Dentofacial Deformities Clinical Trial
Official title:
Reverse Engineering Utilizing the 3D Photogrammetry Technique Versus Commercial Scanners for Accurate Repositioning of the Maxilla After Le-fort I Osteotomy for Correction of the Dentofacial Deformity (Randomized Controlled Clinical Trial).
Current advances in the three-dimensional virtual surgical planning (3D-VSP) of the orthognathic surgery have brought newer insights, enormous benefits and have become an indispensable aid for diagnosis, treatment planning and outcome assessment especially in the management of dentofacial deformities. The extent to which the planned surgical outcome could be achieved is dependent on the surgeon's ability to accurately transfer the planned movements to the real surgical field. Accurate repositioning of the maxilla after Le-fort I osteotomy is of utmost importance for an esthetic and functional purposes. The goal of this interventional study is to compare the 3D photogrammetry technique versus the commercial scanners for accurate repositioning of maxillary segment after le-fort I osteotomy using the reverse engineering technology. The main question it aims to answer; Is the utilization of the 3D Photogrammetry technique affect the accuracy of maxillary segment repositioning after le-fort I osteotomy compared with the commercial scanners?
Status | Recruiting |
Enrollment | 24 |
Est. completion date | August 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Age range of 18-60 years. - Patients requiring one-piece Le-Fort I osteotomy as part of their orthognathic surgery for the correction of dentofacial deformity. - Patients should be free from any significant medical condition that could affect or hinder normal healing and predictable outcomes. - Patients with no signs or symptoms of temporomandibular joint disorders. - Patients who will be committed to the follow up period and agree to sign the informed consent. Exclusion Criteria: - Patients requiring segmental Le-Fort I osteotomy. - Patients with previous history of orthognathic surgery. - Patients with cleft lip and palate. - Patients with skeletal deformities owing to trauma or tumor resection. - Patients with any intra-bony lesions or infections. - Patients with temporomandibular joint disorders. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Dentistry, Cairo University | Giza |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
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Pietzka S, Mascha F, Winter K, Kammerer PW, Sakkas A, Schramm A, Wilde F. Clinical Accuracy of 3D-Planned Maxillary Positioning Using CAD/CAM-Generated Splints in Combination With Temporary Mandibular Fixation in Bimaxillary Orthognathic Surgery. Craniomaxillofac Trauma Reconstr. 2020 Dec;13(4):290-299. doi: 10.1177/1943387520949348. Epub 2020 Aug 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of maxillary segment repositioning | The actual postoperative 3D maxillary segment position will be compared with the preoperative virtual maxillary positioning by:
A) Linear and angular measurements: Some specific reproducible points and planes will be identified on the 3D virtual model, and then on the post-surgery model. The distance from points to planes will be calculated on each model and the difference between these distances is to be registered as the error of accuracy. B) Color-coded map: Different colors show the distance between the surfaces, with green color usually showing the lack of distance, meaning zero error of accuracy. This method of assessing changes in 3D surfaces involves measuring the point-to-point distance of one mesh (VSP - 3D model reference) to the second mesh (Postoperative - 3D model test) and generating a color distance map. |
Outcome will be assessed with immediate postoperative Computed Tomography at one week. |
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