NCT03545139Unknown1 期
Clinical and Radiographic Evaluation of Neo MTA Versus Conventional White MTA in Revascularization of Non-Vital Immature Permanent Anterior Teeth: A Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Discoloration/ Staining potential
研究概览
简要总结
- To evaluate and compare the degree of tooth discoloration in tooth crowns induced by Neo MTA versus white MTA over time.
- Evaluation of the effectiveness of Neo MTA as coronal plug in revascularization of immature teeth with necrotic pulp.
详细描述
The new formulation of MTA (NeoMTA) does not contain bismuth oxide, will be used in revascularization of nonvital immature permanent anterior teeth.
to evaluate the effectiveness of Neo MTA as coronal plug and compare the degree of tooth discoloration in tooth crowns induced by Neo MTA versus white MTA over time.
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)
入排标准
- 年龄范围
- 7 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of patients: 7-15years old.
- •Free from any systemic diseases that may affect the normal healing process.
- •Tooth with immature root apex.
- •Traumatically or cariously exposed non vital permanent anterior tooth.
- •Pulp space not needed for post and core for final restoration.
- •Compliant patient/parent
排除标准
- •Patients having allergy to medicaments and antibiotics necessary to complete procedure.
- •Tooth with vital pulp or complete root formation.
- •Teeth with internal or external root resorption.
- •Un-cooperative patients.
- •Luxative injuries.
- •Teeth with a root fracture
- •Alveolar fracture
- •Subjects with chronic systemic illness.
- •Subjects with poor oral hygiene.
- •Compromised remaining tooth structure as teeth with extensive loss of coronal tissue will require restoration with a post that will occupy the space required for blood clot formation.
研究组 & 干预措施
NeoMTA (intervention group)
Experimental
Revascularization with NeoMTA as coronal plug.
干预措施: NeoMTA nusmile (Biological)
White MTA (Control group)
Active Comparator
Revascularization with Conventional white mineral trioxide aggregate (White MTA) as coronal plug.
干预措施: White MTA (Biological)
结局指标
主要结局
Discoloration/ Staining potential
时间窗: 9 month
Using spectrophotometer by operator
次要结局
- Pain on biting(9 month)
- Pain on percussion(9 month)
- Sinus or fistula, recurrent swelling(9 month)
- Root lengthening(9 month)
研究者
Hala Ahmed Tawfik
Researcher assistant at orthodontic and pediatric dentistry department National Research centre
Cairo University
研究点 (1)
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