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Recruiting NCT05822271

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

No phase Interventional Malocclusion, Angle Class III

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Orthognathic Surgery.
Who it may be relevant to
Registry conditions: Malocclusion, Angle Class III. Basic parameters: 17 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

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

Primary outcome measures

  • Quality of life accessed by validated questionnaires. [Time frame: at the end of orthodontic treatment (up to 2 years).]
Secondary outcome measures (8)
  • Periodontal status. [Time frame: at the end of orthodontic treatment (up to 2 years).]
  • Treatment duration. [Time frame: at the end of orthodontic treatment (up to 2 years).]
  • Facial changes as measured by tomographic superimposition of the face. [Time frame: at the end of orthodontic treatment (up to 2 years).]
  • Incisors inclination [Time frame: at the end of orthodontic treatment (up to 2 years).]
  • Alveolar bone changes around incisors. [Time frame: at the end of orthodontic treatment (up to 2 years).]
  • Swelling as measured by tomographic images. [Time frame: 12 months post-operative.]
  • Surgery stability as measured by tomographic superimposition. [Time frame: 12 months post-operative.]
  • Changes in relationship between maxilla and mandible as measured by tomographic superimposition of the cranial base. [Time frame: 12 months post-operative.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Rio de Janeiro State University — Rio de Janeiro

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. Epub 2013 Nov 18. PMID 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. PMID 17346581

Identifiers

NCT: NCT05822271 · 51444621.0.0000.5259

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