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
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Postoperative pain intensity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mature necrotic teeth.
- •Radiographic evidence of periapical bone loss.
- •Teeth that require primary endodontic treatment.
- •Restorable teeth.
排除标准
- •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.
研究组 & 干预措施
Calcium hydroxide (Ca(OH)₂)
UltraCal XS calcium hydroxide (Ca(OH)₂) intracanal medication for 7 days
干预措施: 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
干预措施: N-Acetylcysteine (NAC) (Drug)
结局指标
主要结局
Postoperative pain intensity
时间窗: 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
时间窗: 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.
次要结局
- 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).)
研究者
Mai Hussein
Assistant lecturer
Alexandria University