Evaluation of Surgical Outcomes of Patients Treated With the Surgery First Approach and Aligners

Study Overview
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Brief Summary
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The purpose of this prospective study is to compare treatment outcomes and the quality of life of skeletal Class III patients treated with conventional fixed appliances and aligners undergoing Surgery-first approach. Data will be collected through validated questionnaires: OQLQ (Orthognathic Quality of Life Questionnaire), OHIP-14 (Oral Health Impact Proﬁle), SF-36 (Medical Outcomes Study 36 - Item Short-Form Health Survey) and IOTN (Index of Orthodontic Treatment Need).

Official Title
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Evaluation of Surgical Outcomes of Patients Treated With the Surgery First Approach and Aligners

Conditions
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Malocclusion, Angle Class III

Intervention / Treatment
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* Procedure: Orthognathic Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults; Skeletal malocclusion; ANB Angle zero or negative; Witts negative; Etiology: mandibular excess, a maxillary deficiency, or a combination of both; Indication for bimaxillary surgery; Exclusion Criteria: Previous orthodontic treatment; Craniofacial anomaly or previous fracture of the facial bones; Total edentulism; Deep curve of Spee; Vertical asymmetry; Any medication use that contraindicates surgical treatment.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orthodontic Aligner treatment<br> | Procedure: Orthognathic Surgery<br>* Type of surgery performed to correct skeletal malocclusions<br>|
| Active Comparator: Orthodontic fixed appliance treatment<br> | Procedure: Orthognathic Surgery<br>* Type of surgery performed to correct skeletal malocclusions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life accessed by validated questionnaires. | Comparison between quality of life changes in the two groups at the end of treatment. | at the end of orthodontic treatment (up to 2 years). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periodontal status. | Comparison between periodontal changes in the two groups at the end of the treatment. | at the end of orthodontic treatment (up to 2 years). | 
| Treatment duration. | Comparison between treatment time in the two groups at the end of the treatment. | at the end of orthodontic treatment (up to 2 years). | 
| Facial changes as measured by tomographic superimposition of the face. | Comparison between facial changes in the two groups at the end of the treatment. | at the end of orthodontic treatment (up to 2 years). | 
| Incisors inclination | Quantitative assessment of incisors inclination between the two groups as measured by tomographic superimposition at the end of orthodontic treatment. | at the end of orthodontic treatment (up to 2 years). | 
| Alveolar bone changes around incisors. | Comparison between the alveolar bone changes around incisors by tomographic. | at the end of orthodontic treatment (up to 2 years). | 
| Swelling as measured by tomographic images. | Comparison between facial swelling in the two groups after orthognathic surgery. | 12 months post-operative. | 
| Surgery stability as measured by tomographic superimposition. | Comparison between surgery stability in the two groups at the end of the treatment. | 12 months post-operative. | 
| Changes in relationship between maxilla and mandible as measured by tomographic superimposition of the cranial base. | Comparison between the changes of the relationship among maxilla and mandible in the two groups at the end of the treatment. | 12 months post-operative. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery-First, Orthognathic, Aligner, Aesthetic Treatment