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临床试验/NCT06807320
NCT06807320已完成4 期

CLINICAL and RADIOGRAPHIC COMPARISON of MINERAL TRIOXIDE AGGREGATE and CALCIUM HYDROXIDE AS INDIRECT PULP CAPPING AGENTS in PRIMARY MOLARS: a RANDOMIZED CLINICAL TRIAL

Shaheed Zulfiqar Ali Bhutto Medical University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年1月1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
40
试验地点
1
主要终点
Dentine bridge thickness (DBT)

研究概览

简要总结

The study is designed as randomized clinical trial performed at the Department of Pediatric Dentistry , Pakistan Institute of Medical Sciences (PIMS) , Islamabad on primary molars requiring indirect pulp treatment in patients aged 5 to 9 years. Two groups , I and II of 40 teeth each will be selected according to inclusion criteria . In Group I , indirect pulp capping will be done with Calcium hydroxide while in Group II , it will be done with MTA . Both the groups will be evaluated clinically and radiographically at 0, 3 and 6 months . Results were compiled and analyzed using standard statistical techniques.

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
Single (Participant)

入排标准

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

入选标准

  • •Clinical Criteria :
  • •Primary molars with deep carious lesions
  • •No H/O spontaneous pain
  • •No associated swelling
  • •No tenderness to percussion
  • •Absence of pathological mobility
  • •No sinus tract
  • •Restorable
  • •Radiographic Criteria :
  • •No periapical radiolucency
  • •No loss of lamina dura
  • •No physiological root resorption
  • •Teeth with radiographic evidence of more than 0.25mm remaining dentin thickness
  • •No furcal radiolucency

排除标准

  • •Non restorable teeth
  • •Teeth with pathological mobility
  • •Teeth with extensive external/internal root resorption.
  • •Teeth with pulp canal calcifications
  • •Subjects inability to tolerate any of the dental products being used
  • •Systemic disease or severe medical complications ; Lack of compliance

研究组 & 干预措施

Group II patients, MTA

Experimental

MTA powder ( ProRoot; Dentsply ⁄ Tulsa Dental, Tulsa, OK,USA) was added to sterile water. The mixture was left to achieve a sandy consistency for about thirty seconds. Then, the material was applied to the cavity using a ball condenser.

干预措施: MTA pulp dressing material (Drug)

Group I patients, Calcium hydroxide

Active Comparator

For Group I patients, Calcium hydroxide (Dycal_ Ivory,Dentsply Caulk, Dentsply, L.D. Caulk, Milford, DE,USA ) was used. The catalyst and paste were mixed as per the manufacturer's recommendations.

干预措施: Calcium Hydroxide (Ca(OH)2) (Drug)

结局指标

主要结局

Dentine bridge thickness (DBT)

时间窗: 3 and 6 months follow up appointment in all successful cases.

Dentine bridge thickness (DBT) was measured at the 3 and 6 months follow up appointment in all successful cases.

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

RANA AHMAD

ASSISTANT PROFESSOR

Shaheed Zulfiqar Ali Bhutto Medical University

研究点 (1)

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