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NCT Number: NCT07262554

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

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.

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Key information

Conditions

Apical Periodontitis Jaw Diseases Mouth Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Periapical Diseases Periapical Periodontitis Periodontal Diseases Periodontitis Postoperative Complications Signs and Symptoms Stomatognathic Diseases

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Calcium hydroxide (Ca(OH)₂)

Drug

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

N-acetylcysteine (NAC)

Drug

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

Other names: Acetylcysteine, N-Acetyl-L-cysteine

Primary outcomes

  1. Postoperative pain intensity

    Time frame: 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."

  2. Assessment of periapical healing

    Time frame: 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.

Secondary outcomes

  1. Change in the level of periapical tissues biomarkers

    Time frame: Samples will be collected from the periapical tissue fluid at two different points: before (S1) and after 7 days of administration of medications (S2).

    The biomarker levels will be measured using enzyme-linked immunosorbent assay [ELISA]. Samples of periapical tissue fluid will be taken by inserting three sterile paper points into the root canal, about 2 mm beyond the working length, and holding them in place for 1 minute. The paper points will be transferred to a 1.5-mL Eppendorf and stored at -80°C until further analysis.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Evaluation of N-acetylcysteine as an Intracanal and Adjunctive Systemic Medication in Root Canal Treatment of Necrotic Mature Teeth With Apical Periodontitis: a Randomized Controlled Clinical Trial

Acronym: NAC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 3, 2025
Registry last updated
Dec 30, 2025

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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