CClinicalTrials.gg
Not yet recruitingNCT07648862Updated Aug 26, 2026

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

An interventional study of Apical Patency Technique and Non-Patency Technique in Asymptomatic Irreversible Pulpitis, sponsored by Bolan Medical Complex Hospital Quetta Pakistan. Not yet recruiting at 1 site in Pakistan. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Bolan Medical Complex Hospital Quetta Pakistan · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study summary

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)

Read the detailed description

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)."

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Conditions studied

  • Asymptomatic Irreversible Pulpitis
03

In context

Lead sponsor

Bolan Medical Complex Hospital Quetta Pakistan is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Apical Patency Group

    Arm 1 - Apical Patency Group (APG) A #10 K-file is passed 0.5 mm beyond working length after each rotary instrument

    Procedure: Apical Patency Technique

  • Active comparator
    Non-Patency Group

    Arm 2 - Non-Patency Group (NPG) Recapitulation confined to working length only; no instrument passed beyond apex

    Procedure: Non-Patency Technique

Interventions

  • ProcedureApical 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.

  • ProcedureNon-Patency Technique

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

06

What researchers measure

Primary outcomes

  1. Primary Outcome - Measure Presence of postoperative pain

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

    Time frame: 24 hours post-treatment

07

Study locations

1 site
  • Department of Operative Dentistry, Bolan Medical Complex Hospital Unit 2
    Quetta, Balochistan 87300, Pakistan
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References and documents

Individual participant data

Plan to share: No — No plan to share individual participant data.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07648862
Lead sponsor
Bolan Medical Complex Hospital Quetta Pakistan
Responsible party
Misbah (Dr Misbah, Bolan Medical Complex Hospital Quetta Pakistan) — Principal investigator
First posted
Jun 15, 2026
Start date
Aug 24, 2026 (estimated)
Primary completion
Nov 1, 2026 (estimated)
Completion
Nov 15, 2026 (estimated)
Last update
Aug 26, 2026

Study contacts

Dr. Misbah Principal Investigator, BDS FCPS
Contact
khanmusbah@gmail.com
+92-334-1364014
Dr Syed Attaullah Shah, BDS, Fcps
study chair · Bolan medical College sandeman Provisional hospital Quetta

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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