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

NCT07262554 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: 9258326PACTR202511513893768
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Apical Periodontitis

Keywords

N-acetylcysteine (NAC); Calcium hydroxide (Ca(OH)₂); Intracanal medication; Root canal treatment; Apical periodontitis; Postoperative pain; Periapical healing; Periapical tissue biomarkers; Cone-beam computed tomography (CBCT)

Outcome Measures

Primary Outcomes (2)

• Postoperative pain intensity

  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."

  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.

• Assessment of periapical healing

  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.

  A CBCT scan will be taken preoperatively and at six months follow-up.

Secondary Outcomes (1)

• Change in the level of periapical tissues biomarkers

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

Study Arms (2)

Calcium hydroxide (Ca(OH)₂)

ACTIVE COMPARATOR

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

Drug: Calcium hydroxide (Ca(OH)₂)

N-acetylcysteine (NAC)

EXPERIMENTAL

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

Drug: N-Acetylcysteine (NAC)

Interventions

N-Acetylcysteine (NAC) DRUG

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

Also known as: Acetylcysteine, N-Acetyl-L-cysteine

N-acetylcysteine (NAC)

Calcium hydroxide (Ca(OH)₂) DRUG

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

Calcium hydroxide (Ca(OH)₂)

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Mature necrotic teeth.
• Radiographic evidence of periapical bone loss.
• Teeth that require primary endodontic treatment.
• Restorable teeth.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

MeSH Terms

Conditions

Periapical Periodontitis; Pain, Postoperative

Interventions

Calcium Hydroxide; Acetylcysteine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Two blinded and trained researchers, not involved in the intervention, will independently assess the pre- and postoperative radiographs. A blinded assessor will also perform the data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: Participants will be randomly assigned to one of two groups. Group I (control group): UltraCal XS calcium hydroxide (Ca(OH)₂) intracanal medication for 7 days; and Group II: N-acetylcysteine (NAC) intracanal medication for 7 days and 600 mg/day oral NAC for 21 days.

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 3, 2025
• Study Start: November 15, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)