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临床试验/NCT01420718
NCT01420718已完成2 期

Partial Pulpotomy on Caries Free Human Teeth Using iRootBP and White ProRoot MTA: a Randomized Controlled Trial

Islamic Azad University, Tehran1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2011年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
dentinal bridge formation

研究概览

简要总结

The purpose of this study is to compare the human pulp response to partial pulpotomy using White ProRoot MTA or iRoot BP in the terms of dentinal bridge formation and inflammation.

详细描述

This will be a randomized single blind clinical trial. Setting and conduct: Twenty caries free premolar teeth from fifteen patients assigned for orthodontic extraction will be included. Participants including major eligibility criteria: Their parents need to sign an informed form, Patients shouldn't have any systematic complication, The teeth should be free of any symptom, caries and decalcification and should reveal a normal response to pulp sensitivity tests, No mobility or swelling in the surrounding soft tissues, sensitivity on palpation or percussion should be present. Intervention: A class one cavity will be prepared and the depth will be increased until the pulp exposure occurs. One millimeter of the coronal pulp will be removed. Then the exposure site will be covered using two pulpotomy agents: White ProRoot MTA as control group and iRoot BP. After six weeks (42 days) the teeth will be extracted after radiographic and clinical examination to find any sign of swelling, abscess or sinus tract. Main outcome measures (variables): The teeth will be sectioned and examined to compare the presence of dentinal bridge, its thickness and feature in the terms of tunnel defect formation. The underlying pulp will be assessed and graded according to the degree of inflammation as follows: grade 0 no inflammation, grade 1 mild inflammation, grade 2 moderate inflammations, grade 3 severe inflammation, grade 4 abscess formation or necrosis. Our criteria are based on ISO 7405.

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
Single (Outcomes Assessor)

入排标准

年龄范围
10 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients who are assigned to extract two premolar teeth in one jaw for orthodontic treatment plan.
  • Their parents need to read and sign a fully informed form.
  • They shouldn't have any systematic complication or take any medicine during the period of study.
  • The teeth need to be free of any symptom, caries and decalcification
  • They should give a normal response to pulp sensitivity tests (cold test) compared to the control tooth on the same quadrant.
  • The teeth need to be free of mobility or swelling in the surrounding soft tissues and any sensitivity on palpation or percussion.
  • On radiographic examination no apical lucency or PDL widening should be detected.

排除标准

  • tooth crack
  • tooth filling
  • any caries
  • hypocalcification
  • The teeth showing apical lucency
  • PDL widening on radiography
  • sensitivity to cold, heat or bite
  • The responses beyond the normal limits to pulp vitality testing
  • Any medicine consumption

研究组 & 干预措施

Mineral Trioxide Aggregate

Active Comparator

partial pulpotomy using White ProRoot MTA. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material.

干预措施: MTA (Drug)

iRoot BP

Experimental

Partial pulpotomy using iRoot BP. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material. Bioaggregate is the first nano particle, water based root end filling material. This product includes calcium silicate, calcium hydroxide, hydroxy apatite and Tantalum oxide. Compared to MTA,this material lacks Bismuth oxide and calcium aluminate. iRoot BP is the injectable for of Bioaggregate (Injectable Root Bioaggregate Paste).

干预措施: iRoot BP (Drug)

结局指标

主要结局

dentinal bridge formation

时间窗: six weeks after intervention

appearance of the dentinal bridge compared to normal dentin will be assessed under microscope

次要结局

  • inflammatory status of the pulp(six weeks after intervention)

研究者

发起方
Islamic Azad University, Tehran
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahta Fazlyab

post graduate student of Endodontic department, Dental Branch

Islamic Azad University, Tehran

研究点 (1)

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