Orthognathic Surgery With Clear Aligners vs Conventional Brackets

March 30, 2026 updated by: Centre Hospitalier Universitaire de Nice

Perioperative Outcomes in Orthognathic Surgery With Clear Aligners Versus Conventional Brackets: A Retrospective Comparative Study

This retrospective single-center observational study compared perioperative and early postoperative outcomes in patients undergoing orthognathic surgery after orthodontic preparation with either conventional fixed brackets or clear aligners. The objective was to assess whether aligner-based preparation was associated with differences in intraoperative occlusal management, including fixation stability, technical difficulties, need for additional intraoperative adaptations, and early occlusal outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

420

Contacts and Locations

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

Study Locations

  • France
    • Alpes Maritimes
      • Nice, Alpes Maritimes, France, 06000
        • CHU de Nice

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
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients treated for dentofacial deformities requiring orthognathic surgery at a single tertiary referral center in France.

Description

Inclusion Criteria:

  • Patients undergoing orthognathic surgery at the study center during the study period.
  • Orthodontic preparation with either conventional fixed brackets or clear aligners.
  • Age 16 years or older.
  • Available perioperative clinical records and required imaging data.

Exclusion Criteria:

  • Missing perioperative data required for the analysis.
  • Missing preoperative or postoperative imaging required for assessment.
  • Explicit opposition to the reuse of data, if applicable.
  • Syndromic conditions.
  • Cleft-related deformities.
  • Distraction osteogenesis.
  • Secondary surgery.
  • Follow-up < 6 months.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Conventional brackets group
Device: Conventional fixed orthodontic appliances
Orthodontic preparation with fixed multi-bracket appliances in place at the time of surgery, providing conventional anchorage for intermaxillary fixation and intraoperative occlusal control.
Clear aligners group
Device: Clear aligner therapy
Orthodontic preparation with clear aligners and no fixed brackets at the time of surgery. Alternative intraoperative strategies may be required to achieve planned occlusal positioning and stabilization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite perioperative occlusal management event
Time Frame: From surgery to the immediate postoperative assessment
Number of composite perioperative occlusal management event for each patient
From surgery to the immediate postoperative assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stable intermaxillary fixation
Time Frame: From begining to the end of the surgery
Number of stable intermaxilary fixation or not for each patient
From begining to the end of the surgery
Surgical revision after surgery
Time Frame: After surgery and the next 6 months
Number of patient with postoperative complications 6 months after surgery
After surgery and the next 6 months

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Nice

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 1, 2020

Primary Completion (Actual)

September 3, 2025

Study Completion (Actual)

September 3, 2025

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26IUFC02

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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