Comparative Evaluation of Premixed Bioceramic Putty Versus MTA as Apical Plugs in Nonvital Immature Anterior Teeth: A Clinical Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- the clinical success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA)
研究概览
简要总结
Following the randomization procedure, children will be divided into 2 groups (25 immature anterior permanent incisors in each group): Group I will be treated with MTA as apical plug while group II will be treated with Premixed Bioceramic Putty as apical plug. After working length determination, instrumentation, and irrigation of the root canals, apical plug will be done. in MTA Group, MTA will be placed into the apical 4 mm of root canals, then a moist cotton pellet will be placed and the access cavity will be restored with glass-ionomer-based restoration. Next day, glass-ionomer-based restoration and the cotton pellet will be removed, then the coronal restoration will be completed with GIC, composite. In the Premixed Bioceramic Putty group, Well-Root™ PT will be placed into the apical 4 mm of the canals. After 12 min, the coronal and middle third of the root canal will be filled with gutta-percha. The coronal restoration will be completed with GIC, composite.
children will be recalled for clinical and radiographical follow-up after 6 and12 months after treatment.
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
- 8 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •nonvital immature permanent teeth as a consequence of trauma or dental caries
- •nonvital permanent teeth with radiographic evidence of immature root end development
- •clinically restorable teeth
排除标准
- •immature nonvital permanent teeth presenting with signs/symptoms of internal/external resorption, moderate to severe mobility, periodontal bone loss
- •Immature nonvital permanent teeth associated with developmental abnormalities.
- •Patients with a history of systemically debilitating diseases
- •unrestorable remaining crown structure
研究组 & 干预措施
Premixed Bioceramic Putty group
After the endodontic procedure, Premixed Bioceramic Putty (Well-Root™ PT) will be placed into the apical 4mm of the canals. After 12 min, the coronal and middle third of the root canal will be filled with gutta-percha. The coronal restoration will be completed with GIC, composite.
干预措施: Premixed Bioceramic Putty (Procedure)
MTA group
After the endodontic procedure, MTA will be placed into the apical 4 mm of the root canals. then a moist cotton pellet will be placed and the access cavity will be restored with GIC. Next day, GIC and the cotton pellet will be removed the coronal and middle third of the root canal will be filled with gutta-percha. The coronal restoration will be completed with GIC, composite.
干预措施: Mineral trioxide aggregate (Procedure)
结局指标
主要结局
the clinical success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA)
时间窗: up to 12 months
The apexification procedure will be recorded as a clinical success if the tooth fulfils the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility.
the radiographic success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA)
时间窗: at 6 and12 months follow up
The apexification procedure will be recorded to be radiographically successful if it demonstrates the following criteria: (1) reduction of apical lesion size (2) Normal periodontal ligament space (2) No furcation pathosis, and (3) No external resorption. The apexification procedure will be radiographically unsuccessful if the apical lesion size increases. The apexification procedure will be doubtful if the apical lesion size doesn't change
次要结局
- Change in the periapical index (PAI)(at 6 and12 months follow up)
研究者
Shaimaa Shaban Mohamed El-desouky
Lecturer of Pediatric dentistry
Tanta University