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临床试验/NCT06403930
NCT06403930已完成不适用

Bland-Altman Analysis of Maxillary Obturator Bulb Accuracy in Class III Brown Classification Maxillectomy Defects

Badr University2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2024年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
19
试验地点
2
主要终点
Root mean square

研究概览

简要总结

Treatment of tumors in the paranasal region often requires maxillectomy procedures. While surgical reconstruction is preferred, prosthetic reconstruction using obturators becomes necessary when surgery is not feasible. Obturators separate oral and nasal cavities, restoring functions like chewing, speech, and facial aesthetics, while alleviating psychological distress. The emergence of rapid prototyping (RP) technologies since 1995 has revolutionized prosthetic construction. RP techniques like stereolithography and 3D printing enable layer-by-layer production of accurate 3D models from computer designs. Combined with imaging like CT and MRI, RP allows creation of highly precise extraoral facial prostheses. For intraoral defects, integrating 3D CAD and RP can enhance prosthetic outcomes compared to conventional gypsum models, although obtaining accurate impressions remains challenging due to factors like defect size, undercuts, and mucosal issues.

详细描述

The treatment of tumors in the paranasal region often necessitates either palatal maxillectomy or radical maxillectomy procedures, which involve the surgical removal of a portion or the entire maxillary bone. While these surgical interventions are aimed at treating the underlying condition, they can result in significant functional and aesthetic deficits for the patient. In such cases, surgical and prosthetic interventions offer avenues to address these post-maxillectomy challenges, ensuring both functional and aesthetic outcomes.

Despite the advantages associated with surgical reconstruction procedures, they may not always be feasible due to the patient's overall health condition or the extent of the defect. In these situations, prosthetic reconstruction becomes an imperative solution. Temporary or permanent obturators serve as effective prosthetic devices in this context, with the primary aim of separating the oral and sinonasal cavities. This separation is crucial in preventing issues such as hypernasal speech, which occurs when air escapes through the nasal cavity during speech, and fluid leakage into the nasal cavity, which can lead to discomfort and potential health complications.

Beyond their functional role in separating the cavities, obturators play a pivotal role in restoring essential functions like chewing, swallowing, and speech. They provide support to the lips and cheeks, aiding in the restoration of facial contour and aesthetics. Moreover, these prosthetic devices contribute significantly to alleviating the social and psychological distress experienced by patients, as they help to restore a sense of normalcy and self-confidence.

The emergence of rapid prototype production technology, also known as rapid prototyping (RP) or laser-layered manufacturing, has revolutionized the creation of three-dimensional solid models. This technique, which has seen global advancement since 1995, enables the layer-by-layer production of physical models directly from computer-aided designs in a single step. Unlike traditional computer-assisted design (CAD)-computer-aided manufacturing (CAM) systems that involve material removal, rapid prototype techniques employ technologies like lasers and numerical control to build models layer by layer, facilitating the creation of intricate internal details and smooth surfaces, even in complex structures.

Various rapid prototype techniques, including stereolithography (SLA), laminated object manufacturing, selective laser sintering, fused deposition modeling, and three-dimensional printing, offer diverse options for model production. These techniques utilize different materials and layering methods but can be combined to achieve desired outcomes, making them highly versatile and adaptable to specific requirements.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • The study enrolled participants of all genders who had defects or abnormalities involving both hard and soft palate regions.
  • Participants were included if their surgical site was fully healed and they had partial tooth loss or missing teeth in the maxilla defect area.
  • Only cooperative patients capable of following instructions were selected.

排除标准

  • Individuals with temporomandibular disorders.
  • uncontrolled diabetes.
  • bleeding disorders.
  • ongoing anticoagulant therapy.
  • Patients with flabby tissues.
  • sharp mandibular residual ridges.
  • heavy smoking habits.
  • neuromuscular disorders.
  • severe psychiatric conditions were also not eligible for the study.
  • The study did not include children, with only adult participants considered.

结局指标

主要结局

Root mean square

时间窗: 10 days

Serial 3D dental model superimposition allows for a detailed, risk-free evaluation of morphological changes in a patient's mouth over time. In this study, the accuracy and precision of five different palatal areas used for superimposing maxillary 3D digital dental casts were evaluated.

次要结局

未报告次要终点

研究者

发起方
Badr University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shady El Naggar

Clinical Assistant Professor

Badr University

研究点 (2)

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