Resolution of Pain and Swelling After the Use of Neem Leaf Extract (Azadirachta Indica) Compared to Chlorhexidine Gluconate as an Intracanal Irrigant in Necrotic Primary Molar Teeth in Children Undergoing Pulpectomy Treatment: A Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
The trial is to test the resolution of pain, swelling and other signs of periapical infection and the antimicrobial efficacy when using the neem leaf extract compared to chlorhexidine as root canal irrigant in Pulpectomy treatment for children.
详细描述
To compare the effectiveness of neem leaf extract with that of Chlorhexidine gluconate when used as an intracanal irrigant in primary molar teeth indicated for pulpectomy treatment.
P: children with primary necrotic molars indicated for pulpectomy I: Neem leaf extract (alcoholic solution). C: 2% chlorhexidine gluconate. O: Pain and swelling resolution. T:Over 12 months. S: Randomised controlled trial.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient and parent cooperation.
- •Absence of any systemic disease that would contraindicate pulp therapy.
- •Non vital molar teeth presenting with an acute or chronic periapical infection as a result of pulp necrosis ( Periapical abscess ,a sinus tract formation as a sequelae )
- •Making sure the patient is not taking an antibiotic and has not taken it for the past 2 weeks.
- •Absence of physiologic or pathologic root resorption that contraindicate pulp therapy.
- •Restorable teeth
- •Molars with at least two thirds of root remaining.
排除标准
- •Children with any condition that contraindicates pulp therapy will be excluded (rheumatic fever, infective endocarditis , leukemia , corticosteroid therapy and immunosuppressed children).
研究组 & 干预措施
Neem leaf extract
Neem leaf extract (alcoholic solution) used as an anti inflammatory , antibacterial irrigant
干预措施: Neem leaf extract (Drug)
Chlorhexidine gluconate
2% chlorhexidine gluconate intracanal irrigant solution used as an antibacterial chemical mean for canal irrigation
干预措施: Chlorhexidine gluconate (Drug)
结局指标
主要结局
Pain
时间窗: 1 year
Patient reported pain and pain on percussion , binary
Swelling
时间窗: 1 year
Visual examination ,binary
Mobility
时间窗: 1 year
Mobility test ,binary
次要结局
- Periapical pathosis(1 year)
- Bacterial load(48 hours)
研究者
Mennatallah Sameh Ahmed Farouk Abdelhamid
Principal Investigator
Cairo University