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

NCT05822271 | Recruiting

• 1 other identifier: 51444621.0.0000.5259
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Malocclusion, Angle Class III

Keywords

Surgery-First; Orthognathic; Aligner; Aesthetic Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Periodontal status.

  at the end of orthodontic treatment (up to 2 years).

• Treatment duration.

  at the end of orthodontic treatment (up to 2 years).

• Facial changes as measured by tomographic superimposition of the face.

  at the end of orthodontic treatment (up to 2 years).

• Incisors inclination

  at the end of orthodontic treatment (up to 2 years).

• Alveolar bone changes around incisors.

  at the end of orthodontic treatment (up to 2 years).

Study Arms (2)

Orthodontic Aligner treatment

EXPERIMENTAL

Procedure: Orthognathic Surgery

Orthodontic fixed appliance treatment

ACTIVE COMPARATOR

Procedure: Orthognathic Surgery

Interventions

Orthognathic Surgery PROCEDURE

Type of surgery performed to correct skeletal malocclusions

Orthodontic Aligner treatment; Orthodontic fixed appliance treatment

Eligibility Criteria

• Age: 17 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rio de Janeiro State University: lead

Study Sites (1)

Rio de Janeiro State University

Rio de Janeiro, 20551-030, Brazil

RECRUITING

Related Publications (14)

• 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.

  PMID: 24713569 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.

  PMID: 26827973 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.

  PMID: 20186090 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.

  PMID: 27021449 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.

  PMID: 28554450 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.

  PMID: 30384934 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.

  PMID: 24749702 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.

  PMID: 17346581 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.

  PMID: 21257249 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.

  PMID: 20552809 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.

  PMID: 32100114 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.

  PMID: 30076359 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.

  PMID: 37026606 BACKGROUND

• 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.

  PMID: 41200809 DERIVED

MeSH Terms

Conditions

Malocclusion, Angle Class III

Interventions

Orthognathic Surgery

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Surgery, Oral; Dentistry

Central Study Contacts

Arthur Cunha, MSc

CONTACT

55-21-967637007; cunhas.arthur@gmail.com

Jose Augusto M Miguel, PhD

CONTACT

55-21-972821500; jamiguel66@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 20, 2023
• Study Start: January 30, 2022
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)