Clinical and Radiographic Evaluation in Pulpotomy of Primary Molars Using Novel Fast-setting Calcium Silicate Cement (Protooth) Versus Mineral Trioxide Aggregate (MTA): A Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Clinical evaluation including postoperative pain , pain on percussion or palpation will be measured using VAS
研究概览
简要总结
The aim of the study is to evaluate the clinical and radiographic success in pulpotomy using novel fast-setting calcium silicate cement (Protooth) versus MTA in exposed primary molars.
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)
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
- •Complete physical and mental health, with no confounding history of systemic disease and/or use of special local or systemic drugs
- •No allergic reactions recorded in patient history
- •Having primary molar teeth in one jaw, having deep caries and vital pulp.
- •No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of vestibule
- •Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test
- •Radiographic criteria:
- •No sign of radiolucency in periapical or furcation area
- •No widening of PDL space or loss of lamina dura continuity
- •No evidence of internal/external pathologic root resorption
排除标准
- •Lack of informed consent by the child patient's parent
- •Lack of informed consent by the child patient's parent
- •Unable to attend follow-up visits.
- •Refusal of participation.
研究组 & 干预措施
Novel fast setting calcium silicate ( Protooth)
In the form of powder and liquid to be mixed together to form paste.
干预措施: Novel fast-setting calcium silicate cement (Protooth) (Drug)
MTA
In form of powder to be mixed with saline to form paste.
干预措施: Novel fast-setting calcium silicate cement (Protooth) (Drug)
结局指标
主要结局
Clinical evaluation including postoperative pain , pain on percussion or palpation will be measured using VAS
时间窗: 12 months
Post-operative pain following pulpotomy treatment will be measured. A pain chart using visual analogue scale (VAS) will be used to record the patients' pain levels. The VAS (0-10 scale) consists of a line anchored by two extremes "No pain" and "the worst pain". Patients will be asked to choose the mark that represented their level of pain from 0 to 10. Pain level will be assigned as follow: 0, "no pain" 1-3, "mild pain" 4-6, "moderate pain" 7-10, "severe pain" Using the VAS chart, the patient will choose and record the most appropriate pain rating according to the pain intensity endured.
次要结局
- Radiographic evaluation following the Pulpotomy treatment will be measured(12 months)
研究者
Nashwa Ossama Ahmed Elshaer
principle investigator
Cairo University