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

Recep Tayyip Erdogan University113 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

113

Conditions

Apical Periodontitis

Interventions

Apical Patency During Root Canal TreatmentPROCEDURE

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 PatencyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Recep Tayyip Erdoğan University Faculty of Dentistry, Department of Endodontics

Rize, Turkey (Türkiye)

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Number of Participants Who Used Any Postoperative Analgesic Medication

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.

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

Baseline 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.

Time frame: Baseline, before root canal treatment

Data from ClinicalTrials.gov

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