Clinical and Radiographic Evaluation of Turmeric, Thymus Vulgaris, Nigella Sativa and Aloe Vera as Pulpotomy Medicaments in Primary Teeth" A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Clinical signs and symptoms of pulp reaction
研究概览
简要总结
when caries reaches the pulp of the tooth, it has to be removed and replaced with a material. In this study im examining the clinical and radiographic signs and symptoms after using different natural materials in pulpotomized molars and compared to the formocresol.
详细描述
Patients who have irreversible pulpitis and need pulpotomy will be selected randomly from the out patient clinic. they will be assigned randomly to different study and control groups. pulpotomy will be performed in the second primary molar and 1 of the five materials will be put in the pulp chamber (aloe vera, nigella sativa, thymus vulgaris, turmeric and formocresol). It will be covered with a restoration and a stainless steel crown. Patients follow up will be done after 1,3,6 and 12 months to assess clinical and radiographic signs and symptoms.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged from 4 to 7 years old
- •Patients who are medically free
- •Patients who have a restorable vital deep carious primary molar which is indicated for pulpotomy.
- •No clinical signs or symptoms as pain on percussion, tooth mobility, presence of sinus or fistula, history of swelling.
- •No radiographic signs of any periapical pathosis or signs of internal or external root resorption.
排除标准
- •Patients who have any medical condition.
- •Teeth that are badly broken down, that cannot be restored.
- •Presence of uncontrolled bleeding.
- •Clinical evidence of non-vitality such as presence of an abscess or a sinus or premature mobility.
- •Radiographic evidence of bone resorption, internal or external root resorption and periapical or interradicular radiolucency.
结局指标
主要结局
Clinical signs and symptoms of pulp reaction
时间窗: 1 to 6 months
Evaluated using Zurn and Seale criteria. (pain, infection, gingival health, tooth mobility) where 1 indicates asymptomatic and 4 indicates severe discomfort
Radiographic signs of pulp reaction
时间窗: 1 to 6 months
Evaluated using Zurn and Seale criteria. (radiolucency, bone resorption, internal or external resorption) where 1 indicates no radiographic changes while 4 indicates the presence of pathologic changes
次要结局
未报告次要终点
研究者
Rana sharaf
principle investigator
Ain Shams University