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

November 28, 2024 updated by: Arthur Cunha, Rio de Janeiro State University
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • Rio De Janeiro, Brazil, 20551-030
        • Recruiting
        • Rio de Janeiro State University
        • Sub-Investigator:
          • Jose Augusto M Miguel, PhD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Arthur Cunha, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Orthodontic Aligner treatment
Procedure: Orthognathic Surgery
Type of surgery performed to correct skeletal malocclusions
Active Comparator: Orthodontic fixed appliance treatment
Procedure: Orthognathic Surgery
Type of surgery performed to correct skeletal malocclusions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life accessed by validated questionnaires.
Time Frame: 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.
at the end of orthodontic treatment (up to 2 years).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periodontal status.
Time Frame: at the end of orthodontic treatment (up to 2 years).
Comparison between periodontal changes in the two groups at the end of the treatment.
at the end of orthodontic treatment (up to 2 years).
Treatment duration.
Time Frame: at the end of orthodontic treatment (up to 2 years).
Comparison between treatment time in the two groups at the end of the treatment.
at the end of orthodontic treatment (up to 2 years).
Facial changes as measured by tomographic superimposition of the face.
Time Frame: at the end of orthodontic treatment (up to 2 years).
Comparison between facial changes in the two groups at the end of the treatment.
at the end of orthodontic treatment (up to 2 years).
Incisors inclination
Time Frame: at 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.
at the end of orthodontic treatment (up to 2 years).
Alveolar bone changes around incisors.
Time Frame: at the end of orthodontic treatment (up to 2 years).
Comparison between the alveolar bone changes around incisors by tomographic.
at the end of orthodontic treatment (up to 2 years).
Swelling as measured by tomographic images.
Time Frame: 12 months post-operative.
Comparison between facial swelling in the two groups after orthognathic surgery.
12 months post-operative.
Surgery stability as measured by tomographic superimposition.
Time Frame: 12 months post-operative.
Comparison between surgery stability in the two groups at the end of the treatment.
12 months post-operative.
Changes in relationship between maxilla and mandible as measured by tomographic superimposition of the cranial base.
Time Frame: 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.
12 months post-operative.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rio de Janeiro State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2022

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

April 18, 2023

First Posted (Actual)

April 20, 2023

Study Record Updates

Last Update Posted (Estimated)

December 2, 2024

Last Update Submitted That Met QC Criteria

November 28, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 51444621.0.0000.5259

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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