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临床试验/NCT06176378
NCT06176378已完成不适用

A Clinical and Radiographic Evaluation of Low-Level Diode Laser Full Pulpotomy in Vital Permanent Teeth

Al-Azhar University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年10月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Assessment of success or failure

研究概览

简要总结

In this study, patients with symptoms of irreversible pulpitis in mature permanent molars were treated with two pulpotomies techniques after random allocation in either 2 groups: Diode laser pulpotomy and traditional pulpotomy using bioactive materials (retro mineral trioxide aggregate ) with each group.The null hypothesis of the study was there would be no difference in success rate between Diode laser and traditional methods of adult pulpotomy .

详细描述

In this study, 40 patients with symptoms of irreversible pulpitis in mature permanent 1st and 2nd molars were treated with two pulpotomy techniques after random allocation in either 2 groups: traditional pulpotomy and low-level diode laser pulpotomy. The pulp in each group was capped with Retro MTA . In the traditional pulpotomy group, the coronal pulp was removed by the traditional method while in the low-level diode laser pulpotomy group, the radicular pulp was biostimulated using low-level diode laser beam with parameters (970nm, power .5Watt, duty cycle 50%, and frequency 5H) 10 sec for each pulp stump in non-contact mode. After that, the capping material was prepared as manufacturer's instructions and applied over the pulp stamp, the final restoration was then placed in both groups. Patients were followed up after 6, 12, and 18 months to evaluate success and failure.

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
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Assessment of success or failure

时间窗: (T1): 1 week postoperative, (T2): after 6 months, (T3): after 12 months, and (T4) after 18 months.

Assessment of success or failure was done using the technique described by Galeni et al Treatment was considered successful if the patient's final restoration was intact and the patient demonstrated no clinical symptoms (pain (spontaneous or on chewing), swelling, or sinus tract), and had a periapical index score of 1. • Treatment was considered uncertain if the patient's final restoration was intact, and the patient demonstrated no clinical symptoms (pain (spontaneous or on chewing), swelling, or sinus tract), and a PAI score of 2. • Treatment was considered a failure in the following situations: 1\. Any case in which the final restoration was not intact. Irrelevant clinical and radiographic symptoms. 2\. Any case in which the final restoration was intact and the patient demonstrated clinical symptoms. Irrelevant of PAI score. 3\. Any case in which the final restoration was intact and the patient had a PAI score of 3 or above. Irrelevant of clinical symptoms.

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

Ehab Ali Elsayed

principal investigator/Assistant Lecturer

Al-Azhar University

研究点 (2)

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