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

Not Applicable

Recruiting

• Conditions: Malocclusion, Angle Class III
• Interventions: Procedure: Orthognathic Surgery

• Registration Number: NCT05822271
• Lead Sponsor: Rio de Janeiro State University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-30
• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-04-18
• Study First Posted: 2023-04-20
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-28
• Last Update Posted: 2024-12-02
• Primary Completion: 2025-08
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orthodontic Aligner treatment	Orthognathic Surgery	-
Orthodontic fixed appliance treatment	Orthognathic Surgery	-

Primary Outcome Measures

Name	Time	Method
Quality of life accessed by validated questionnaires.	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 Outcome Measures

Name	Time	Method
Periodontal status.	at the end of orthodontic treatment (up to 2 years).	Comparison between periodontal changes in the two groups at the end of the treatment.
Treatment duration.	at the end of orthodontic treatment (up to 2 years).	Comparison between treatment time in the two groups at the end of the treatment.
Facial changes as measured by tomographic superimposition of the face.	at the end of orthodontic treatment (up to 2 years).	Comparison between facial changes in the two groups at the end of the treatment.
Incisors inclination	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.
Alveolar bone changes around incisors.	at the end of orthodontic treatment (up to 2 years).	Comparison between the alveolar bone changes around incisors by tomographic.
Swelling as measured by tomographic images.	12 months post-operative.	Comparison between facial swelling in the two groups after orthognathic surgery.
Surgery stability as measured by tomographic superimposition.	12 months post-operative.	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.	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.

Trial Locations

Locations (1)

Rio de Janeiro State University; 🇧🇷 Rio De Janeiro, Brazil