Malocclusion, Angle Class IIINCT05822271
Evaluation of Surgical Outcomes of Patients Treated With the Surgery First Approach and Aligners
A study testing Orthognathic Surgery in people with Malocclusion, Angle Class III, run by Rio de Janeiro State University at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 17 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Angle Class III
- What is being tested?
- Orthognathic Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jan 2022to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Rio de Janeiro State University
Rio de Janeiro, 20551-030
Arthur Cunha, MSc, +5521967637007, cunhas.arthur@gmail.com
Jose Augusto M Miguel, PhD, +5521972821500, jamiguel66@gmail.com
About this study
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
- Being tested
- Orthognathic Surgery
- Keywords
- Surgery-First, Orthognathic, Aligner, Aesthetic Treatment
- Medical subject headings
- Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthognathic SurgeryProcedure or surgery
Type of surgery performed to correct skeletal malocclusions
| Study group | Role | What they receive |
|---|---|---|
| Orthodontic Aligner treatment | Experimental | Not described Receives: Procedure: Orthognathic Surgery |
| Orthodontic fixed appliance treatment | Active comparator | Not described Receives: Procedure: Orthognathic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life accessed by validated questionnaires.
Comparison between quality of life changes in the two groups at the end of treatment.
Measured: at the end of orthodontic treatment (up to 2 years).
Secondary outcomes (8)
Periodontal status.
Comparison between periodontal changes in the two groups at the end of the treatment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months post-operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start30 Jan 2022
- Primary completionAug 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Malocclusion, Angle Class IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arthur Cunha, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822271
- Sponsor's protocol ID
- 51444621.0.0000.5259
- Status last verified
- Nov 2024
- First submitted
- 31 Mar 2023
- Last updated
- 2 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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 24713569Palomares 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 26827973Baek 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 20186090Peiro-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 27021449Feu 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 28554450Flores-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 30384934Buschang 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.
PubMed 24749702Miller 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 17346581Liou 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 21257249Villegas 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 20552809Liao 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 32100114Liao 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 30076359de 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 37026606Cunha 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.
PubMed 41200809
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Surgical Outcomes of Patients Treated With the Surgery First Approach and Aligners
- ClinicalTrials.gov ID
- NCT05822271
- Acronym / sponsor ID
- 51444621.0.0000.5259
- Conditions
- Malocclusion, Angle Class III
- Keywords
- Surgery-First, Orthognathic, Aligner, Aesthetic Treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthodontic Aligner treatment | Experimental | Procedure: Orthognathic Surgery |
| Orthodontic fixed appliance treatment | Active comparator | Procedure: Orthognathic Surgery |
Who may qualify
- Ages
- 17 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Adults;
- Skeletal malocclusion;
- ANB Angle zero or negative;
- Witts negative;
- Etiology: mandibular excess, a maxillary deficiency, or a combination of both;
Key exclusion criteria (6 listed)
- Previous orthodontic treatment;
- Craniofacial anomaly or previous fracture of the facial bones;
- Total edentulism;
- Deep curve of Spee;
- Vertical asymmetry;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthognathic SurgeryType of surgery performed to correct skeletal malocclusions | Procedure or surgery | Orthodontic Aligner treatment, Orthodontic fixed appliance treatment |
Primary outcome
Quality of life accessed by validated questionnaires.
Time frame: at the end of orthodontic treatment (up to 2 years).
Comparison between quality of life changes in the two groups at the end of treatment.
8 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Background: PubMed 24713569Miguel 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.
- Background: PubMed 26827973Palomares 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.
- Background: PubMed 20186090Baek 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.
- Background: PubMed 27021449Peiro-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.
- Background: PubMed 28554450Feu 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.
- Background: PubMed 30384934Flores-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.
- Background: PubMed 24749702Buschang 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.
- Background: PubMed 17346581Miller 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.
- Background: PubMed 21257249Liou 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.
- Background: PubMed 20552809Villegas 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.
- Background: PubMed 32100114Liao 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.
- Background: PubMed 30076359Liao 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthognathic Surgery in people with Malocclusion, Angle Class III, run by Rio de Janeiro State University at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arthur Cunha, MSc (55-21-967637007, cunhas.arthur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life accessed by validated questionnaires. (time frame: at the end of orthodontic treatment (up to 2 years).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05822271, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.