Dentofacial Deformities
Conditions
Interventions
This is a randomized, double-blind clinical study. Control group: 14 patients with indications for mandibular advancement will be treated with conventional sagittal split osteotomy. Experimental group
Sponsors
Hospital Universitário Oswaldo Cruz
Hospital Universitário Oswaldo Cruz
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with facial Pattern II or the sagittal component of Pattern II; Patients who sought outpatient care for the reported problem at Oswaldo Cruz University Hospital; Be at least 18 years of age. Individuals of both sexes will be included in the sample.
Exclusion criteria
Exclusion criteria: Patients who have not signed the consent form or with: Incomplete documentation; Trauma sequelae; Craniofacial syndromes; Disabling systemic comorbidities; In treatment of OSAS through other modalities; Presence of an impacted, impacted or out-of-occlusion third molar; Need for reoperation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to identify a difference between groups in the lingual cleavage pattern (separation or split). Verified by means of Computed Tomography obtained postoperatively and categorized according to the Plooij classification (2009). It is expected to find a relevant difference with a greater tendency for posterior separation for the Modified Osteotomy (experimental group).;A volumetric assessment of the upper airway will be performed postoperatively, and the results will be compared between the groups. The analysis will be performed using helical computed tomography using Dolphin 11.95 software and the specific "Sinus/Airway" tool, which will determine numbers in cubic millimeters after correctly delimiting the area, following the Guijaro-Martinez (2013) protocol. It is expected that no significant differences will be found between the groups. And to prove that Modified Osteotomy can also be used to widen the airways.;The degree of paresthesia (neurosensory disturbance in the innervation area of the inferior alveolar nerve) will be assessed using the validated Semmes-Westein Filament Test. This test will be performed bilaterally on the lip and chin, thus assessing four areas. The filaments have different diameters (identified by color) and are capable of exerting different amounts of pressure (in grams) on the tissue until they bend. The color of the thinnest filament that the patient felt touched will be recorded for each area. It is expected that a lower degree of paresthesia will be found in the experimental group, supporting the hypothesis that Modified Osteotomy may be less damaging to the Inferior Alveolar Nerve. | — |
Secondary
| Measure | Time frame |
|---|---|
| The time required to perform each osteotomy will be assessed to determine which can be performed in the shortest time. The time will be counted using a stopwatch held by a team member outside the surgical area. The time will be measured from the start of the osteotomy to the end of the separation (cleavage). It is expected that the modified osteotomy can be performed in less time due to its shorter oblique path.;The intraoperative status of the nerve will be assessed through direct visual inspection after cleavage and separation of the mandibular segments. For this purpose, we will use the modified Verweij (2015) classification, which will categorize it into four types (exposed nerve, non-exposed nerve, entrapped in the proximal segment, or ruptured nerve). A higher rate of nerve preservation is expected in the experimental group.;Oximetry (lowest desaturation) and AHI (Apnea Hypopnea Index) data will be evaluated and compared between groups. Both parameters will be obtained through overnight polysomnography at Oswaldo Cruz University Hospital. It is expected that no significant differences will be found between the groups. This demonstrates that Modified Osteotomy can also be used to improve breathing during sleep.;Using the Epworth Sleepiness Scale questionnaire, patients' level of daytime sleepiness will be assessed to determine the extent to which the surgeries improved sleep and, consequently, daytime sleepiness. No significant differences are expected between the groups. | — |
Countries
Brazil
Contacts
Public ContactThalles Suassuna
Faculdade Odontologia de Pernambuco
Outcome results
None listed