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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orthodontic Aligner treatment | Experimental |
| |
| Orthodontic fixed appliance treatment | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orthognathic Surgery | Procedure | Type of surgery performed to correct skeletal malocclusions |
|
| 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). |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arthur Cunha, MSc | Contact | 55-21-967637007 | cunhas.arthur@gmail.com | |
| Jose Augusto M Miguel, PhD | Contact | 55-21-972821500 | jamiguel66@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rio de Janeiro State University | Recruiting | Rio de Janeiro | 20551-030 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24713569 | Background | Miguel JA, Palomares NB, Feu D. Life-quality of orthognathic surgery patients: the search for an integral diagnosis. Dental Press J Orthod. 2014 Jan-Feb;19(1):123-37. doi: 10.1590/2176-9451.19.1.123-137.sar. | |
| 26827973 | Background | Palomares NB, Celeste RK, Miguel JA. Impact of orthosurgical treatment phases on oral health-related quality of life. Am J Orthod Dentofacial Orthop. 2016 Feb;149(2):171-81. doi: 10.1016/j.ajodo.2015.07.032. |
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| ID | Term |
|---|---|
| D008313 | Malocclusion, Angle Class III |
| ID | Term |
|---|---|
| D008310 | Malocclusion |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D057909 | Orthognathic Surgery |
| ID | Term |
|---|---|
| D013515 | Surgery, Oral |
| D003813 | Dentistry |
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| 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. |
| 20186090 | Background | Baek SH, Ahn HW, Kwon YH, Choi JY. Surgery-first approach in skeletal class III malocclusion treated with 2-jaw surgery: evaluation of surgical movement and postoperative orthodontic treatment. J Craniofac Surg. 2010 Mar;21(2):332-8. doi: 10.1097/SCS.0b013e3181cf5fd4. |
| 27021449 | Background | Peiro-Guijarro MA, Guijarro-Martinez R, Hernandez-Alfaro F. Surgery first in orthognathic surgery: A systematic review of the literature. Am J Orthod Dentofacial Orthop. 2016 Apr;149(4):448-62. doi: 10.1016/j.ajodo.2015.09.022. |
| 28554450 | Background | Feu D, de Oliveira BH, Palomares NB, Celeste RK, Miguel JAM. Oral health-related quality of life changes in patients with severe Class III malocclusion treated with the 2-jaw surgery-first approach. Am J Orthod Dentofacial Orthop. 2017 Jun;151(6):1048-1057. doi: 10.1016/j.ajodo.2016.10.034. |
| 30384934 | Background | Flores-Mir C, Brandelli J, Pacheco-Pereira C. Patient satisfaction and quality of life status after 2 treatment modalities: Invisalign and conventional fixed appliances. Am J Orthod Dentofacial Orthop. 2018 Nov;154(5):639-644. doi: 10.1016/j.ajodo.2018.01.013. |
| 24749702 | Background | Buschang PH, Shaw SG, Ross M, Crosby D, Campbell PM. Comparative time efficiency of aligner therapy and conventional edgewise braces. Angle Orthod. 2014 May;84(3):391-6. doi: 10.2319/062113-466. Epub 2013 Nov 18. |
| 17346581 | Background | Miller KB, McGorray SP, Womack R, Quintero JC, Perelmuter M, Gibson J, Dolan TA, Wheeler TT. A comparison of treatment impacts between Invisalign aligner and fixed appliance therapy during the first week of treatment. Am J Orthod Dentofacial Orthop. 2007 Mar;131(3):302.e1-9. doi: 10.1016/j.ajodo.2006.05.031. |
| 21257249 | Background | Liou EJ, Chen PH, Wang YC, Yu CC, Huang CS, Chen YR. Surgery-first accelerated orthognathic surgery: orthodontic guidelines and setup for model surgery. J Oral Maxillofac Surg. 2011 Mar;69(3):771-80. doi: 10.1016/j.joms.2010.11.011. Epub 2011 Jan 22. |
| 20552809 | Background | Villegas C, Uribe F, Sugawara J, Nanda R. Expedited correction of significant dentofacial asymmetry using a "surgery first" approach. J Clin Orthod. 2010 Feb;44(2):97-103; quiz 105. No abstract available. |
| 32100114 | Background | Liao YF, Chen YA, Chen YC, Chen YR. Outcomes of conventional versus virtual surgical planning of orthognathic surgery using surgery-first approach for class III asymmetry. Clin Oral Investig. 2020 Apr;24(4):1509-1516. doi: 10.1007/s00784-020-03241-4. Epub 2020 Feb 25. |
| 30076359 | Background | Liao YF, Lo SH. Surgical Occlusion Setup in Correction of Skeletal Class III Deformity Using Surgery-First Approach: Guidelines, Characteristics and Accuracy. Sci Rep. 2018 Aug 3;8(1):11673. doi: 10.1038/s41598-018-30124-2. |
| 37026606 | Background | de Leyva P, Eslava JM, Hernandez-Alfaro F, Acero J. Orthognathic surgery and aligners. A comparative assessment of periodontal health and quality of life in postsurgical orthodontic treatment with aligners versus traditional fixed appliances: a randomized controlled trial. Med Oral Patol Oral Cir Bucal. 2023 May 1;28(3):e208-e216. doi: 10.4317/medoral.25555. |
| 41200809 | Derived | Cunha A, Silva LKA, da Silveira HM, Miguel JAM. Impact on Oral Health-Related Quality of Life in Skeletal Class III Patients Treated With Orthognathic Surgery-First Approach Using Orthodontic Aligners or Fixed Appliances: A Controlled Clinical Study. Orthod Craniofac Res. 2026 Feb;29(1):112-121. doi: 10.1111/ocr.70054. Epub 2025 Nov 7. |