Clinical and Radiographic Evaluation of Hyaluronic Acid and Biodentine as Vital Pulpotomy Medications in Primary Molars: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- clinically successful pulpotomy
研究概览
简要总结
Evaluate clinically and radiographically the effect of biodentine and hyaluronic acid (HA) versus formocresol (FC) as pulpotomy medications in primary molars.
详细描述
Split mouth randomized controlled clinical trial. This study will be conducted on 96 teeth from 48 children in age group 4-7 years and have bilateral lower primary molars indicated for vital pulpotomy procedure. for:
- Clinical evaluation of biodentine, hyaluronic acid and formocresol groups according to presence of failure criteria at different follow up periods.
- Radiographic evaluation of biodentine, hyaluronic acid and formocresol groups according to presence of failure criteria at different follow up periods.
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, Investigator)
盲法说明
the observer and the recipients will be blinded to the study group to avoid bias (double blind randomized controlled trial)
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •-Clinical criteria
- •Restorable mandibular primary molars with deep carious lesions.
- •Absence of gingival swelling or sinus tract.
- •Absence of spontaneous pain
- •Absence of pain on percussion. B-Radiographic Criteria: Absence of
- •Discontinuity of lamina dura
- •Internal root resorption.
- •External root resorption.
- •inter-radicular or periapical bone destruction (radiolucency)
排除标准
- •Excessive bleeding during pulp amputation.
- •Non vital/necrotic teeth.
- •Any sort of medical history contraindicating the pulp treatment.
- •Teeth approximate exfoliation
- •Patient's guardians are not intending to be part of the study.
- •Retreatment of previously pulpotomy treated molar -
研究组 & 干预措施
control: Formocresol
Teeth will be treated by using squeezed sterile cotton pellet with 20% formcresol for 1 minute then removed and pulp stumps will be dressed with a layer of zinc oxide-eugenol (ZOE) paste.
干预措施: Formocresol (Drug)
Group A : (Biodentine)
The biodentine mix will be prepared according to the manufacturer's instructions and condensed lightly with a condenser on the pulp stumps, and allowed to set.
干预措施: Biodentine (Drug)
Group B : (Hyaluronic acid gel)
Hyaluronic acid gel will be compressed against the amputated pulp for 5 minutes. Then the pulp stumps will be dressed with a layer of zinc oxide-eugenol (ZOE) paste.
干预措施: Hyaluronic acid gel (Drug)
结局指标
主要结局
clinically successful pulpotomy
时间窗: 18 months
1. Pain symptom - free teeth on percussion as well as during mastication. 2. Absence of pathological tooth mobility. 3. Absence of swelling of pulpal origin. 4. . Absence of sinus tract.
radiographically successful pulpotomy
时间窗: 18 months
1. No internal or external root resorption. 2. No periapical or furcation radiolucency. 3. No widening of periodontal ligament space.
次要结局
未报告次要终点
研究者
Weaam ibrahiem eltantawy
assistant lecturer at pediatric department-Mansoura University
Mansoura University