Clinical and Radiographic Evaluation of Triple Antibiotic Paste and Calcium Hydroxide With Iodoform as Intra-canal Medications in Regenerative Treatment of Necrotic Primary Teeth Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- number of patients treated in the 3 groups and have a clinical success according to the checklist absence of pain, pain on percussion, mobility, clinical abscess or fistula
研究概览
简要总结
Necrotic primary molars in preschool children will be treated with the regeneration concept to provide a healthy biological environment within the root canal system and regression in clinical signs and symptoms which are the primary outcomes of regeneration treatment.
详细描述
A convenient sample of preschool children have a necrotic primary second molar randomly allocated to one of the 3 study groups which are: group A (control) treated by the conventional treatment ( pulpectomy followed by stainless steel crown SSC), group B: treated by regeneration using triple antibiotic paste followed by SSC), group 3:(treated by regeneration using calcium hydroxide with iodoform(metapex) followed by SSC.
the 3 groups were evaluated at baseline, 6 months and 12 months for clinical and radiographic success.
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, Outcomes Assessor)
盲法说明
participant and outcomes assessor will be blind to which group they belong or assess respectively
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
- •A child with one or more necrotic primary teeth
- •Presence of abscess/fistula
- •Sensitivity to percussion
- •Presence of maximum grade 2 mobility ( Not more than 1 mm)
- •Increases of the dental lamina dura
- •cooperative patients
排除标准
- •Medically compromised children
- •Patient allergic to any of the used materials
- •Presence of pathologic root resorption (internal-external) or more than 1/3 of the apical root.
- •Presence of vitality in the canals
- •Presence of grade 3 mobility
- •Non-restorable teeth
研究组 & 干预措施
necrotic primary molar treated with pulpectomy followed by SSC
control group treated by pulpectomy under rubber dam isolation access cavity will be prepared by a round bur then filling and irrigation will be performed and the tooth will be restored with a temporary filling. After one week all signs and symptoms will be assessed in case of absence of signs and symptoms the tooth will be restored with zin oxide and eugenol and SSC
干预措施: pulp regeneration for necrotic primary teeth (Other)
necrotic primary molar treated with regeneration using triple
under rubber dam isolation access cavity will be prepared by a round bur then minimal filling and irrigation will be performed then triple antibiotic paste will be inserted into the canals and the tooth will be restored by a glass ionomer (GI) as a temporary filling. After2-4 weeks all signs and symptoms will be assessed in case of absence of signs and symptoms an endodontic file will be used to induce bleeding from the periapical area after hemostasis mineral trioxide aggregate will be applied followed by SSC
干预措施: pulp regeneration for necrotic primary teeth (Other)
necrotic primary molar treated with regeneration using metape
under rubber dam isolation access cavity will be prepared by a round bur then minimal filling and irrigation will be performed then calcium hydroxide with iodoform (metapex) will be inserted into the canals and the tooth will be restored by a glass ionomer (GI) as a temporary filling. After 2-4 weeks all signs and symptoms will be assessed in case of absence of signs and symptoms an endodontic file will be used to induce bleeding from the periapical area after hemostasis mineral trioxide aggregate will be applied followed by SSC
干预措施: pulp regeneration for necrotic primary teeth (Other)
结局指标
主要结局
number of patients treated in the 3 groups and have a clinical success according to the checklist absence of pain, pain on percussion, mobility, clinical abscess or fistula
时间窗: 12 months
the blind outcome assessor will evaluate the clinical success at 6 and 12 years
number of patients treated in the 3 groups and have a radio graphic success according to the checklist absence of radiolucency, internal or external root resorption
时间窗: 12 months
the blind outcome assessor will evaluate the radio graphic success at 6 and 12 years
次要结局
未报告次要终点
研究者
dina darwish
assistant lecture
Ain Shams University