Nitazoxanide as a New Local Adjunctive to Nonsurgical Treatment of Moderate Periodontitis: Clinical and Biochemical Evaluation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Probing depth
研究概览
简要总结
The aim of the study was to assess the effect of nitazoxanide delivered subgingivally as thermosensitive hydrogel on the clinical and biochemical outcomes of SRP in patients with moderate periodontitis.
详细描述
A randomized, controlled clinical trial in a split-mouth design was conducted on forty patients equally divided between two groups: a control group treated with full mouth scaling and root planing (SRP) and a test group treated with SRP combined with subgingivally delivered 0.01% NTZ sustained release Poloxamer 407/hyaluronic acid thermosensitive hydrogel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having probing depth (PD) ≥5 mm.
- •Patients having bleeding on probing (BOP) in proximal tooth surface.
- •Patients who could maintain an O'Leary plaque index ≤10 proceeded into the study.
排除标准
- •Patients having any systemic disease that may affect the treatment outcomes.
- •Pregnant females.
- •Patients receiving contraindicated medications, chemotherapy, or radiotherapy in the previous year.
研究组 & 干预措施
Scaling and Root Planing (SRP)
干预措施: Scaling and Root Planing (Procedure)
Scaling and Root Planing with Nitazoxanide hydrogel
干预措施: Nitazoxanide hydrogel (Drug)
结局指标
主要结局
Probing depth
时间窗: up to 6 months
Probing depth was recorded at tested sites with graduated William's probe graduated in 1 mm increment. Readings were rounded to the nearest mm.
Bleeding on probing
时间窗: up to 6 months
Bleeding on probing was assessed at tested sites with graduated William's probe graduated in 1 mm increment, within 15 seconds after probing, using a dichotomous scoring system (+ and -) for presence or absence, respectively.
Clinical attachment loss
时间窗: up to 6 months
Clinical attachment loss was recorded at tested sites with graduated William's probe graduated in 1 mm increment. Readings were rounded to the nearest mm.
Biochemical assessment of inflammation
时间窗: up to 6 months
This involved determination of the gingival crevicular fluid (GCF) levels of matrix metalloproteinase 8 (MPP-8). A GCF sample was taken from the area showing the deepest pocket depth around the treated area.The samples were diluted in phosphate buffer saline (PBS) up to 1 mL. After waiting for 15 min, the paper points were removed, and 500 μL were centrifuged at 400 g for 4 min, then frozen at -20°C pending MMP-8 analysis using Human Matrix metalloproteinase 8/Neutrophil collagenase (MMP-8) ELISA Kit according to the manufacturer instructions.
Gingival index
时间窗: up to 6 months
Gingival index was assessed at 4 sites on six index teeth. Scores range from 0 to 3, with 0 being normal and 3 being severe inflammation
次要结局
未报告次要终点
研究者
Maha Talaab
Associate Professor, Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology department
Alexandria University