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Evaluation of surgical outcomes of patients treated with the Surgery Protocol Before the Orthodontic treatment

Evaluation of surgical outcomes of patients treated with the Surgery First Approach and Aligners

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-28czd8q
Enrollment
Unknown
Registered
2023-11-07
Start date
2021-01-10
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Prognathism

Interventions

This study is a two-arm (1:1) randomized double-blinded clinical trial. Forty patients will be selected, divided into two groups: Group 1 treated with aligners (Invisalign)
Group 2 treated with conventional fixed orthodontic. Data will be collected through widely validated questionnaires to evaluate the functional/esthetic results and quality of life. Complete clinical
6 months (T3), 1 year (T4), and after treatment without orthodontic appliances (T5).

Sponsors

Universidade do Estado do Rio de Janeiro
Lead Sponsor
Universidade do Estado do Rio de Janeiro
Collaborator

Eligibility

Age
17 Years to No maximum

Inclusion criteria

Inclusion criteria: Adults; Skeletal malocclusion; ANB (cephalometric analysis widely used in Orthodontics) zero or negative; Witts negative; Mandibular excess, a maxillary deficiency, or a combination of both; Indication for bimaxillary surgery

Exclusion criteria

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 frame
It is expected positive scores related to quality of life in the patients treated with orthodontic aligners and orthodontic brackets associated with the Surgery First Approach. Presenting stable esthetic and functional results at the end of treatment

Secondary

MeasureTime frame
It is expected to observe quality of life scores improvement in terms of comfort, esthetics and functional treatment on the experimental group compared to the control group.

Countries

Brazil

Contacts

Public ContactArthur Cunha

Universidade do Estado do Rio de Janeiro

cep@hupe.uerj.br+55-21-2868-8253

Outcome results

None listed

Source: REBEC (via WHO ICTRP)