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
Overview
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Alexandria University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Postoperative pain intensity
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 16 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Calcium hydroxide (Ca(OH)₂)
UltraCal XS calcium hydroxide (Ca(OH)₂) intracanal medication for 7 days
Intervention: Calcium hydroxide (Ca(OH)₂) (Drug)
N-acetylcysteine (NAC)
N-acetylcysteine (NAC) intracanal medication for 7 days and 600 mg/day oral NAC for 21 days
Intervention: N-Acetylcysteine (NAC) (Drug)
Outcomes
Primary Outcomes
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."
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
- 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).)
Investigators
Mai Hussein
Assistant lecturer
Alexandria University