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临床试验/NCT06553222
NCT06553222尚未招募3 期

Minimally Invasive Non-surgical Therapy With or Without Injectable Bone Putty in Treating Intra-bony Periodontal Defects (Randomized Controlled Clinical Trial)

Al-Azhar University0 个研究点目标入组 30 人开始时间: 2024年11月4日最近更新:
适应症

试验速览

阶段
3 期
状态
尚未招募
入组人数
30
主要终点
Primary outcome

研究概览

简要总结

• All periodontitis patients with infra bony pockets to be included in this study will diagnosed as having stage III periodontitis with probing pocket depth (PPD) ≥ 6 mm, and clinical attachment loss (CAL) ≥ 5mm will be treated by minimally invasive non-surgical therapy or by injectable bone putty

详细描述

The present study will be designed as a randomized controlled clinical and radiographic. The study will be carried out on stage III grade (B) periodontitis patients with intra-bony defects. Those patients will be selected from the outpatient clinics of the Department of Oral Medicine and Periodontology, Faculty of Dental Medicine, Al-Azhar University, Assiut branch.

The study has bee approved by the ethical committee, Faculty of Dental medicine, Al-Azhar University, Assiut branch.

  1. All patients will be fully informed about the study's nature and the possible risks of the study procedures; they sign the consent form before the work.

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)

盲法说明

the outcome assessor will assess the bone gain (Radiographic) and Clinical attachment level (clinical) in both groups. the assessor is blinded whether a graft was loaded at the time of surgery

入排标准

年龄范围
35 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • All periodontitis patients to be included in this study should be diagnosed as having stage III periodontitis with probing pocket depth (PPD) ≥ 6 mm, and clinical attachment loss (CAL) ≥ 5mm.
  • 2- or 3-wall intra-bony interproximal defect with depth ≥3 mm, a width of ≥3 mm at its most coronal part and 45-55-degree angulation will be selected in order to reduce defect variability
  • All patients will be free from any systemic diseases according to the American Dental Academy general guidelines for referring dental patients to specialists and other care settings.

排除标准

  • Any patients with any systemic condition that contraindicate any surgical intervention

结局指标

主要结局

Primary outcome

时间窗: measured at 6 and 12 months postoperative

measurement (mm) in alveolar bone gain

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

Hagar Ahmed Saad

Investigator

Al-Azhar University

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