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OpenTrials
Completed

NCT Number: NCT07511296

Orthognathic Surgery With Clear Aligners vs Conventional Brackets

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.

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Key information

Conditions

Dental Deformity Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Malocclusion Orthognathic Surgery Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nice

Nice, Alpes Maritimes, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional fixed orthodontic appliances

Device

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 aligner therapy

Device

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.

Primary outcomes

  1. Composite perioperative occlusal management event

    Time frame: From surgery to the immediate postoperative assessment

    Number of composite perioperative occlusal management event for each patient

Secondary outcomes

  1. Stable intermaxillary fixation

    Time frame: From begining to the end of the surgery

    Number of stable intermaxilary fixation or not for each patient

  2. Surgical revision after surgery

    Time frame: After surgery and the next 6 months

    Number of patient with postoperative complications 6 months after surgery

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Apr 6, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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