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

Primary Purpose

Malocclusion, Angle Class III

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Orthognathic Surgery
Sponsored by
Rio de Janeiro State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion, Angle Class III focused on measuring Surgery-First, Orthognathic, Aligner, Aesthetic Treatment

Eligibility Criteria

17 Years - 35 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Rio de Janeiro State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Orthodontic Aligner treatment

Orthodontic fixed appliance treatment

Arm Description

Outcomes

Primary Outcome Measures

Quality of life accessed by validated questionnaires.
Comparison between quality of life changes in the two groups at the end of treatment.

Secondary Outcome Measures

Periodontal status.
Comparison between periodontal changes in the two groups at the end of the treatment.
Treatment duration.
Comparison between treatment time in the two groups at the end of the treatment.
Facial changes as measured by tomographic superimposition of the face.
Comparison between facial changes in the two groups at the end of the treatment.
Incisors inclination
Quantitative assessment of incisors inclination between the two groups as measured by tomographic superimposition at the end of orthodontic treatment.
Alveolar bone changes around incisors.
Comparison between the alveolar bone changes around incisors by tomographic.
Swelling as measured by tomographic images.
Comparison between facial swelling in the two groups after orthognathic surgery.
Surgery stability as measured by tomographic superimposition.
Comparison between surgery stability in the two groups at the end of the treatment.
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.

Full Information

First Posted
March 31, 2023
Last Updated
May 3, 2023
Sponsor
Rio de Janeiro State University
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1. Study Identification

Unique Protocol Identification Number
NCT05822271
Brief Title
Evaluation of Surgical Outcomes of Patients Treated With the Surgery First Approach and Aligners
Official Title
Evaluation of Surgical Outcomes of Patients Treated With the Surgery First Approach and Aligners
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2022 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rio de Janeiro State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Angle Class III
Keywords
Surgery-First, Orthognathic, Aligner, Aesthetic Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Orthodontic Aligner treatment
Arm Type
Experimental
Arm Title
Orthodontic fixed appliance treatment
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Orthognathic Surgery
Intervention Description
Type of surgery performed to correct skeletal malocclusions
Primary Outcome Measure Information:
Title
Quality of life accessed by validated questionnaires.
Description
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 Outcome Measure Information:
Title
Periodontal status.
Description
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).
Title
Treatment duration.
Description
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).
Title
Facial changes as measured by tomographic superimposition of the face.
Description
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).
Title
Incisors inclination
Description
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).
Title
Alveolar bone changes around incisors.
Description
Comparison between the alveolar bone changes around incisors by tomographic.
Time Frame
at the end of orthodontic treatment (up to 2 years).
Title
Swelling as measured by tomographic images.
Description
Comparison between facial swelling in the two groups after orthognathic surgery.
Time Frame
12 months post-operative.
Title
Surgery stability as measured by tomographic superimposition.
Description
Comparison between surgery stability in the two groups at the end of the treatment.
Time Frame
12 months post-operative.
Title
Changes in relationship between maxilla and mandible as measured by tomographic superimposition of the cranial base.
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arthur Cunha, MSc
Phone
55-21-967637007
Email
cunhas.arthur@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Augusto M Miguel, PhD
Phone
55-21-972821500
Email
jamiguel66@gmail.com
Facility Information:
Facility Name
Rio de Janeiro State University
City
Rio De Janeiro
ZIP/Postal Code
20551-030
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arthur Cunha, MSc
Phone
+5521967637007
Email
cunhas.arthur@gmail.com
First Name & Middle Initial & Last Name & Degree
Jose Augusto M Miguel, PhD
Phone
+5521972821500
Email
jamiguel66@gmail.com
First Name & Middle Initial & Last Name & Degree
Arthur Cunha, MSc
First Name & Middle Initial & Last Name & Degree
Jose Augusto M Miguel, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
24713569
Citation
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.
Results Reference
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PubMed Identifier
26827973
Citation
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.
Results Reference
background
PubMed Identifier
20186090
Citation
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.
Results Reference
background
PubMed Identifier
27021449
Citation
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.
Results Reference
background
PubMed Identifier
28554450
Citation
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.
Results Reference
background
PubMed Identifier
30384934
Citation
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.
Results Reference
background
PubMed Identifier
24749702
Citation
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.
Results Reference
background
PubMed Identifier
17346581
Citation
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.
Results Reference
background
PubMed Identifier
21257249
Citation
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.
Results Reference
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PubMed Identifier
20552809
Citation
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.
Results Reference
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PubMed Identifier
32100114
Citation
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.
Results Reference
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PubMed Identifier
30076359
Citation
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.
Results Reference
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PubMed Identifier
37026606
Citation
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.
Results Reference
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Evaluation of Surgical Outcomes of Patients Treated With the Surgery First Approach and Aligners

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