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

Rio de Janeiro State University1 site in 1 country20 target enrollmentJanuary 30, 2022

ConditionsMalocclusion, Angle Class III

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Malocclusion, Angle Class III
Sponsor: Rio de Janeiro State University
Enrollment: 20
Locations: 1
Primary Endpoint: Quality of life accessed by validated questionnaires.
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

January 30, 2022

End Date

October 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Rio de Janeiro State University

Responsible Party

Principal Investigator

Arthur Cunha

Clinical Professor

Rio de Janeiro State University

Eligibility Criteria

Inclusion Criteria

•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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Periodontal status.(at the end of orthodontic treatment (up to 2 years).)
Treatment duration.(at the end of orthodontic treatment (up to 2 years).)
Changes in relationship between maxilla and mandible as measured by tomographic superimposition of the cranial base.(12 months post-operative.)
Facial changes as measured by tomographic superimposition of the face.(at the end of orthodontic treatment (up to 2 years).)
Incisors inclination(at the end of orthodontic treatment (up to 2 years).)
Alveolar bone changes around incisors.(at the end of orthodontic treatment (up to 2 years).)
Swelling as measured by tomographic images.(12 months post-operative.)
Surgery stability as measured by tomographic superimposition.(12 months post-operative.)