Evaluation of the Effect of Systemic Proteolytic Enzyme Therapy on Postoperative Inflammatory Response and Quality of Life After Surgical Extraction of Impacted Mandibular Third Molars
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Pain after surgery
研究概览
简要总结
- To compare the postoperative pain between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day.
- To compare the postoperative swelling (edema) between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day.
- To compare the degree of trismus between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day.
- Measure patients' perceptions of changes in their quality of life in the postoperative period and compare it between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day.
详细描述
Evaluation of the effect of systemic proteolytic enzyme therapy on postoperative inflammatory response and quality of life after surgical extraction of impacted mandibular third molar.
The aim of this study is to evaluate the effect of systemic enzyme therapy(TibrolinTM) on the postoperative inflammatory response and the quality of life after surgical removal of impacted third molar. The study is designed and was implemented as a randomized controlled clinical study guided by Consolidated Standards of Reporting Trials (CONSORT) guidelines . Patients were randomly allocated to two groups (25patients per group). Group A included administration of SET after surgery and continued for 5 days post-surgery; Group B, a control group that would not receive the systemic enzyme therapy . The predictor variable was The use of systemic proteolytic enzyme (Tibrolin) or not .The primary outcome variables were pain and swelling , trismus,quality of life measured on 1st day (day of surgery), third day, and 7th after surgery.
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 (Participant)
盲法说明
metronidazol 500 mg 1bythree amoxicillin 500 mg 1by three doulprane 1000 mg one by one
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy patients over 18 years old of either gender.
- •Patients who have impacted mandibular third molar.
- •Ability to tolerate surgical procedure.
- •Pell and Gregory's classification (Class I and class II, position A and B).
排除标准
- •Patients with uncontrolled systemic diseases.
- •Patients with history of chemotherapy or radiotherapy therapy to the head and neck region.
- •Acute infection at the surgical site at time of operation.
- •The presence of cysts or tumors associated with the impacted teeth.
- •Pell and Gregory's classification (class III Position C)
研究组 & 干预措施
systemic proteolytic enzyme
Tibrolin combination of (Trypsin 48 mg, Bromelain 90 mg) and a bioflavonoid (Rutoside 100 mg) one by one for five day
干预措施: systemic proteolytic enzyme (Tibrolin) (Drug)
amoxicillin, metronidazol, doliprane
amoxicillin 500 mg one by three metronidazol 500 mg one by three doulprane 1000 mg one by one
干预措施: Amoxicillin 500mg+metronidazole 500mg+ doliprane 100mg (Drug)
结局指标
主要结局
Pain after surgery
时间窗: 7 Days
pain will be measured on pain rating scale form 0 to 10
Facial swelling
时间窗: 7 Days
swelling will be determined by distance between 3 points
Trismus
时间窗: 7 Days
the degree of trismus will be measured by maximum mouth opening
次要结局
未报告次要终点
研究者
Dunya Abdulmuniem
Principal investigator
University of Baghdad