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临床试验/NCT04634123
NCT04634123已完成不适用

Evaluation Using of White Portland Cement and MTA in Pulpotomy Primary Anterior Teeth

Damascus University1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
Clinical evaluation of White Portland Cement pulpotomies 3 months after treatment

研究概览

简要总结

  • The aim of this study is to evaluate the effectiveness of White Portland cement and MTA in primary anterior teeth pulpotomy and follow up after 3 , 6 , 12 months ( Clinically and Radiographically) : Group A ( Control group ) : primary anterior teeth pulpotomized by White MTA . Group B : primary anterior teeth pulpotomized by White Portland Cement .

  • The aim of this study is to evaluate the effectiveness of White Portland cement and MTA in pulpotomy primary canines for serial extraction and extract them after 3 months for Histopathlogic study : Group A ( Control group ) : primary canines pulpotomized by White MTA . Group B : primary canines pulpotomized by White Portland Cement .

详细描述

  • Endodontic therapy for primary teeth faces several difficulties including morphology of root canals , physiological root absorption and failure to find ideal root-filling paste absorbs the same degree of root absorption .
  • Pulpotomy therapy is considered easy , fast and does not include the length of canal or periapical region .
  • The split mouth design will be adopted for the treated samples .
  • Clinical success criteria :
  1. Absence of spontaneous or stimulant pain
  2. Absence gingival redness , swelling or fistula
  3. Physiological tooth mobility and absence sensitivity to percussion
  • Radiographically success criteria :
  1. Absence periapical translucence
  2. Absence external or internal abnormal absorption

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
4 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age between 4 and 9 years.
  • Definitely positive or positive ratings of Frank scale.
  • Caries include maximum two surfaces
  • Pulp exposure during caries removal
  • Pulpal hemorrhage light red acceptable to hemostasis
  • Physiological root resorption no more than the apical third
  • Absence clinical and radiographic signs which indicate pulp necrosis

排除标准

  • Systematic or mental disorders.
  • Definitely negative or negative ratings of Frankel scale
  • Existence periapical translucence
  • Existence external or internal abnormal absorption
  • Existence swelling or fistula
  • Sensitivity to percussion
  • Existence of spontaneous or stimulant pain
  • Excessive movement

结局指标

主要结局

Clinical evaluation of White Portland Cement pulpotomies 3 months after treatment

时间窗: 3 months

Clinical evaluation of White Portland Cement pulpotomies was performed 3 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility

Clinical evaluation of White MTA pulpotomies 3 months after treatment

时间窗: 3 months

Clinical evaluation of White MTA pulpotomies was performed 3 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility

Radiographic evaluation of White Portland Cement pulpotomies 3 months after treatment

时间窗: 3 months

Radiographic evaluation of White Portland Cement pulpotomies was performed 3 months after treatment using periapical radiographs. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure

Radiographic evaluation of White Portland Cement pulpotomies 12 months after treatment

时间窗: 12 months

Radiographic evaluation of White Portland Cement pulpotomies was performed 12 months after treatment using periapical radiographs. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure

Clinical evaluation of White Portland Cement pulpotomies 12 months after treatment

时间窗: 12 months

Clinical evaluation of White Portland Cement pulpotomies was performed 12 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility

Radiographic evaluation of White Portland Cement pulpotomies 6 months after treatment

时间窗: 6 months

Radiographic evaluation of White Portland Cement pulpotomies was performed 6 months after treatment using periapical radiographs. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure

Radiographic evaluation of White MTA pulpotomies 6 months after treatment

时间窗: 6 months

Radiographic evaluation of White MTAt pulpotomies was performed 6 months after treatment using periapical radiographs. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure

Histopathlogic evaluation of White MTA 3 months after treatment

时间窗: 3 months

Histopathlogical evaluation of White MTA pulpotomies was performed 3 months after treatment using the preset histopathlogical criteria. The pulpotomy procedure was decided a histopathlogical success if the tooth fulfilled the following criteria: (1) Normal soft tissue, (2) Formulation dentin bridge, (3) Normal bleeding from pulp tissue, (4) No fibrosis, and (5) No pulp calcification

Clinical evaluation of White Portland Cement pulpotomies 6 months after treatment

时间窗: 6 months

Clinical evaluation of White Portland Cement pulpotomies was performed 6 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility

Radiographic evaluation of White MTA pulpotomies 12 months after treatment

时间窗: 12 months

Radiographic evaluation of White MTAt pulpotomies was performed 12 months after treatment using periapical radiographs. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure

Clinical evaluation of White MTA pulpotomies 12 months after treatment

时间窗: 12 months

Clinical evaluation of White MTA pulpotomies was performed 12 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility

Radiographic evaluation of White MTA pulpotomies 3 months after treatment

时间窗: 3 months

Radiographic evaluation of White MTAt pulpotomies was performed 3 months after treatment using periapical radiographs. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure

Clinical evaluation of White MTA pulpotomies 6 months after treatment

时间窗: 6 months

Clinical evaluation of White MTA pulpotomies was performed 6 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility

Histopathlogic evaluation of White Portland Cement 3 months after treatment

时间窗: 3 months

Histopathlogical evaluation of White Portland Cement pulpotomies was performed 3 months after treatment using the preset histopathlogical criteria. The pulpotomy procedure was decided a histopathlogical success if the tooth fulfilled the following criteria: (1) Normal soft tissue, (2) Formulation dentin bridge, (3) Normal bleeding from pulp tissue, (4) No fibrosis, and (5) No pulp calcification

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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