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临床试验/NCT03804450
NCT03804450已完成2 期

Magnetic Resonance Imaging Assessment of Pulp Regeneration Following Regenerative Endodontic Procedures in Mature Teeth

Alexandria University1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2017年7月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
18
试验地点
1
主要终点
MRI assessment of pulp-like tissue regeneration

研究概览

简要总结

The present study was conducted to test whether pulp-like tissue can be regenerated in mature teeth with closed apex? And whether the size of the apical diameter affects the success of REPs? And whether Magnetic resonance imaging (MRI) can be used to quantitatively assess the vitality of the regenerated pulp-like tissue.

详细描述

Regenerative endodontic procedures via blood clot were done on 18 mature anterior necrotic teeth with periapical lesions. The teeth were randomly assigned into two groups according to the size of the apical diameter of the rotary files used for instrumentation.

In the test group, rotary instrumentation was done using Pro-taper Next till size X3, while in the control group, instrumentation was done till size X5.

Calcium hydroxide was used as an intracanal medication for 1-2 weeks. Calcium hydroxide was then washed away using 1.5%NaOCl, followed by induction of blood using pre-curved K-fi;e #25 2mm past the radiographic apex. Biodentine was then used as a cervical plug over the blood clot followed by resin-modified glass ionomer cement and composite resin as coronal restoration.

MRI was used to assess the vitality of the regenerated pulp-like tissue, where the signal intensity of the regenerated pulp-like tissue was measured after 3,6 and 12 months follow up and compared to the normal contralateral teeth. In addition, sensibility tests using cold test and electric pulp testing were used to assess vitality of regenerated pulp-like tissue after 3,6,9 and 12 months. Cone beam computed tomography (CBCT) was also used to assess the healing of the periapical lesion after 12 months.

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 (Participant)

入排标准

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

入选标准

  • 未提供

排除标准

  • Presence of systemic diseases.
  • Presence of stainless steel wires o brackets
  • Vital immature teeth with open apex

研究组 & 干预措施

Control group

Experimental

The root canals were instrumented using Pro-taper next rotary files till size X5. REPs via blood clot using calcium hydroxide were then applied.

干预措施: Regenerative endodontic procedures (REPs) (Procedure)

Test group

Experimental

The root canals were instrumented using Pro-taper next rotary files till size X3. REPs via blood clot using calcium hydroxide were then applied

干预措施: Regenerative endodontic procedures (REPs) (Procedure)

结局指标

主要结局

MRI assessment of pulp-like tissue regeneration

时间窗: 12 months

Signal intensity of the regenerated pulp-like tissue was quantitatively measured in both test and control groups after 3,6 and 12 months follow up and compared to the contralateral normal teeth.

次要结局

  • Positive pulpal response(12 months)
  • Healing of the periapical lesion(12 months)

研究者

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

Noha Mohamed El Kateb

Assistant lecturer, Faculty of dentistry

Alexandria University

研究点 (1)

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