Ireland
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Active, not recruiting Phase 2

N-acetylcysteine for Root Canal Treatment of Necrotic Teeth With Apical Periodontitis

NCT07262554 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 2
Started
2025-11-15
Last updated
2025-12-30

Condition(s) studied

Apical Periodontitis

Investigational drug(s) / intervention(s)

Calcium hydroxide (Ca(OH)₂) →N-Acetylcysteine (NAC) →

Calcium hydroxide (Ca(OH)₂): UltraCal XS calcium hydroxide (Ca(OH)₂) intracanal medication for 7 days

N-Acetylcysteine (NAC): N-acetylcysteine (NAC) intracanal medication for 7 days and 600 mg/day oral NAC for 21 days

Study summary

A randomized controlled trial comparing the postoperative pain intensity, periapical biomarkers level, and periapical healing in patients with necrotic mature teeth and apical periodontitis treated with N-acetylcysteine (NAC), as an intracanal and adjunctive systemic medication, versus calcium hydroxide (Ca(OH)₂) intracanal medication alone.

Eligibility

Sex
ALL
Min age
16 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: * Mature necrotic teeth. * Radiographic evidence of periapical bone loss. * Teeth that require primary endodontic treatment. * Restorable teeth. Exclusion Criteria: * Immature teeth * Teeth that had been previously accessed or endodontically treated. * Teeth with periodontal pockets deeper than 4 mm. * Patients with acute apical abscess. * Patients with systemic diseases. * Pregnant females. * Patients who received antibiotic therapy within the past month. * Patient on analgesics.

Primary outcome measure(s)

  • Postoperative pain intensity — Pain will be recorded before the intervention, and patients will use the Numerical Rating Scale (NRS) to self-assess postoperative pain at 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, and 1 week.
    Postoperative pain will be assessed using the Numerical Rating Scale (NRS), which is a scale from 0 (no pain) to 10 (worst pain imaginable). Patients will be asked to choose the number that represents their pain intensity. Pain level will be assigned as follows: 0, "no pain"; 1-3, "mild pain"; 4-6, "moderate pain"; 7-10, "severe pain."
  • Assessment of periapical healing — A CBCT scan will be taken preoperatively and at six months follow-up.
    Assessment of the percentage change in lesion volume through three-dimensional (3D) reconstruction of the lesions in Cone beam computed tomographic (CBCT) scans performed preoperatively and after a six-month follow-up.

Trial sites (1)

FacilityCityRegionStatus
Faculty of Dentistry, Alexandria University Alexandria Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07262554 on ClinicalTrials.gov ↗ ← All trials in Egypt