Comparison of Post-Operative Pain With and Without Apical Patency in Asymptomatic Irreversible Pulpitis: A Randomized Controlled Trial

NCT07648862 | Completed DMC

• 1 other identifier: BolanMed
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares post-operative pain in teeth with asymptomatic irreversible pulpitis treated with versus without apical patency during root canal treatment. Asymptomatic irreversible pulpitis is a condition where the dental pulp is inflamed but the patient does not feel spontaneous pain. Apical patency is a technique where a small flexible file is passed gently beyond the tip of the tooth root during cleaning and shaping. One hundred fifty patients with premolar teeth diagnosed with asymptomatic irreversible pulpitis were randomly assigned to one of two groups. The Apical Patency Group received root canal treatment with a #10 K-file passed 0.5 mm beyond the working length after each rotary instrument. The Non-Patency Group received the same treatment but no instrument was passed beyond the working length. The primary outcome is pain incidence at 24 hours measured on a Numerical Rating Scale (0 to 10, where 0 is no pain and 10 is worst pain imaginable). Secondary outcomes include pain intensity at 6,12,24,48,72 hours, number of ibuprofen tablets taken for pain, and time until pain completely resolves. The study aims to determine whether the apical patency technique reduces post-operative pain compared to standard treatment without patency.

Conditions

Condition: Asymptomatic Irreversible Pulpitis Synonym (if Asked): Asymptomatic Irreversible Pulpitis of Premolar Teeth

Outcome Measures

Primary Outcomes (1)

• Pain Incidence at 24 Hours

  Proportion of participants reporting any post-operative pain (Numerical Rating Scale score ≥1) at 24 hours after root canal treatment. The Numerical Rating Scale is an 11-point scale from 0 (no pain) to 10 (worst pain imaginable).

  24 hours after completion of root canal treatment

Secondary Outcomes (2)

• Intensity Over Time

  6, 12, 24, 48, and 72 hours after completion of root canal treatment

• 6, 12, 24, 48, and 72 hours after completion of root canal treatment

  Up to 72 hours after completion of root canal treatment

Study Arms (2)

Apical Patency Group

EXPERIMENTAL

After each rotary instrument, a pre-curved #10 K-file was passively passed 0.5 mm beyond the working length. No filing motion was performed.

Procedure: Apical Patency Technique

Non-Patency Group

ACTIVE COMPARATOR

No instrument was intentionally passed beyond the working length. Recapitulation was performed only to the working length.

Procedure: Non-Patency Technique

Interventions

Apical Patency Technique PROCEDURE

After each rotary instrument, a pre-curved #10 K-file was passively passed 0.5 mm beyond the working length. No filing motion was performed.

Apical Patency Group

Non-Patency Technique PROCEDURE

No instrument was intentionally passed beyond the working length. Recapitulation was performed only to the working length.

Non-Patency Group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Age 20 to 50 years
• American Society of Anesthesiologists Physical Status I or II
• Maxillary or mandibular first or second premolar requiring non-surgical root canal treatment
• Confirmed asymptomatic irreversible pulpitis (deep caries, prolonged cold test response ≥10 seconds, no spontaneous pain, no periapical radiolucency)
• Written informed consent obtained

You may not qualify if:

• \- Uncontrolled diabetes (HbA1c \>7%) or uncontrolled hypertension
• Chronic pain syndromes or immunosuppression
• Analgesic/corticosteroid/antidepressant use within 2 weeks
• Immature apex, root resorption, root fracture, or curvature \>30 degrees
• Calcified canals, pocket depth \>4 mm, mobility \>Grade I, or non-restorable crown
• Retreatment cases or inability to achieve anesthesia
• Pregnancy

Sponsors & Collaborators

• Bolan Medical Complex Hospital Quetta Pakistan: lead

Study Sites (1)

Department of Operative Dentistry, Bolan Medical Complex Hospital Unit 2

Quetta, Balochistan, 87300, Pakistan

Location

Study Officials

• Asjed Khan Jadoon, PharmD MPhil Pharmacology

  Sheikh Mohammed bin Zayd Alnahyan (Smbzan) Institute of Cardiology Quetta

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant and Outcomes Assessor (Select "Single Blind" if that is the only option, or check both "Participant" and "Outcomes Assessor" if the form allows multiple selections)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Misbah

Model Details: Participants receive root canal treatment either with or without apical patency.

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 15, 2026
• Study Start: June 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)