The Effect of Apical Patency on Postoperative Pain Following Root Canal Treatment

Not Applicable

Completed

• Conditions: Postoperative Pain After Endodontic Treatment

• Registration Number: NCT07233590
• Lead Sponsor: Cukurova University

Brief Summary

The goal of this randomized controlled clinical trial was to evaluate whether implementing apical patency affects the intensity of postoperative pain after single-visit root canal treatment in asymptomatic, vital, single-rooted teeth.

The main question it aims to answer is:

Does maintaining apical patency by gently extending a #10 K-file 1 mm beyond the working length during canal shaping influence postoperative pain compared with instrumentation confined within the working length?

In the patency group, the working length was determined with an electronic apex locator and radiograph, and then apical patency was maintained by passively extending a #10 K-file 1 mm beyond the working length at each instrument change to prevent apical blockage, remove debris, and facilitate irrigant delivery to the apical terminus.

In the non-patency group, the working length was likewise established with an electronic apex locator and radiograph, but all subsequent instrumentation was confined within the working length and no file was advanced beyond the apical foramen.

In both groups, all other clinical procedures-including anesthesia, rubber dam isolation, access cavity preparation, rotary canal shaping with the One Curve NiTi system, standardized irrigation with 2.5% NaOCl and 17% EDTA, obturation with gutta-percha and epoxy resin-based sealer, and definitive composite restoration-were performed in a single visit using the same protocol. Postoperative pain was recorded on a Numerical Rating Scale (NRS) at 0-6, 6-12, 12-24, 24-36, and 36-48 hours, and analgesic intake within 48 hours was documented.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-05
• Primary Completion: 2024-12-14
• Study Completion: 2025-02-10
• Status Verified: 2025-11
• Study First Submitted: 2025-11-14
• Study First Submitted QC: 2025-11-14
• Last Update Submitted: 2025-11-14
• Study First Posted: 2025-11-18
• Last Update Posted: 2025-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Individuals aged 18-65 years, classified as ASA I or ASA II according to the American Society of Anesthesiologists (ASA), who had not taken analgesics for at least 6 hours prior to treatment.
• Asymptomatic, single-rooted vital teeth without spontaneous pain (including teeth perforated during prosthetic preparation or teeth adjacent to a cyst in an area scheduled for cyst surgery).
• Radiographic evidence of mature apices with no periapical pathology; periodontal probing depth ≤ 3 mm; and gingival health meeting Glickman's criteria.
• Individuals who are literate, able to provide written informed consent, and capable of understanding and using the pain scale.

Exclusion Criteria

• Patients who are pregnant or have a cardiac pacemaker.
• Patients who used antibiotics within the past month or who required antibiotic prophylaxis.
• Presence of extensive restorations in the tooth of interest.
• Patients reporting concurrent pain in adjacent teeth.
• Dental or orofacial pain of non-endodontic origin.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Numerical Rating Scale (NRS)	Up to 48 hours after treatment.	The numerical rating scale for pain is an 11-point scale from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable. The patient is asked to choose the number that best represents the intensity of pain he or she feels at that moment. It is used to assess the severity of postoperative pain and to help evaluate the need for and response to analgesic medication. Also called NRS.

Trial Locations

Locations (1)

Cukurova University; Adana, Sarıçam, Turkey (Türkiye)