Postoperative Pain Evaluation of Mineral Trioxide Aggregate and Propolis After Pulpotomy in Carious Primary Molars: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Evaluation of postoperative pain after pulpotomy by asking patient and/or parents (binary yes or no)
研究概览
简要总结
The study will be self-funded by investigator and carried out on patients from outpatient clinic in Pediatric Dentistry and Public Health Department- Faculty of Dentistry, Cairo University- Egypt. The procedures will be carried out by postgraduate student Rawda Nader Fathy who has B.D.S. (2011) -Alexandria University- Egypt. The procedures will be carried out on a Knight Midmark Biltmore dental unit (Midmark Corporation 1700 S. Patterson Blvd. Suite 400 Dayton, Ohio 45409, USA) in the post graduate clinic of Pediatric Dentistry and Public Health Department- Faculty of Dentistry, Cairo University- Egypt.
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
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cooperative patient
- •Healthy 5-8 years old patient with at least one carious primary molar tooth at each side of the patient's mouth.
- •Presence of at least two-thirds of the root length radiographically.
- •Restorable tooth.
- •No signs of hyperemia and hemostasis will be adequately achieved with moistened cotton pellet within 5 minutes after coronal pulp amputation.
排除标准
- •Teeth showing clinical and radiographic evidence of pulp degeneration such as history of spontaneous or nocturnal pain, tenderness to percussion or palpation, pathologic mobility, swelling or fistulous tract, periodontal ligament (PDL) space widening, internal root resorption, external root resorption, furcal radiolucency/inter- radicular bone destruction and/or periapical bone destruction.
- •Patients eliciting history of known allergy to pollens associated with propolis.
- •Parent or guardian refusal to participate.
研究组 & 干预措施
Propolis powder
- resin (50%),
- vegetable Balsam, wax
- essential aromatic oils (30%)
- salivary secretions (10%)
- pollen(5%)
- other substances (5%) including amino acids
,ethanol vitamin A, B complex, and E, minerals, steroids
- flavonoids. The most important pharmacologically active constituents in propolis are flavonoids, which are well-known compounds which have antioxidant, anti-bacterial, antifungal, antiviral, and anti-inflammatory properties.
- Other ingredients: carob powder (free flow agent). Contains no yeast, salt, sugar, starch, milk, preservatives or colors.
干预措施: Propolis (Drug)
Mineral Tri Oxide
- Consists of calcium oxide and silicon dioxide.When these raw materials are blended, they produce tricalcium silicate, dicalcium silicate, tricalcium aluminate, and tetracalcium aluminoferrite.
- A radiopacifier (bismuth oxide) is added to the cement for dental radiological diagnosis.
干预措施: Mineral Trioxide Aggregate (Drug)
结局指标
主要结局
Evaluation of postoperative pain after pulpotomy by asking patient and/or parents (binary yes or no)
时间窗: 9 months
Binary (yes or no)
次要结局
未报告次要终点
研究者
Rawda Nader Mahmoud
Principal Investigator
Cairo University