RecruitingNot Applicable

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

Brazil20 participantsStarted 2022-01-30

Plain-language 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).

Who can participate

Age range

17 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Quality of life accessed by validated questionnaires.

Timeframe: at the end of orthodontic treatment (up to 2 years).

Trial details

NCT IDNCT05822271

SponsorRio de Janeiro State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08

Contact for this trial

Arthur Cunha, MSc

55-21-967637007 cunhas.arthur@gmail.com

View on ClinicalTrials.gov More Malocclusion, Angle Class III trials