The Use of 2% Chlorhexidine Gluconate With Mineral Trioxide Aggregate in Indirect Pulp Treatment of Primary Molars: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Data Recording Sheet for Intraoral Clinical Examination
研究概览
简要总结
The aim of this study was to compare the clinical and radiographic success rates of indirect pulp treatment (IPT) performed by combining 2% chlorhexidine gluconate with mineral trioxide aggregate (MTA) versus IPT performed with MTA in children's vital primary molars. A randomized, split-mouth design including 40 children aged 4-8 years was implemented. The study sample composed of 80 primary molars with deep carious lesions. Each child had 1 pair, one tooth from each pair was allocated randomly either to the 2% chlorhexidine gluconate/MTA group or the MTA group. All teeth were restored with stainless steel crowns. Follow-up is carried out to evaluate the teeth clinically and radiographically.
详细描述
A double blinded, randomized, controlled clinical trial was performed in a split-mouth design. Eighty primary molars in forty subjects were randomly allocated that each subject had one tooth treated with 2% chlorhexidine gluconate and MTA (experimental group), and the other tooth treated with only MTA (control group).
The study was held at King Abdulaziz University Dental Hospital (KAUDH), Jeddah. Forty healthy children with the age range 4- to 8-year-old were included. Each patient had at least two first primary molars or two second primary molars with deep occlusal or proximal caries not approaching the pulp indicated for IPT.
Preoperative periapical radiographs of the teeth considered for treatment in the study were made using extension cone paralleling technique in the x ray machine.
The procedure was performed in two visits by one operator to allow for the setting of MTA. Stainless steel crowns were used as final restorations.
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
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient inclusion criteria:
- •4-8 years old.
- •Cooperative.
- •Had at least two first primary molars or two second primary molars with deep occlusal or proximal caries not approaching the pulp indicated for IPT.
- •Teeth inclusion criteria:
- •No spontaneous pain.
- •No pain on palpation or percussion.
- •No signs of fistula or abscess.
- •No abnormal mobility.
- •No radiolucency at the periapical or interradicular areas.
- •No loss of lamina dura.
- •No radiographic signs of internal resorption.
- •Sufficient tooth structure allowing placement of rubber dam.
- •Not expected to exfoliate within 1 year.
排除标准
- •Spontaneous pain.
- •Pain on palpation or percussion.
- •Signs of fistula or abscess.
- •Presence of abnormal mobility.
- •Radiolucency at the periapical or interradicular areas.
- •Loss of lamina dura.
- •Radiographic signs of internal resorption.
- •No sufficient tooth structure allowing placement of rubber dam.
- •Expected to exfoliate within 1 year.
结局指标
主要结局
Data Recording Sheet for Intraoral Clinical Examination
时间窗: 12 months
Data sheet for recording the clinical outcome criteria obtained by intraoral clinical examination is filled by the investigators. The data sheet includes information regarding the presence or absence of the following: 1. Spontaneous pain. 2. Pain on percussion. 3. Signs of abscess or fistula. 4. Abnormal mobility. The response for each point is interpreted in the form by either "yes" or "no".
Data Recording Sheet for Periapical Radiographic Evaluation
时间窗: 12 months
Data sheet for recording the radiographic outcome criteria obtained from periapical radiograph is filled by the investigators. The data sheet includes information regarding the presence or absence of the following: 1. Radiolucency at the periapical or interradicular areas. 2. Loss of lamina dura. 3. Signs of internal root resorption. 4. Signs of external pathologic root resorption. 5. Normal root resorption accompanying the exfoliation process. The response for each point is interpreted in the form by either "yes" or "no".
次要结局
未报告次要终点
研究者
Afnan Saber
Principle investigator
King Abdulaziz University