Clinical and Radiographic Evaluation of Pulpotomy in Primary Molars Treated With Premixed Bio-ceramic MTA Versus Formocresol Among a Group of Egyptian Children: A Pilot Study.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 40
- 主要终点
- Soft-tissue pathology
研究概览
简要总结
examine the results of pulpotomy in primary molars using premixed bioceramic MTA versus Formocresol. Clinical and radiographic success rates were used as outcomes.
详细描述
Primary outcome:
Soft-tissue pathology
- Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally.
- Sinus tract or fistula will be assessed through visual examination by the operator
Secondary outcomes:
- Pain to the percussion will be assessed by gentle tapping on the tooth with the end of a dental mirror
- mobility will be assessed through the back of two mirrors
- radiographic assessments:- for any radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically fit and cooperative children.
- •Pediatric patients aged 4-6 years.
- •A deep carious lesion in vital primary molars.
- •Absence of clinical signs and symptoms of pulpal exposure.
- •Absence of radiographic signs and symptoms of people degeneration.
- •Positive parental informed consent.
排除标准
- •Uncooperative children.
- •Medically compromised children.
- •Presence of clinical signs and symptoms of pulpal exposure.
- •Presence of radiographic signs and symptoms of pulp degeneration.
- •Physiologic root resorption more than one-third.
研究组 & 干预措施
control group
the group that have caries in primary molars and treat them with formocresol
干预措施: Formocresol (Drug)
experimental group
the group that have caries in primary molars and treat them with premixed bioceramic MTA
干预措施: Premixed bioceramic MTA (Drug)
结局指标
主要结局
Soft-tissue pathology
时间窗: at 1 year
Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally. -Sinus tract or fistula will be assessed through visual examination by the operator. Binary (present or absent)
次要结局
- mobility(at 1 year)
- radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).(at 1 year)
- • Pain to the percussion(at 1 year)
研究者
Sarah Abdelbar Mahmoud
principal investigator
Cairo University