Innovative Clean-Seal Technique Incorporating Sodium Hypochlorite and Hyaluronic Acid as an Adjunct to Non-Invasive Therapy for Stage III Periodontitis Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Plaque accumulation
研究概览
简要总结
The study was designed to evaluate the concept of the clean & seal, using sodium hypochlorite gel and hyaluronic acid as adjunctive to non-surgical therapy for management of Stage III Periodontitis.
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
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes diagnosed with periodontitis Stage III.
- •CAL ≥ 5mm or bone loss affecting middle third of the root in more than two adjacent teeth.
- •PPD ≥ 6mm in more than two adjacent teeth.
- •Periodontal tooth loss ≤ 4 teeth.
- •Systemically healthy patients.
排除标准
- •Patient with uncontrolled diabetes.
- •Pregnant or lactating.
- •Tobacco smoker ≥ 10 cigarettes/day.
- •Antibiotic treatment within previous 4 weeks.
- •Acute periodontal or periapical abscess
研究组 & 干预措施
Scaling and root planing
干预措施: Scaling and root planing (Procedure)
Scaling and root planing with sodium hypochlorite and hyaluronic acid
干预措施: Scaling and root planing with sodium hypochlorite and hyaluronic acid (Other)
结局指标
主要结局
Plaque accumulation
时间窗: up to 12 weeks
This was assessed using O'Leary plaque index. The O'Leary Plaque Index records the presence or absence of dental plaque on four surfaces (mesial, distal, buccal, lingual) of each tooth. The score ranges from 0% (no plaque) to 100% (plaque on all surfaces), with lower percentages indicating better oral hygiene.
Gingival condition assessment
时间窗: up to 12 weeks
The Gingival Index of Löe and Silness was used to assess the severity of gingival inflammation based on color, consistency, and bleeding on probing across four areas per tooth. Scores range from 0 (normal gingiva) to 3 (severe inflammation with spontaneous bleeding), with higher scores indicating worse gingival health.
次要结局
- Probing depth(up to 12 weeks)
- Clinical attachment loss(up to 12 weeks)
研究者
Karim Ismail
MSc. candidate in the diagnosis, oral medicine & periodontology department
Alexandria University