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RecruitingNCT05822271Updated Dec 2, 2024

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

An interventional study of Orthognathic Surgery in Malocclusion, Angle Class III, sponsored by Rio de Janeiro State University. Recruiting at 1 site in Brazil. Open to participants aged 17 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-02.

Sponsored by Rio de Janeiro State University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 2 months after the study started (first participant enrolled Jan 2022, registered Mar 2023).
  • Started Jan 2022; still recruiting 4 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
17 Years to 35 Years
Sex
All
01

Study 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).

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Conditions studied

  • Malocclusion, Angle Class III

Keywords

  • Surgery-First
  • Orthognathic
  • Aligner
  • Aesthetic Treatment
03

In context

Malocclusion, Angle Class III

57 studies on the registry are indexed under Malocclusion, Angle Class III; 11 are open to participants now.

This study's planned enrollment of 20 is below the median of 32 across 53 interventional studies indexed under Malocclusion, Angle Class III.

Browse Malocclusion, Angle Class III studies →

Lead sponsor

Rio de Janeiro State University is the lead sponsor of 62 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
17 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Orthodontic Aligner treatment

    Procedure: Orthognathic Surgery

  • Active comparator
    Orthodontic fixed appliance treatment

    Procedure: Orthognathic Surgery

Interventions

  • ProcedureOrthognathic Surgery

    Type of surgery performed to correct skeletal malocclusions

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What researchers measure

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.

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

Secondary outcomes

  1. Periodontal status.

    Comparison between periodontal changes in the two groups at the end of the treatment.

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

  2. Treatment duration.

    Comparison between treatment time in the two groups at the end of the treatment.

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

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

    Comparison between facial changes in the two groups at the end of the treatment.

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

  4. Incisors inclination

    Quantitative assessment of incisors inclination between the two groups as measured by tomographic superimposition at the end of orthodontic treatment.

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

  5. Alveolar bone changes around incisors.

    Comparison between the alveolar bone changes around incisors by tomographic.

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

  6. Swelling as measured by tomographic images.

    Comparison between facial swelling in the two groups after orthognathic surgery.

    Time frame: 12 months post-operative.

  7. Surgery stability as measured by tomographic superimposition.

    Comparison between surgery stability in the two groups at the end of the treatment.

    Time frame: 12 months post-operative.

  8. 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.

    Time frame: 12 months post-operative.

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Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 24713569 ↗
  • 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. PubMed 26827973 ↗
  • 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. PubMed 20186090 ↗
  • 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. PubMed 27021449 ↗
  • 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. PubMed 28554450 ↗
  • 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. PubMed 30384934 ↗
  • 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. PubMed 24749702 ↗
  • 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. PubMed 17346581 ↗
  • 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. PubMed 21257249 ↗
  • 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. PubMed 20552809 ↗
  • 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. PubMed 32100114 ↗
  • 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. PubMed 30076359 ↗
  • 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. PubMed 37026606 ↗

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05822271
Lead sponsor
Rio de Janeiro State University
Responsible party
Arthur Cunha (Clinical Professor, Rio de Janeiro State University) — Principal investigator
First posted
Apr 20, 2023
Start date
Jan 30, 2022
Primary completion
Aug 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
Dec 2, 2024

Study contacts

Arthur Cunha, MSc
Contact
cunhas.arthur@gmail.com
55-21-967637007
Jose Augusto M Miguel, PhD
Contact
jamiguel66@gmail.com
55-21-972821500

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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