Microbiological and Clinical Assessments of Erbium Chromium: YSGG Laser as an Adjunctive to Surgical Treatment of Chronic Periodontitis (Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 主要终点
- Clinical Assessment of Probing depth (PD).
研究概览
简要总结
Microbiological and Clinical assessment of Er,Cr:YSGG laser in conjunction to open flap debridement (OFD) in treatment of chronic periodontitis through real time PCR assay for quantification of total bacterial load.
详细描述
Two groups are randomly allocated (random number generation) by Microsoft excel into two groups :
- Group (1) Open Flap debridement (OFD) surgery after conventional periodontal therapy (Scaling &Curettage and root planing) combined by Er,Cr:YSGG Laser assisted pocket therapy (ELAPT) which will be applied to pocket epithelial lining and root surface.
- Group (2) Open Flap debridement (OFD) surgery after conventional periodontal therapy (Scaling &Curettage and root planing) will be performed.
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)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients are diagnosed to have chronic periodontitis, having infrabony posterior periodontal pocket measuring 5 mm or more.
- •female or male.
- •25 - 55 years.
- •Medically controlled according to medical coding of review of systems .
- •Patient without history of drug administration in last month .
- •Exclusion criteria:
- •Tobacco smoking.
- •Pregnancy.
- •Patients not follow periodontal hygienic instructions.
- •Patients under any medication that affect periodontal healing.
- •The presence of any systemic disease that affect periodontal healing.
排除标准
- 未提供
结局指标
主要结局
Clinical Assessment of Probing depth (PD).
时间窗: 6 months
measured by milli meters for detection of level of periodontal destruction.
Clinical Assessment of Plaque index(PI)
时间窗: 6 months
Visual Analog Score for plaque for detection amount of plaque accumulation so assess patient oral hygiene. recording is based on both soft and mineralized debris. Each surface will have a score from 0 to 3. 0: no plaque 1. plaque only detected by probe. 2. Moderate deposits detected by naked eye. 3. heavy deposits detected by naked eye.
Clinical Assessment of Gingival recession(GR)
时间窗: 6 months
measured by milli meters for detection of level of apical migration of gingival attachment.
Clinical Assessment of Gingival index(GI) to assess gingival inflammation. 0: normal gingiva. 1: mild inflammation . 2: moderate inflammation . 3: sever inflammation marked redness and edema and spontaneous bleeding.
时间窗: 6 months
Visual Analog Score for gingival inflammation
Clinical Assessment of Clinical attachment level (CAL) .
时间窗: 6 months
measured by milli meters for detection of level of periodontal destruction.
Clinical Assessment of Modified sulcular bleeding index (MSBI)
时间窗: 6 months
Visual Analog Score of bleeding for detection of inflammatory status level. Modified Sulcus Bleeding Index(MSBI) 0 = No bleeding on bleeding. 1. =pin pointed bleeding. 2. = linear bleeding. 3. = Heavy or profuse bleeding.
次要结局
- Microbiological assessment through real time PCR assay for quantification of total bacterial load by universal probe and primer set (16sr RNA)(3 months)
研究者
alaa
Teaching Assistant
Ain Shams University