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

Rio de Janeiro State University

Status: Enrolling

Conditions: Malocclusion, Angle Class III

Treatments: Procedure: Orthognathic Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05822271

51444621.0.0000.5259

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 17 to 35 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Orthodontic Aligner treatment

Experimental group

Treatment:

Procedure: Orthognathic Surgery

Orthodontic fixed appliance treatment

Active Comparator group

Treatment:

Procedure: Orthognathic Surgery