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

NCT07648862 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-06-15

No results posted yet for this study

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

Interventions

PROCEDURE

Apical Patency Technique

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

Non-Patency Technique

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

Sponsors & Collaborators

  • Bolan Medical Complex Hospital Quetta Pakistan

    lead OTHER

Principal Investigators

  • Asjed Khan Jadoon, PharmD MPhil Pharmacology · Sheikh Mohammed bin Zayd Alnahyan (Smbzan) Institute of Cardiology Quetta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2026-02-01
Completion
2026-02-01

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07648862 on ClinicalTrials.gov