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临床试验/NCT06020911
NCT06020911已完成4 期

Clinical and Radiographic Evaluation of Indirect Pulp Capping Using Biodentine and Theracal Light-cured in Primary Molars

Tanta University1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2023年1月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
17
试验地点
1
主要终点
Radiodenisty in Hounsfield units

研究概览

简要总结

this study is aimed to conduct tomographic evaluation of reparative dentin bridges formed after indirect pulp capping with Biodentine and Theracal light cured. The null hypothesis of the study is that there will be no difference in the quantity and quality of reparative dentin formation between the tested materials used for the indirect pulp capping

详细描述

Many materials have been used in indirect pulp capping for primary dentition. An ideal pulp capping material is to be successful when it is biocompatible, radiopaque, maintain good seal, protect the pulp against bacterial invasion in both long and short run, release sustained amounts of calcium ions, act as reservoir for calcium hydroxide and stimulate reparative dentin formation through inducing the pulp cells to form odontoblasts.

Theracal light cured is a light-cured resin modified calcium silicate (RMCS) used as an indirect pulp capping material. It releases more calcium ions than Mineral trioxide aggregate or dycal inducing reparative dentin and dentin bridge formation.Theracal light cured showed better sealing ability and less microleakage than Mineral trioxide aggregate and Biodentine

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
None

入排标准

年龄范围
4 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Each child has bilateral vital cavitated carious lesions in primary molars.
  • Positive vital pulp testing for both hot and cold response; is determined by ethyl chloride in cold pulp testing and heated gutta percha in hot pulp testing. Pain caused by these tests should not persist after the stimulus is removed.
  • Patient and parent cooperation.
  • Accessible isolation for the operated tooth with rubber dam.
  • primary molars with cavitated carious lesion on either occlusal or proximal surface that extend into the dentin .
  • Availability of remaining dentin thickness over the pulp.
  • Normal lamina dura and periodontal ligaments. 8 Absence of external and internal root resorption.

排除标准

  • Spontaneous pain, or persistent swelling or fistula.
  • Pain with percussion, presence of abscess and pathological mobility.
  • Uncooperative patient.
  • Progression of caries lesion to pulp and pulp exposure.
  • Presence of periapical lesion as abscess, cyst or granuloma.
  • Unhealthy bony tissues.

研究组 & 干预措施

Biodentine

Active Comparator

17 primary second molars of 17 children will be capped with Biodentine.

干预措施: Biodentine (Drug)

Theracal light cured

Active Comparator

17 primary second molars of 17 children will be capped with Theracal light cured

干预措施: Theracal light cured (Drug)

结局指标

主要结局

Radiodenisty in Hounsfield units

时间窗: UP to 9 months postoperatively

Cone-beam computed tomography(CBCT) scan will be used after placing the capping material once at the start immediately postoperative after restoration and at the end of follow up period after 9 months to evaluate the Radiodenisty in Hounsfield units

pulp vitality

时间窗: UP to 9 months postoperatively

The teeth in each group will be examined clinically after restoration and at the end of the follow up period using vitality tests. Treatment is considered to be successful when pulp remains vital with no signs of pain, no evidence of tooth mobility, normal tooth color, normal gingival health and presence of the restoration intact

Thickness of dentin in mm

时间窗: UP to 9 months postoperatively

Cone-beam computed tomography(CBCT) scan will be used after placing the capping material once at the start immediately postoperative after restoration and at the end of follow up period after 9 months to evaluate the Thickness of dentin in mm

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa Abd Elhameed Abd Elghany

Principle investigator Alaa Abd Elhameed Abd Elghany

Tanta University

研究点 (1)

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