Mineral Trioxide Aggregate/Ferric Sulfate Pulpotomy for Vital Primary Incisors: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcome at 12 Months Post-procedure.
研究概览
简要总结
To compare radiographic and clinical outcomes and survival of mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy and root canal therapy (RCT) in carious vital primary maxillary incisors.
详细描述
Dental caries is the most common chronic disease in children. Caries of the primary maxillary incisors is common in young children; often necessitating either extraction or pulp therapy. The premature loss of primary maxillary incisors can adversely affect a child's dental occlusion, ability to properly size food boluses for swallowing, speech articulation, facial esthetics and psychosocial development. Pulp treatment of cariously exposed vital primary incisors may prevent premature tooth loss as well as eliminate pain. Currently, there is a paucity of outcome investigations with regard to pulp therapy in primary incisors.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children with one or more carious primary maxillary incisors where removal of dental caries will likely to produce a vital pulp exposure
- •reside in the GTA at time of inclusion
- •English-speaking
排除标准
- •history of spontaneous or lingering stimulated pain, swelling, fistula or sinus tract, tenderness to percussion and pathological mobility
- •incisors with preoperative radiographic evidence of periapical or periradicular radiolucency, a widened periodontal ligament space, physiological resorption, incomplete root formation, internal or external root resorption, pulp canal obliteration or pulp calcifications
- •non-restorable tooth
结局指标
主要结局
Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcome at 12 Months Post-procedure.
时间窗: 12 months after the procedure
Two disinterested pediatric dentists classified each treated incisor into one of three outcomes: N=incisor without pathologic change; Po=pathologic change present, follow-up recommended; and Px=pathologic change present, extract. Incisors rated N or Po were considered an acceptable radiographic outcome while incisors rated as Px were considered unacceptable.
Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcomes 18 Months Post-procedure.
时间窗: 18 months after the procedure
Two disinterested pediatric dentists classified each treated incisor into one of three outcomes: N=incisor without pathologic change; Po=pathologic change present, follow-up recommended; and Px=pathologic change present, extract. Incisors rated N or Po were considered an acceptable radiographic outcome while incisors rated as Px were considered unacceptable.
次要结局
- Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 18 Months Post-procedure.(18 months after the procedure)
- MTA/FS Pulpotomy and RCT Treated Incisor Survival(12 and 18 months)
- Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 12 Months Post-procedure.(12 months after the procedure)
研究者
Peter Judd
Dentist-in-Chief
The Hospital for Sick Children