Clinical, Radiographical and Microbiological Evaluation of Chitosan as Irrigating Solution for Pulpectomy in Non-Vital Primary Teeth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Spontanous Pain
研究概览
简要总结
45 teeth will be sub-divided at random with a computerized method, according to the type irrigant and duration of its application into 3 groups (15 teeth in each group):
Group1(control group):
The teeth will be irrigated by 2 ml 1% NaOCl after each file.
Group2:
The teeth will be irrigated by 2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for one minute.
Group 3:
The teeth will be irrigated by 2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for 3 minutes.
Evaluation
Clinical evaluation will be done for all groups at one, three, six and 12 months. The following parameters will be evaluated: Pain (spontaneous pain and pain with percussion) Degree of mobility Resolution of signs of infection (fistula) at the mucobuccal fold.
Radiographical evaluation will be performed to each patient immediately after the final restoration and three, six and 12 months postoperatively.
The decrease of radiolucency and the presence of internal or external root resorption will be evaluated.
Bacteriology :
The microbiological evaluation will be done at the Biotechnology Research Institute - Suez Canal University.
PCR will be used for detection of Enterococcus faecalis. Microbiological investigation will be used for counting the number of Enterococcus faecalis.
详细描述
45 teeth will be sub-divided at random with a computerized method, according to the type irrigant and duration of its application into 3 groups (15 teeth in each group):
Group1(control group):
The teeth will be irrigated by 2 ml 1% NaOCl after each file.
Group2:
The teeth will be irrigated by 2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for one minute.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 7 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Apparently healthy Children aged from three to seven years.
- •No previous history of antibiotics for at least two weeks.
- •Non- Vital primary teeth that can be fully isolated.
- •Presence of clinical signs or symptoms suggesting a non-vital tooth, such as intra-oral fistula.
- •Infection diagnosed by presence of periapical radiolucency in a periapical radiograph.
- •Root resorption not more than one third of the root.
- •Patient and parent cooperation.
排除标准
- •Non-restorable tooth
- •Serious reduction in bone support and/or extreme tooth mobility.
- •Radiographic indication of extensive internal or external root resorption.
结局指标
主要结局
Spontanous Pain
时间窗: after one month, 3 months, six months and 12 months
Visual analog scale "A scale from 1 to 10 where 1 is mild pain and 10 Worst pain"
Radiographic examination " internal or external root resorption"
时间窗: immediately after restoration, 3 months, six months and 12 months
Presence (1) or absence (0)
Radiographical evaluation
时间窗: immediately after restoration, 3 months, six months and 12 months
The change of radiolucency
Bacteriology
时间窗: During procedure
PCR will be used for detection of Enterococcus faecalis. \- Microbiological investigation will be used for counting the number of Enterococcus faecalis
次要结局
未报告次要终点