Asymptomatic Irreversible Pulpitis
Conditions
Brief 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)
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)."
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.
Sponsors
Bolan Medical Complex Hospital Quetta Pakistan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants receive root canal treatment either with or without apical patency.
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome - Measure Presence of postoperative pain | 24 hours post-treatment | Postoperative pain assessed using the Numerical Rating Scale (NRS), categorized as present (NRS ≥1) or absent (NRS = 0) |
Countries
Pakistan
Contacts
CONTACTDr. Misbah Principal Investigator, BDS FCPS
STUDY_CHAIRDr Syed Attaullah Shah, BDS, Fcps
Bolan medical College sandeman Provisional hospital Quetta
Outcome results
None listed