Ignite Creation Date:
2024-05-06 @ 12:55 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03884699
Status:
UNKNOWN
Last Update Posted:
2019-03-21
First Post:
2019-03-12
Brief Title:
Waferless One Stage Segmental Lefort I Maxillary Positioning in Transverse Deficiency
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Accuracy of Waferless One Stage Segmental Lefort I Maxillary Positioning in Transverse Deficiency Using CADCAM Patient Specific Titanium Implants Case Series Study
Status:
UNKNOWN
Status Verified Date:
2019-03
Last Known Status:
NOT_YET_RECRUITING
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:
In Maxillary transverse deficiency is waverless lefort I multiple pieces osteotomy using virtually planned patient specific titanium implants feasible and does it provide accuracy
This prospective case series study evaluating the postoperative outcomes and accuracy of preoperatively planned positional changes together with virtually designed drilling and fixation guides for the waferless positioning and fixation of the multiple pieces Le Fort I of the maxilla using CAD-CAM designed patient-specific implants
The purpose of this study is to develop and validate an orthognathic CADCAM patient specific implant together with template that can guide both the osteotomy and the repositioning of the maxilla during the correction of transverse maxillary deficiency
Thus the traditional model and the additional preparation for CADCAM surgical splints including scanning dental casts and recording and moving virtual dental casts were not required The preoperative and laboratory procedures were simplified and the intermediate splint technique was eliminated so the associated potential errors were avoided
This prospective case series study evaluating the postoperative outcomes and accuracy of preoperatively planned positional changes together with virtually designed drilling and fixation guides for the waferless positioning and fixation of the multiple pieces Le Fort I of the maxilla using CAD-CAM designed patient-specific implants
The purpose of this study is to develop and validate an orthognathic CADCAM patient specific implant together with template that can guide both the osteotomy and the repositioning of the maxilla during the correction of transverse maxillary deficiency
Thus the traditional model and the additional preparation for CADCAM surgical splints including scanning dental casts and recording and moving virtual dental casts were not required The preoperative and laboratory procedures were simplified and the intermediate splint technique was eliminated so the associated potential errors were avoided
Detailed Description:
The aim of this study is to evaluate the accuracy of planned waferless positioning of lefort I multiple piece osteotomy in maxillary deficient patients using CAD-CAM patient-specific implants together with virtually designed drilling and fixation guides
Interventions
1 Diagnostic procedures
All Patients will be selected according to inclusion and exclusion criteria Comprehensive clinical examination and understanding of patients chief complains and needs will be carried out Preoperative patient photographs Frontal Profile 45 smile and dental occlusion Alginate Impressions of upper lower jaws for acquiring diagnostic dental casts Cone Beam Computed Topography CBCT for the patients
2 Planning procedures
Computer-aided planning All planning will be done using specialized Mimics software Import CBCT into virtual planning software Segmentation highlighting and selection of the bony anatomy based on bone density Hounsfield Units
3D reconstruction virtual 3D model CT scanning of the dental stone casts Image fusion to combine the virtual casts onto the 3D bony model to obtain a composite artifact-free skull model
Virtual planning based on clinical evaluation and 3D cephalometric analysis Virtual osteotomies mimicking segmental Lefort I and a bilateral sagittal split osteotomy
Designing the virtual cutting guide Virtual movement into the desired positions of the segmented maxilla and mandible based on clinical evaluation 3D cephalometric analysis and the desired occlusion
Once the optimal position of the maxilla is achieved a patient specific implant will be virtually designed to fix the segmented maxilla in its new position
Fabrication of the cutting guide using additive manufacturing technique from polymer material
Fabrication of PSI from titanium alloy using additive manufacturing technique
3 Intra operative procedures The surgical procedures will be carried out by RT under the supervisor of AH in the Oral Maxillofacial operating floor on the 8th floor of the faculty of Oral Dental Medicine new buildingScrubbing and draping of the patient will be carried out in a standard fashion according to Anon 2006
Local anesthesia lidocaine 2 1100000 adrenaline will be injected intraorally along the incision lines for hemostasis
Access through a vestibular intraoral incision for maxilla Sagittal split incision for mandible will carried out Dissection and reflection to reach the bone
