Clinical and Radiographic Assessment of Partial and Complete Pulpotomy in Primary Molars Using MTA : A Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- swelling
研究概览
简要总结
that's comparison between partial and complete pulpotomy techniques in primary teeth
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All participants will be randomly assigned to know which one of the right or left side will be allocated randomly in either the control or the intervention group.
Sequence Generation Eligible consented participants will be randomly assigned to know which one of the participants will be control or intervention group according to a sequence generated on a Microsoft Excel sheet where the intervention (I) and the control (C) are simply randomized. The table of sequence generation will be kept with the co-supervisor.
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically free children who will be able and cooperative in all steps of the study.
- •Asymptomatic primary molars with a deep carious lesion.
- •Vital pulp due to dental caries with no clinical sign of pulpal degeneration (spontaneous pain, fistula, mobility) prior to treatment.
- •3 - Preliminary radiographs indicating absence of pathologic internal or external root resorption, or any evidence of inter-radicular bone destruction.
- •4 - Absence of pre-operative pain or they will only have a short-term pain. 5 - No tenderness to percussion. 6-Age ranging 4-6 years.
排除标准
- •1- Excessive bleeding during pulp amputation. 2 - Non vital teeth. 3 -History of spontaneous or prolonged pain. 4 - Swelling, tenderness, to percussion or palpation, or pathologic mobility. 5 - pre-operative radiographic pathology such as resorption (internal, external); periradicular or furcation radiolucency, or a widened periodontal ligament space.
- •6 - Parent or guardians who refuse participating in the study
研究组 & 干预措施
group A
placed with light pressure over the pulpal stumps (if hemorrhage control will not be achieve, tooth will be exclude ) 9.The pellet will be remove, and the pulp chamber filled with MTA. 10.The tooth will prepare and restore with a stainless steel crown cemented with glass ionomer cement
干预措施: MTA material (Combination Product)
group B
- Pre-operative radiograph showing all roots and their apices.
- Local anesthesia will be administered and a rubber dam will take place ,that ensure good isolation of the treated teeth.
- Removal of caries
- Pulp chambers will access using a no.330 bur in a high-speed hand piece with water coolant.
- Removal of any remains of coronal pulp tissue with sharp sterile excavator or large bur in slow hand piece
- Pulp amputation will perform using a spoon excavator.
- Hemorrhage control will obtain within 5 minutes using sterile cotton pellets placed with light pressure over the pulpal stumps (if hemorrhage control will not be achieve, tooth will be exclude )
- The pellet will be remove, and the pulp chamber will be filled with MTA.
- The tooth will prepare and restore with a stainless steel crown cemented with glass ionomer cement.
The periapical radiographic will be taken at this baseline visit .
干预措施: MTA material (Combination Product)
结局指标
主要结局
swelling
时间窗: 6 months
clinical examination
postoperative pain
时间窗: 6 months
analog scale
mobility
时间窗: 6 months
clinical examination
postoperative pain
时间窗: 1 week
analog scale
postoperative pain
时间窗: 1 month
analog scale
postoperative pain
时间窗: 3 months
analog scale
swelling
时间窗: 1 week
clinical examination
swelling
时间窗: 1 month
clinical examination
swelling
时间窗: 3 months
clinical examination
mobility
时间窗: 1 week
clinical examination
mobility
时间窗: 1 month
clinical examination
mobility
时间窗: 3 months
clinical examination
次要结局
- root resorption(6 months)
- Bone resorption(6 months)
- root resorption(1 week)
- root resorption(1 month)
- root resorption(3 months)
- Bone resorption(1 week)
- Bone resorption(1 month)
- Bone resorption(3 months)
研究者
fatma zainalabdieen abdelraouf
Master degree student
Cairo University