Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403930
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2024-05-02
Brief Title:
Accuracy of Maxillary Obturator Bulb in Maxillectomy Defects
Sponsor:
Badr University
Organization:
Badr University
Study Overview
Official Title:
Bland-Altman Analysis of Maxillary Obturator Bulb Accuracy in Class III Brown Classification Maxillectomy Defects
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 patients 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
Rapid prototype production techniques present a viable alternative to conventional methods for constructing facial prostheses By utilizing computer-aided imaging techniques such as computed tomography CT magnetic resonance imaging MRI and laser surface scanners highly accurate extraoral facial prostheses can be crafted using CAD-CAM and RP technologies These advanced techniques ensure excellent contours and tissue adaptation resulting in prostheses that seamlessly integrate with the patients facial features and enhance their overall appearance
While conventional gypsum models are typically used for prosthetic rehabilitation of intraoral deformities like maxillectomy defects the integration of 3D CAD and RP technologies can significantly enhance outcomes A crucial aspect of creating a functional and aesthetically pleasing prosthesis lies in obtaining an accurate impression of the defect site However this process is often complicated by various factors such as the properties of the impression material the size and nature of the defect the presence of undercuts and the condition of remaining teeth all of which influence the accuracy of the impression Additionally challenges like pain tears and deformations during impression removal as well as bleeding and mucosal adhesion further complicate the process Limitations in mouth opening may also hinder the optimal insertion of the impression materials further emphasizing the need for advanced techniques and materials
Despite the advantages associated with surgical reconstruction procedures they may not always be feasible due to the patients 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
Rapid prototype production techniques present a viable alternative to conventional methods for constructing facial prostheses By utilizing computer-aided imaging techniques such as computed tomography CT magnetic resonance imaging MRI and laser surface scanners highly accurate extraoral facial prostheses can be crafted using CAD-CAM and RP technologies These advanced techniques ensure excellent contours and tissue adaptation resulting in prostheses that seamlessly integrate with the patients facial features and enhance their overall appearance
While conventional gypsum models are typically used for prosthetic rehabilitation of intraoral deformities like maxillectomy defects the integration of 3D CAD and RP technologies can significantly enhance outcomes A crucial aspect of creating a functional and aesthetically pleasing prosthesis lies in obtaining an accurate impression of the defect site However this process is often complicated by various factors such as the properties of the impression material the size and nature of the defect the presence of undercuts and the condition of remaining teeth all of which influence the accuracy of the impression Additionally challenges like pain tears and deformations during impression removal as well as bleeding and mucosal adhesion further complicate the process Limitations in mouth opening may also hinder the optimal insertion of the impression materials further emphasizing the need for advanced techniques and materials
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None