Influence of Maintaining Apical Patency on Post-Endodontic Pain in Molars

NCT07239752 | Not Yet Recruiting DMC

• 1 other identifier: SCD-Endo-Patency-001
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized controlled trial will investigate if maintaining apical patency-a technique where a small file is gently moved past the root's end during cleaning-affects pain after a root canal. The study will include 48 adult patients needing root canal treatment on a back molar tooth with a dead nerve and infection at the root tip. Participants will be randomly assigned to one of two groups: one where the apical patency technique is used, and one where it is not. All other treatment steps will be identical. Patients will record their pain levels on a standard scale (0-100 mm Visual Analog Scale) at 6, 12, 24, 48, and 72 hours after the procedure. The goal is to determine if this specific technique influences the intensity and duration of post-treatment pain

Conditions

Periapical Periodontitis; Dental Pulp Necrosis

Outcome Measures

Primary Outcomes (6)

• Post-operative Pain Intensity

  Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.

  6 hours after the completion of the root canal procedure

• Post-operative Pain Intensity at 6 hours

  Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.

  6 hours after the completion of the root canal procedure.

• Post-operative Pain Intensity at 12 hours

  Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.

  12 hours

• Post-operative Pain Intensity at 48 hours

  Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.

  48 hours

• Post-operative Pain Intensity

  Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.

  12 hours after the completion of the root canal procedure

• Post-operative Pain Intensity

  Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.

  24 hours

Secondary Outcomes (2)

• ncidence of Post-operative Pain Severity

  Assessed at 6, 12, 24, 48, and 72 hours after the procedure

• ncidence of Post-operative Pain Severity

  Assessed at 6, 12, 24, 48, and 72 hours after the procedure. The data from all time points will be aggregated to compare the overall distribution of pain severity between groups.

Study Arms (2)

Patency Group

EXPERIMENTAL

: A #10 K-file is passively advanced 1.0 mm beyond the major apical foramen before and after each successive instrumentation size to maintain patency.

Procedure: Patency Group; Procedure: Standard Root Canal Instrumentation

Non-Patency Group

ACTIVE COMPARATOR

Participants in this group will receive standard root canal treatment where instruments are carefully confined to the root canal space and do not proceed beyond the apical foramen. All other aspects of the treatment are identical to the Experimental arm.

Procedure: Patency Group; Procedure: Standard Root Canal Instrumentation

Interventions

Patency Group PROCEDURE

The procedural technique of passively advancing a small endodontic file (size #10 K-file) 1 mm beyond the apical foramen before and after each larger instrument during root canal cleaning and shaping. This is done to prevent blockage of the apical portion of the canal.

Non-Patency Group; Patency Group

Standard Root Canal Instrumentation PROCEDURE

Root canal instrumentation that is strictly confined to the canal space, terminating at the apical constriction (working length) and avoiding any instrumentation beyond the apical foramen.

Non-Patency Group; Patency Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medically healthy, classified as American Society of Anesthesiologists (ASA) Physical Status I or II.
• Presence of a single permanent molar tooth diagnosed with necrotic pulp and symptomatic apical periodontitis, and indicated for primary root canal treatment.
• Patients who provide informed written consent to participate in the study. -

You may not qualify if:

• Teeth with prior endodontic treatment or complex anatomy (e.g., calcified canals, severe curvature).
• Patients with significant systemic illness (e.g., uncontrolled diabetes, immunocompromised status) or pregnancy.
• History of analgesic intake within 72 hours prior to the root canal procedure.
• Non-restorable teeth, teeth with severe periodontal disease (pocket depth \>5mm), or teeth with root fractures.

Sponsors & Collaborators

• College of Physicians and Surgeons Pakistan: lead

MeSH Terms

Conditions

Periapical Periodontitis; Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Dental Pulp Diseases; Tooth Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Faiz Rahman, BDS

CONTACT

+923451505838; faizr3702@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: post graduate trainee

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: February 10, 2026
• Primary Completion (Estimated): May 10, 2026
• Study Completion (Estimated): October 10, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share