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临床试验/NCT03284697
NCT03284697已完成不适用

Success of Direct Pulp Capping With Mineral Trioxide Aggregate and Calcium Hydroxide In Cariously Exposed Teeth: A Randomized Clinical Study.

Postgraduate Institute of Dental Sciences Rohtak0 个研究点目标入组 64 人开始时间: 2016年10月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
64
主要终点
Evaluate and compare the clinical and radiographic success with MTA and calcium hydroxide as direct pulp capping materials.

研究概览

简要总结

Aim of the study was to evaluate and compare clinical and radiographic success with MTA and calcium hydroxide as direct pulp capping materials in cariously exposed mandibular molars.

Study was conducted in Post Graduate Institute of Dental Sciences, Rohtak in department of Conservative Dentistry & Endodontics. Mature permanent mandibular molars with reversible pulpitis exhibiting occlusal pulp exposure from primary dental caries were included in the study. After excavation of caries and obtaining pulpal hemostasis, patients were randomly allocated into two groups- MTA and Calcium Hydroxide. Pulp was capped with respective allocated material and then tooth in both groups were restored according to standard protocol.

详细描述

AIM AND OBJECTIVES The present study aims to

  1. Evaluate the success of direct pulp capping in mandibular molar teeth.
  2. Evaluate and compare the clinical and radiographic success with MTA and calcium hydroxide as direct pulp capping materials.
  3. To assess the pain intensity before and after the direct pulp capping with visual analog scale (VAS).

MATERIALS AND METHODS Study subjects were recruited from the patients visiting the Department of conservative dentistry and endodontics, PGIDS, Rohtak.

METHODOLOGY Prior to treatment, a thorough clinical and radiological examination was carried out.

A thorough history will be taken from each patient. Prior informed consent was obtained either from the patient or guardians after explaining the procedure, risks and benefits.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
15 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patient willing to participate in the study.
  • Age group- 15-40 years.
  • Mature permanent mandibular molars with reversible pulpitis.
  • Teeth exhibiting occlusal pulp exposure from primary dental caries.

排除标准

  • Primary teeth.
  • Teeth with irreversible pulpitis (spontaneous pain) or pulp necrosis, chronic periodontitis, cracked tooth, internal or external resorption, calcified canals, associated with sinus tract, and furcation or apical radiolucency.
  • Immuno-compromised, diabetic, pregnant and hypertensive patients.
  • Positive history of antibiotic and analgesic use within past one month of the treatment.
  • Failure to obtain authorization from patients.

研究组 & 干预措施

DPC with Ca(OH)2

Active Comparator

Direct pulp capping with Ca(OH)2.

干预措施: Direct Pulp Capping with Ca(OH)2 (Procedure)

DPC with MTA

Active Comparator

Direct pulp capping with MTA

干预措施: Direct Pulp Capping With MTA (Procedure)

结局指标

主要结局

Evaluate and compare the clinical and radiographic success with MTA and calcium hydroxide as direct pulp capping materials.

时间窗: Baseline to 1 year

CRITERIA FOR SUCCESSFUL OUTCOME * A positive vitality test. * No pain on percussion. * No widening of periodontal ligament on periapical radiograph. * No clinical or radiographic signs and/or symptoms of irreversible pulpitis and pulp necrosis. CRITERIA FOR FAILURE * No response to pulp vitality test. * Teeth exhibiting clinical or radiographic signs and/or symptoms of irreversible pulpitis and pulp necrosis.

次要结局

  • To assess the pain intensity before and after the direct pulp capping with visual analog scale (VAS).(Baseline to 7 days)

研究者

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

Sanjay Tewari

Principal

Postgraduate Institute of Dental Sciences Rohtak

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