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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05822271
Enrollment
20
Registered
2023-04-20
Start date
2022-01-30
Completion date
2025-10-31
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malocclusion, Angle Class III

Keywords

Surgery-First, Orthognathic, Aligner, Aesthetic Treatment

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).

Interventions

PROCEDUREOrthognathic Surgery

Type of surgery performed to correct skeletal malocclusions

Sponsors

Rio de Janeiro State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
17 Years to 35 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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 inclinationat 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.
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.
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.
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.

Countries

Brazil

Contacts

Primary ContactArthur Cunha, MSc
cunhas.arthur@gmail.com55-21-967637007
Backup ContactJose Augusto M Miguel, PhD
jamiguel66@gmail.com55-21-972821500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026