- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05822271
Evaluation of Surgical Outcomes of Patients Treated With the Surgery First Approach and Aligners
May 3, 2023 updated by: Arthur Cunha, Rio de Janeiro State University
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Arthur Cunha, MSc
- Phone Number: 55-21-967637007
- Email: cunhas.arthur@gmail.com
Study Contact Backup
- Name: Jose Augusto M Miguel, PhD
- Phone Number: 55-21-972821500
- Email: jamiguel66@gmail.com
Study Locations
-
-
-
Rio De Janeiro, Brazil, 20551-030
- Recruiting
- Rio de Janeiro State University
-
Sub-Investigator:
- Jose Augusto M Miguel, PhD
-
Contact:
- Arthur Cunha, MSc
- Phone Number: +5521967637007
- Email: cunhas.arthur@gmail.com
-
Contact:
- Jose Augusto M Miguel, PhD
- Phone Number: +5521972821500
- Email: jamiguel66@gmail.com
-
Principal Investigator:
- Arthur Cunha, MSc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Orthodontic Aligner treatment
|
Type of surgery performed to correct skeletal malocclusions
|
Active Comparator: Orthodontic fixed appliance treatment
|
Type of surgery performed to correct skeletal malocclusions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
at the end of orthodontic treatment (up to 2 years).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Periodontal status.
Time Frame: at the end of orthodontic treatment (up to 2 years).
|
Comparison between periodontal changes in the two groups at the end of the treatment.
|
at the end of orthodontic treatment (up to 2 years).
|
Treatment duration.
Time Frame: at the end of orthodontic treatment (up to 2 years).
|
Comparison between treatment time in the two groups at the end of the treatment.
|
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).
|
Comparison between facial changes in the two groups at the end of the treatment.
|
at the end of orthodontic treatment (up to 2 years).
|
Incisors inclination
Time Frame: at the end of orthodontic treatment (up to 2 years).
|
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).
|
Alveolar bone changes around incisors.
Time Frame: at the end of orthodontic treatment (up to 2 years).
|
Comparison between the alveolar bone changes around incisors by tomographic.
|
at the end of orthodontic treatment (up to 2 years).
|
Swelling as measured by tomographic images.
Time Frame: 12 months post-operative.
|
Comparison between facial swelling in the two groups after orthognathic surgery.
|
12 months post-operative.
|
Surgery stability as measured by tomographic superimposition.
Time Frame: 12 months post-operative.
|
Comparison between surgery stability in the two groups at the end of the treatment.
|
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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 30, 2022
Primary Completion (Anticipated)
August 1, 2025
Study Completion (Anticipated)
October 1, 2025
Study Registration Dates
First Submitted
March 31, 2023
First Submitted That Met QC Criteria
April 18, 2023
First Posted (Actual)
April 20, 2023
Study Record Updates
Last Update Posted (Estimate)
May 8, 2023
Last Update Submitted That Met QC Criteria
May 3, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Congenital Abnormalities
- Musculoskeletal Diseases
- Stomatognathic Diseases
- Tooth Diseases
- Stomatognathic System Abnormalities
- Jaw Abnormalities
- Jaw Diseases
- Maxillofacial Abnormalities
- Craniofacial Abnormalities
- Musculoskeletal Abnormalities
- Mandibular Diseases
- Malocclusion
- Prognathism
- Malocclusion, Angle Class III
Other Study ID Numbers
- 51444621.0.0000.5259
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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