Bilateral Sagittal Split mandibular osteotomies will carried out The osteotomy guide 2 parts will into fit the left and right side the anterior maxillary walls separately during the operation for ease of use
Le Fort I Maxillary osteotomies will carried out using the osteotomy guide Complete mobilization of maxillary segments Reposition and fixation of the maxillary segments into the planned position will be done by the Patient Specific Implant PSI using the drilling site done by the osteotomy guide
Reposition and fixation of the mandibular segments using bicortical screws The incisions will be closed with continuous mattress absorbable sutures 4 Postoperative care Follow up Post-operative treatment will start immediately postoperative 4 hours Patients will start antibiotics 4 hours after the last intraoperative dose Amoxicillin Clavulanic acid 625 mg every 8 hours for 5 days Patients will start analgesics NSAIDs every 6 hours for 3 days Mouthwash Chlorhexidine 012 will be prescribed for 2 more weeks The patients will be scheduled for follow-up visits weekly for a month then on a monthly basis for 5 more months
At 1 to 3 weeks postoperatively CBCT using same parameters will be ordered to calculate the difference between surgical plan and actual outcome will be evaluated
Patient will be referred back to the orthodontist to receive his postsurgical orthodontics
Interventions
1 Diagnostic procedures
All Patients will be selected according to inclusion and exclusion criteria Comprehensive clinical examination and understanding of patients chief complains and needs will be carried out Preoperative patient photographs Frontal Profile 45 smile and dental occlusion Alginate Impressions of upper lower jaws for acquiring diagnostic dental casts Cone Beam Computed Topography CBCT for the patients
2 Planning procedures
Computer-aided planning All planning will be done using specialized Mimics software Import CBCT into virtual planning software Segmentation highlighting and selection of the bony anatomy based on bone density Hounsfield Units
3D reconstruction virtual 3D model CT scanning of the dental stone casts Image fusion to combine the virtual casts onto the 3D bony model to obtain a composite artifact-free skull model
Virtual planning based on clinical evaluation and 3D cephalometric analysis Virtual osteotomies mimicking segmental Lefort I and a bilateral sagittal split osteotomy
Designing the virtual cutting guide Virtual movement into the desired positions of the segmented maxilla and mandible based on clinical evaluation 3D cephalometric analysis and the desired occlusion
Once the optimal position of the maxilla is achieved a patient specific implant will be virtually designed to fix the segmented maxilla in its new position
Fabrication of the cutting guide using additive manufacturing technique from polymer material
Fabrication of PSI from titanium alloy using additive manufacturing technique
3 Intra operative procedures The surgical procedures will be carried out by RT under the supervisor of AH in the Oral Maxillofacial operating floor on the 8th floor of the faculty of Oral Dental Medicine new buildingScrubbing and draping of the patient will be carried out in a standard fashion according to Anon 2006
Local anesthesia lidocaine 2 1100000 adrenaline will be injected intraorally along the incision lines for hemostasis
Access through a vestibular intraoral incision for maxilla Sagittal split incision for mandible will carried out Dissection and reflection to reach the bone
Bilateral Sagittal Split mandibular osteotomies will carried out The osteotomy guide 2 parts will into fit the left and right side the anterior maxillary walls separately during the operation for ease of use
Le Fort I Maxillary osteotomies will carried out using the osteotomy guide Complete mobilization of maxillary segments Reposition and fixation of the maxillary segments into the planned position will be done by the Patient Specific Implant PSI using the drilling site done by the osteotomy guide
Reposition and fixation of the mandibular segments using bicortical screws The incisions will be closed with continuous mattress absorbable sutures 4 Postoperative care Follow up Post-operative treatment will start immediately postoperative 4 hours Patients will start antibiotics 4 hours after the last intraoperative dose Amoxicillin Clavulanic acid 625 mg every 8 hours for 5 days Patients will start analgesics NSAIDs every 6 hours for 3 days Mouthwash Chlorhexidine 012 will be prescribed for 2 more weeks The patients will be scheduled for follow-up visits weekly for a month then on a monthly basis for 5 more months
At 1 to 3 weeks postoperatively CBCT using same parameters will be ordered to calculate the difference between surgical plan and actual outcome will be evaluated
Patient will be referred back to the orthodontist to receive his postsurgical orthodontics
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