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临床试验/NCT03770871
NCT03770871已完成4 期

Evaluation of Resin Modified Glass Ionomer Liner (Vitrebond™) Versus Calcium Hydroxide as Indirect Pulp Treatment Material Used in Deep Carious Lesions in Primary Molars: A Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2016年8月最近更新:
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
88
试验地点
1
主要终点
Number of cases reporting postoperative pain

研究概览

简要总结

This study was conducted to evaluate the clinical and the radiographic success of Dycal and Vitrebond as indirect pulp treatment materials in primary molars.

详细描述

Evaluation of calcium hydroxide and resin modified glass ionomer liner clinically and radiographically as indirect pulp treatment materials in deep caries in primary molars.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Double blinded

入排标准

年龄范围
4 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

IPT using Dycal (TM )

Active Comparator

Indirect pulp treatment; IPT using Dycal (TM ); (2 paste system) by partial caries removal

干预措施: Indirect pulp treatment using Dycal (TM) (Drug)

IPT using Dycal (TM )

Active Comparator

Indirect pulp treatment; IPT using Dycal (TM ); (2 paste system) by partial caries removal

干预措施: Indirect pulp treatment using Vitrebond (TM ) (Drug)

IPT using Vitrebond (TM )

Experimental

Indirect pulp treatment; IPT using Vitrebond (TM );(powder and liquid) by partial caries removal

干预措施: Indirect pulp treatment using Dycal (TM) (Drug)

IPT using Vitrebond (TM )

Experimental

Indirect pulp treatment; IPT using Vitrebond (TM );(powder and liquid) by partial caries removal

干预措施: Indirect pulp treatment using Vitrebond (TM ) (Drug)

结局指标

主要结局

Number of cases reporting postoperative pain

时间窗: 12 months

Presence of postoperative pain following dental treatment through patient questionnaire as a sign of clinical failure

Number of cases reporting swelling

时间窗: 12 months

Presence of postoperative swelling following dental treatment through visual examination using hand mirror as a sign of clinical failure

Number of cases reporting sinus

时间窗: 12 months

Presence of sinus following dental treatment through visual examination using hand mirror as a sign of clinical failure

Number of cases reporting fistula

时间窗: 12 months

Presence of fistula following dental treatment through visual examination using hand mirror as a sign of clinical failure

Number of cases reporting tooth mobility

时间窗: 12 months

Presence of abnormal tooth mobility following dental treatment through tactile examination using two hand mirrors as a sign of clinical failure

次要结局

  • Number of cases reporting widening of periodontal membrane space(12 months)
  • Number of cases reporting external root resorption(12 months)
  • Number of cases reporting internal root resorption(12 months)
  • Number of cases reporting furcation involvement(12 months)
  • Number of cases reporting periapical radiolucency(12 months)

研究者

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

Mohamed Farouk Rashed

Researcher assisstant

Cairo University

研究点 (1)

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