Malocclusion Clinical Trial
Official title:
Does the Patient-specific Depth of the Lateral Nasal Wall Osteotomy Affect the Pterygomaxillary Separation During le Fort I Down-fracture?
Verified date | January 2024 |
Source | Bezmialem Vakif University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this clinical trial is to show the effect of patient specific lateral nasal wall osteotomy to the pterygomaxillary separation during Le Fort I down-fracture. Participants will be divided into two treatment groups. In study group, surgery planned according to the patients' indivudial anatomy and in the conventional group, surgery planned according to mean anatomical datas. Researchers will compare patient specific lateral nasal wall osteotomy to see if it affects the pterygomaxillary junction seperation during le fort I downfracture.
Status | Completed |
Enrollment | 43 |
Est. completion date | December 5, 2023 |
Est. primary completion date | October 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: The inclusion criteria - orthognathic surgery to treat malocclusion - sleep apnea - jaw asymmetry Exclusion Criteria: - cleft lip and palate - previous orthognathic surgery - rhinoplasty |
Country | Name | City | State |
---|---|---|---|
Turkey | Taha Pergel | Istanbul | Fatih |
Lead Sponsor | Collaborator |
---|---|
Bezmialem Vakif University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | lateral nasal wall separation | The primary outcome variable is lateral nasal wall separation:
Type 1 Separation from the osteotomy line Type 2 Separation 2-4 mm above the osteotomy line Type 3 Separation 4 mm or more above the osteotomy line |
1 year | |
Secondary | pterygomaxillary junction separation | The secondary outcome variable is pterygomaxillary separation
Type 1 Separation including the tuber maxilla Type 2 Separation from the pterygomaxillary junction Type 3 Separation including the pterygoid plates |
1 year |
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