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NCT Number: NCT07648862

Comparing Post Operative Pain With and Without Apical Patency Technique in Asymptomatic Irreversible Pulpitis Teeth

Primary Outcome - Measure Presence of postoperative pain Primary Outcome - Time Frame 24 hours post-treatment Primary Outcome - Description Postoperative pain assessed using the Numerical Rating Scale (NRS), categorized as present (NRS ≥1) or absent (NRS = 0)

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Operative Dentistry, Bolan Medical Complex Hospital Unit 2

Quetta, Balochistan, 87300, Pakistan

About this study

Apical patency is a root canal preparation technique in which a small flexible K-file is passively passed just beyond the apical foramen to maintain canal permeability and prevent apical debris accumulation. Although this method improves irrigation flow to the apical third and reduces the risk of canal blockage, ledge formation, and transportation, its association with postoperative pain remains debatable. This randomized clinical trial aims to compare the frequency of postoperative pain between two treatment protocols in patients with asymptomatic irreversible pulpitis involving maxillary or mandibular premolars. Participants will be randomly allocated into two equal groups. In the Apical Patency Group (APG), a pre-curved #10 K-file will be gently passed 0.5 mm beyond the radiographic working length after each rotary instrument, without filing motion. In the Non-Patency Group (NPG), instrumentation and recapitulation will be strictly confined to the established working length, with no instrument intentionally passing beyond the apex. All procedures will be performed under standard endodontic protocols using rubber dam isolation, 2% lidocaine anesthesia, and 3% sodium hypochlorite irrigation. Postoperative pain severity will be self-assessed by patients using the 11-point Numerical Rating Scale (NRS) at 24 hours post-treatment. The primary outcome will be the presence or absence of pain, while secondary analysis will explore pain intensity categories (mild, moderate, severe)."

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 20-50 years; maxillary or mandibular first/second premolar; diagnosed with asymptomatic irreversible pulpitis (no history of spontaneous pain; caries extending ≥2/3 into dentine; no tenderness to percussion/palpation; exaggerated, prolonged response to pulp vitality testing - cold, hot, or EPT)

Exclusion criteria

Uncontrolled diabetes mellitus; uncontrolled hypertension; bleeding disorder; use of anticoagulant therapy; active peptic ulcer; ischemic heart disease; compromised hepatic or renal function; immature apex; internal or external root resorption; blocked or sclerosed canal; periapical radiolucency; acute apical periodontitis; grade 3 mobility; root fracture; teeth in which patency cannot be maintained; symptomatic irreversible pulpitis; non-restorable teeth; retreatment cases

Treatment and study plan

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.

Non-Patency Technique

Procedure

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

Primary outcomes

  1. Primary Outcome - Measure Presence of postoperative pain

    Time frame: 24 hours post-treatment

    Postoperative pain assessed using the Numerical Rating Scale (NRS), categorized as present (NRS ≥1) or absent (NRS = 0)

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Misbah Principal Investigator, BDS FCPS

CONTACT

[email protected]

+92-334-1364014

Sponsors and collaborators

Lead sponsor

Bolan Medical Complex Hospital Quetta Pakistan

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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