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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age17-35
SponsorRio de Janeiro State University

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults;

Skeletal malocclusion;

ANB Angle zero or negative;

Witts negative;

Disqualifiers

Previous orthodontic treatment;

Craniofacial anomaly or previous fracture of the facial bones;

Total edentulism;

Deep curve of Spee;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Orthognathic Surgery

    Procedure/Surgery

    Type of surgery performed to correct skeletal malocclusions

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Orthodontic Aligner treatmentExperimental treatment 1 intervention
Group B: Orthodontic fixed appliance treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Quality of life accessed by validated questionnaires.

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 outcomes

1

Periodontal status.

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).
2

Treatment duration.

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).
3

Facial changes as measured by tomographic superimposition of the face.

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).
4

Incisors inclination

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).

Other outcomes

Sponsors and contacts

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