Recep Tayyip Erdoğan University Faculty of Dentistry, Department of Endodontics
Rize, Turkey (Türkiye)
NCT Number: NCT07782515
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Rize, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Recep Tayyip Erdogan University
Other
Effect of Apical Patency and Periapical Lesion Volume on Postoperative Pain: A CBCT-Based Volumetric Clinical Study
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