Dentofacial Deformities Clinical Trial
Official title:
Stability of Two Different Designs of Patient Specific Osteosynthesis "One Piece VS Two Piece" For The Fixation of LeFort 1 Osteotomy in Maxillary Orthognathic Surgery A Randomized Clinical Trial
A comparison of the stability of two different designs of patient specific fixation devices for the performance of splintless computer guided le fort 1 osteotomy in orthognathic surgery workflow for the correction of a variety of dentofacial deformities
Status | Recruiting |
Enrollment | 34 |
Est. completion date | December 10, 2022 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Adult patients with dentofacial deformity: skeletal class 2, class 3, vertical maxillary excess, Facial asymmetry. - Patient seeking definitive surgical correction and refusing orthodontic camouflage. - Maxillary impaction, advancement and rotations. - Highly motivated patients. - Good oral hygiene. - Patients willing for the surgical procedure and follow-up, with an informed consent Exclusion Criteria: - Medically compromised patients - Uncooperative patients - Poor oral hygiene - Periodontal diseases - Patients with no desire for surgical correction - Patients with any diseases that compromise bone or soft tissue healing Patients with local pathology that interfere with the bone healing |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of oral and dental medicine | Cairo | Manial |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Stability of the new maxillary position | Primary outcome will be the positional stability of the repositioned maxilla which will be measured via CT scan by superimposing the postoperative maxillary segment obtained from a 4 months postoperative CT | 4 months | |
Secondary | Intra-operative time | stop watch is used toc calculate the intra-operative time | Intra-operative | |
Secondary | Patient satisfaction using Visual Analogue Scale | Patient satisfaction will be gauged using VAS 3 months postoperatively | 3 months |
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