Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
NCT ID:
NCT02660216
Eligibility Criteria:
Inclusion Criteria:
* Patients of all ages
* Patients of all genders
* A Le Fort I osteotomy is planned, as part of a bimaxillary orthognathic procedure
* The surgery is planned with 3D Virtual Treatment Planning (Maxilim v. 2.3.0.3.0.)
* The planning is transferred with 3D CAD/CAM tooth-borne splint and vertical internal bony reference landmarks
* The maxilla is repositioned first during the surgery (maxilla first sequence)
Exclusion Criteria:
* Patients not eligible according to abovementioned criteria
* Simultaneous extraction of impacted teeth 18 and/or 28
* Previous maxillary orthognathic surgery
* Previous Surgical Assisted Rapid Palatal Expansion (SARPE)
* Syndromic condition, including cleft lip and palate
* Segmental Le Fort I osteotomy
* Adjuvant Zygomatic osteotomy
* Maxillary impaction higher than 3 mm
* Maxillary advancement greater than 5 mm
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02660216
Study Brief:
Protocol Section:
NCT02660216