root canal treatment through Day 7

    Participants were classified as having postoperative analgesic use if they reported taking at least one dose of any analgesic medication after root canal treatment during the 7-day follow-up period. The outcome was assessed as the number of participants with any postoperative analgesic use in each treatment arm.

  2. Baseline Periapical Lesion Volume

    Time frame: Baseline, before root canal treatment

    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.

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University

Other

Registry information

Official study title

Effect of Apical Patency and Periapical Lesion Volume on Postoperative Pain: A CBCT-Based Volumetric Clinical Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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