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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07782515
Enrollment
113
Registered
2026-08-24
Start date
2025-05-22
Completion date
2025-12-25
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apical Periodontitis

Keywords

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

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.

Detailed description

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.

Interventions

PROCEDUREApical Patency During Root Canal Treatment

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.

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.

Sponsors

Recep Tayyip Erdogan University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pain Intensity8 hours, 24 hours, 3 days, 5 days, and 7 days after root canal treatmentPostoperative 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

MeasureTime frameDescription
Number of Participants Who Used Any Postoperative Analgesic MedicationFrom completion of root canal treatment through Day 7Participants 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.
Baseline Periapical Lesion VolumeBaseline, before root canal treatmentPeriapical 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.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORFatma Pertek Hatipoğlu

Recep Tayyip Erdogan University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 25, 2026