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

Malocclusion, Angle Class III Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05822271
• Other study ID #: 51444621.0.0000.5259
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2022
• Est. completion date: October 2025

Study information

• Verified date: May 2023
• Source: Rio de Janeiro State University
• Contact: Arthur Cunha, MSc
• Phone: 55-21-967637007
• Email: cunhas.arthur[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malocclusion
• Malocclusion, Angle Class III
• Prognathism

Intervention

Procedure:
• Orthognathic Surgery
Type of surgery performed to correct skeletal malocclusions

Locations

Country	Name	City	State
Brazil	Rio de Janeiro State University	Rio De Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Rio de Janeiro State University

Country where clinical trial is conducted

Brazil, 

References & Publications (13)

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. — View Citation

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. — View Citation

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 Apr 7:25555. doi: 10.4317/medoral.25555. Online ahead of print. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	Swelling as measured by tomographic images.	Comparison between facial swelling in the two groups after orthognathic surgery.	12 months post-operative.
Secondary	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.
Secondary	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.