Partial Versus Complete Pulpotomy Using Three Different Materials in Primary Molars: a Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- post operative pain
研究概览
简要总结
The purposes of the study to compare partial pulpotomy versus complete pulpotomy in primary molars using three different materials (Formocresol, MTA, Theracal LC) . After 6, 9, 12 and 15 months follow up each case will be evaluated radiographically and clinically. the radiographic criteria to be evaluated are (radiolucency, resorption, widening in periodontal ligament space, Crypt involvement) and clinical criteria are ( pain, tenderness, fistula, abnormal mobility) upon these criteria some recommendations will be made on success and failure rate of each material and each technique.
详细描述
In children, deep carious lesions represent the most common disease of primary teeth; 42% of children aged 2 to 11 have dental carious lesions in their primary teeth, with an average of 1.6 decayed teeth per child. The most important objective of pediatric dentistry treatment is the preservation of functional primary teeth until natural exfoliation. In the era of conservative dentistry we are now focusing on repair rather than replacement.
Challenges regarding the best treatment modality in primary molars with deep carious lesions that are free of signs or symptoms have continued over the years. Based on a recent systematic review and a new American Academy of Pediatric Dentistry (AAPD) Guideline for vital pulp therapy in primary teeth, indirect pulp therapy (IPT), direct pulp cap (DPC), and pulpotomy are all viable options for treating the pulp in primary teeth with deep carious lesions.
Partial pulpotomy (PP) was originally a means of preserving the remaining coronal and radicular pulp tissues in permanent teeth after a traumatic pulp exposure. In 1982, Cvek introduced this technique for permanent traumatized teeth with complicated crown fracture, which involved removing two mm of pulp and then dressing the non-inflamed pulp with calcium hydroxide. However, according to the new AAPD best practices recommendation, PP is also indicated in young permanent teeth with a carious pulp exposure in which pulpal bleeding can be controlled within several minutes.
Calcium Hydroxide PP of primary molar teeth with deep carious lesions is used in studies conducted by Schroder and Trairatvorakul. Schroder. showed that the clinical-radiographic success rate of primary molar teeth one year after PP was 83 percent; they concluded that PP has the same favorable outcome as cervical formocresol pulpotomy (FP).
If the pulp is diagnosed as normal or as having reversible pulpitis, a new regenerative material is recommended as the dressing material. In comparison with complete pulpotomy (i.e., removal of the entire pulp chamber), PP has several advantages; it causes limited injury to the pulp and limited loss of tooth substances, and this is important for pulpal healing and easier restoration.
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 (Participant)
盲法说明
the children and their parents are blinded from the material that will be used and the technique
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No history of spontaneous or nocturnal pain.
- •History of transient pain of sensitivity resulting from various stimuli: hot, cold and sweets.
- •Patient who had a bilateral deep carious lesion at second primary molars.
- •absence of tenderness to percussion
- •absence of physiologic or pathologic tooth mobility
- •Radiographic evidence of no internal or external resorption.
- •There is not an intraradicular or periapical bone loss or widening of the periodontal ligament space.
排除标准
- •history of spontaneous or nocturnal pain.
- •Patient who had a unilateral deep carious lesion.
- •presence of tenderness to percussion
- •presence of physiologic or pathologic tooth mobility
- •Radiographic evidence of internal or external resorption.
- •There is an intraradicular or periapical bone loss or widening of the periodontal ligament space.
研究组 & 干预措施
formocresol pulpotomy
gold standard arm which pulpotomy will be done with formocresol
干预措施: Formocresol (Drug)
formocresol pulpotomy
gold standard arm which pulpotomy will be done with formocresol
干预措施: pulpotomy (Procedure)
formocresol partial pulpotomy
partial pulpotomy will be done with formocresol
干预措施: Formocresol (Drug)
formocresol partial pulpotomy
partial pulpotomy will be done with formocresol
干预措施: partial pulpotomy (Procedure)
MTA pulpotomy
in this group complete pulpotomy will be done with MTA
干预措施: MTA (Drug)
MTA pulpotomy
in this group complete pulpotomy will be done with MTA
干预措施: pulpotomy (Procedure)
MTA partial pulpotomy
in this study group partial pulpotomy will be done with MTA
干预措施: MTA (Drug)
MTA partial pulpotomy
in this study group partial pulpotomy will be done with MTA
干预措施: partial pulpotomy (Procedure)
pulpotomy with Theracal LC
in this study group complete pulpotomy will be done with Theracal LC
干预措施: TheraCal (Drug)
pulpotomy with Theracal LC
in this study group complete pulpotomy will be done with Theracal LC
干预措施: pulpotomy (Procedure)
partial pulpotomy with Theracal LC
in this study group partial pulpotomy technique will be done with Theracal LC
干预措施: TheraCal (Drug)
partial pulpotomy with Theracal LC
in this study group partial pulpotomy technique will be done with Theracal LC
干预措施: partial pulpotomy (Procedure)
结局指标
主要结局
post operative pain
时间窗: 15 months
numerical/visual analogue scale 0 no pain 10 worst possible pain
次要结局
- radiolucency(15 months)
- tenderness(15 months)
- root resorption(15 months)
- tooth mobility(15 months)
- widening in periodontal ligament space(15 months)
- fistula(15 months)
- permanent tooth crypt involvement(15 months)