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

Phase 2Active Not RecruitingNCT07262554

Alexandria University40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Apical Periodontitis

Interventions

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

Eligibility

Sex: ALLMin age: 16 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Outcomes

Primary Outcomes

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."

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.

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.

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

Secondary Outcomes

Change in the level of periapical tissues biomarkers

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.

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).

Data from ClinicalTrials.gov

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