Assessment of Topical Application of Chitosan 0.2% Chlorhexidine Gel on Wound Healing Following Mandibular Trans-alveolar Molar Extraction in Diabetic Patients: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Early Wound Healing Score (EHS)
研究概览
简要总结
Despite efforts to prevent postoperative discomfort, immediate side effects of surgical extraction of lower molars include bleeding at the site of extraction, inflammation, pain, and alveolar osteitis especially in diabetic patients Bexident Post is a topical gel commercialized by ISDIN labs (ISDIN, Spain) that contains chitosan, 0.2% chlorhexidine, allantoin and dexpanthenol. it has hemostatic, antimicrobial, wound healing properties and proven antiseptic effect.
详细描述
The aim of this study is to Evaluate whether the Chitosan + 0.2% CHX gel improves healing after extraction in diabetic patients Material and Methods The main inclusion criteria for this prospective, randomized, double-blinded clinical study will be adults with controlled diabetes (HbA1c <7) in need of surgical extraction of mandibular molars.
Equal randomization was achieved for 40 patients with the use of a computer-generated random number list, the patient will be divided into two groups , 20 patients for study group and 20 patients for control group. and signed inform consent will be obtained from every patient included in the study .
Surgical extraction of the offending tooth will be performed under local anesthesia using inferior alveolar nerve block technique with buccal mucosa infiltration, make an incision on the gingival tissue (envelop flap) and , make bone guttering reduction and tooth sectioning and tooth is removed using dental elevators. Study Group: Socket filled with Chitosan + 0.2% CHX gel.
Control Group: No gel, standard instructions only.
Primary outcome measures :
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults with controlled diabetes (HbA1c <7
- •Mandibular molar extraction indicated
排除标准
- •Immunocompromised, allergyto Chitosan/CHX.
研究组 & 干预措施
Surgical extraction of the offending tooth will be performed under local anesthesia using inferior a
Surgical extraction of the offending tooth will be performed under local anesthesia using inferior alveolar nerve block technique with buccal mucosa infiltration, make an incision on the gingival tissue (envelop flap) and , make bone guttering reduction and tooth sectioning and tooth is removed using dental elevators. control group : only instruction no gel will be used
干预措施: Surgical extraction of the offending tooth will be performed under local anesthesia using inferior alveolar nerve block technique with buccal mucosa infiltration, make an incision on the gingival tis (Procedure)
结局指标
主要结局
Early Wound Healing Score (EHS)
时间窗: 3 days,1 week, 2 weeks, 1 month
The Early Wound Healing Score (EHS) is a 0-10 point clinical tool designed to objectively assess the quality of periodontal soft tissue healing
Visual analog scale
时间窗: 3 days,1 week, 2 weeks, 1 month.
0 represent no pain and 10 represenet severe pain
Swelling
时间窗: 3 days,1 week, 2 weeks, 1 month
Intraoral swelling score (Edema)
次要结局
未报告次要终点
研究者
Mohamed Kamal Eid Allam
Assistant Professor
Tanta University