Comparative evaluation of pulpotomy using Mineral trioxide aggregate (MTA), Diode Laser and Er, Cr: YSGG Laser in primary molar teeth– A Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1. Clinical success of pulpotomy on the basis of:
研究概览
简要总结
This study is a randomized, single-blinded, single-centre trial comparing the clinical and radiographic success of Pulpotomy using Mineral Trioxide Aggregate (MTA), Diode Laser and Er,Cr:YSGG Laser in primary molar teeth– A Randomized Controlled Trial in children in the age group of 5-8 years in the Department of Pediatric and Preventive Dentistry, MAIDS. The primary outcome will depict the clinical and radiographic success of Pulpotomy and the secondary outcome will compare the 3 types of Pulpotomy treatment. All patients will be evaluated at baseline, 3, 6 and 9 months. The need for this study arises from the of comprehensive data on their respective clinical performances in vivo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Children between the age group of 5 to 8 years.
- •Primary molars in which coronal portion of pulp is involved (indicated for pulpotomy)
- •Parents/Children willing to give informed consent/informed assent respectively.
- •Apparently healthy Children without systemic or metabolic disorders.
排除标准
- •Children with irreversible pulpitis, chronic pulpalgia, and abnormal sensitivity of tooth to heat and cold.
- •Tenderness to percussion or palpation because of pulpal disease.
- •Inter radicular or periapical bone destruction as seen on radiographs.
- •Children with special health care needs.
结局指标
主要结局
1. Clinical success of pulpotomy on the basis of:
时间窗: baseline (T0), 3 month (T1), 6 months (T2) and 9 | months (T3)
• Normal appearance of gingiva.
时间窗: baseline (T0), 3 month (T1), 6 months (T2) and 9 | months (T3)
• Absence of clinical signs and symptoms of pulpal inflammation such as spontaneous pain, tenderness, swelling, fistula, abscess formation.
时间窗: baseline (T0), 3 month (T1), 6 months (T2) and 9 | months (T3)
• Absence of mobility in the tooth.
时间窗: baseline (T0), 3 month (T1), 6 months (T2) and 9 | months (T3)
2. Radiographic success of pulpotomy on the basis of:
时间窗: baseline (T0), 3 month (T1), 6 months (T2) and 9 | months (T3)
• Absence of any periapical or inter radicular radiolucencies.
时间窗: baseline (T0), 3 month (T1), 6 months (T2) and 9 | months (T3)
• The integrity of lamina dura.
时间窗: baseline (T0), 3 month (T1), 6 months (T2) and 9 | months (T3)
• Absence of pathologic root resorption.
时间窗: baseline (T0), 3 month (T1), 6 months (T2) and 9 | months (T3)
次要结局
- Er,Cr:YSGG laser and Diode Laser show comparable(clinical and radiographic sucsess as Mineral Trioxide Aggregate (MTA) in Pulpotomy in primary molars.)
研究者
Dr Vishal
Maulana Azad Institute of Dental Sciences