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临床试验/CTRI/2024/07/070134
CTRI/2024/07/070134尚未招募4 期

Evaluation of Strut retained versus Screw retained patient specific implants in rehabilitation of post COVID mucormycosis maxillectomy Defects. A randomized controlled trial

NAVINKUMAR SHANKURWAR1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年8月9日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Quality of life

研究概览

简要总结

This randomized controlled trial compares the effectiveness of two types of patient-specific implants in rehabilitating maxillectomy defects resulting from post-COVID mucormycosis. The study evaluates the outcomes of using both strut-retained and screw-retained implants in this context. By assessing factors such as quality of life, ease of surgery , ease of prosthesis fabrication, aesthetic outcomes, and patient satisfaction, the research aims to provide insights into the optimal approach for restoring maxillectomy defects in individuals affected by post-COVID mucormycosis.

Tailored patient-specific implants (PSIs) represent a precise solution for facial reconstruction, with two main types available: PSI with struts (PSI 1) and PSI with screw-retained implants embedded within (PSI 2). Computer surgical planning is crucial for this process, enabling surgeons to strategize and adjust defects and flaps with unobstructed 3D visualization. Integration of 3D-printed cutting guides, based on computer-generated plans, simplifies complex closing osteotomies, effectively translating virtual designs into real-world surgery. Compared to traditional implants, PSIs offer heightened accuracy, superior site adaptation, and reduced operating time. This transformative technology signifies a significant advancement in maxillofacial surgery, providing a more precise, efficient, and patient-tailored approach to reconstruction.

This study is planned in department of oral and maxillofacial surgery Government dental college and hospital Nagpur To evaluate and compare the effectiveness of Strut-Retained and Screw-Retained Patient-Specific Implants in rehabilitation of post covid mucormycosis maxillectomy defect.

Primary research question What is the comparative effectiveness of Strut-Retained and Screw-Retained Patient-Specific Implants in the rehabilitation of Post-COVID Mucormycosis maxillectomy defects ?

Null hypothesis : There is no difference in strut retained and screw retained patient specific implants in rehabilitating post covid mucormycosis maxillectomy defect

Alternative hypothesis : There is difference in strut retained and screw retained patient specific implants in rehabilitating post covid mucormycosis maxillectomy defect.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patients with post covid mucormycosis maxillectomy defect.
  • Good general health status.
  • Patient with good bone support and soft tissue in the area intended for implant placement.
  • Patient with good oral hygiene and motivation.

排除标准

  • Poor oral hygiene and motivation.
  • Patients with systemic immunocompromised conditions.
  • Acute or chronic infection/inflammation in the area intended for implant placement.
  • Patients with habit of smoking, kharra chewing, tobacco chewing.
  • Para-functional habits.
  • Radiotherapy to the head and neck region
  • Patient on bisphosphonate therapy.

结局指标

主要结局

Quality of life

时间窗: post operatively 1 week 1 month 3 month 6 month

Ease of prosthesis fabrication

时间窗: post operatively 1 week 1 month 3 month 6 month

次要结局

  • Ease of surgery(Intra operative time)

研究者

发起方
NAVINKUMAR SHANKURWAR
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Navinkumar Shankurwar

Government Dental College and Hospital, Nagpur.

研究点 (1)

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