Evaluation of Strut retained versus Screw retained patient specific implants in rehabilitation of post COVID mucormycosis maxillectomy Defects. A randomized controlled trial
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
Navinkumar Shankurwar
Government Dental College and Hospital, Nagpur.
