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Completed

NCT Number: NCT07622758

Retrospective Study on the Application of Tooth-bone Dual-support Osteotomy/Location Plate in "Surgery-first" Orthognathic Treatment

The goal of this observational study is to learn the accuracy of tooth-bone dual-support osteotomy/location guide plate compared with conventional CAD/CAM interocclusal splints in "surgery-first" orthognathic surgeries.

The main question it aims to answer is:

Does the tooth-bone dual-support osteotomy/location guide plate performed better in accuracy? Does the tooth-bone dual-support osteotomy/location guide plate saved operation time? Participants already underwent orthognathic surgeries.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100144, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age: 18 to 40 years old.
  • Diagnosis: Patients treated at Plastic Surgery Hospital, Chinese Academy of Medical Sciences. Diagnosed with dentofacial deformity upon comprehensive evaluation by two senior attending plastic surgeons.
  • Surgical plan: Scheduled for bimaxillary orthognathic surgery, which may be combined with subapical osteotomy of the maxilla and mandible or genioplasty.
  • Treatment protocol: Cases eligible for the surgery-first approach after joint assessment by craniomaxillofacial surgeons and orthodontists. Orthodontists confirm that satisfactory occlusal relationships can be achieved via postoperative orthodontic treatment. Preoperative requirements are as follows: no or mild anterior crowding, flat or shallow Spee's curve, slight incisor inclination, harmonious maxillary and mandibular dental arches, and at least three stable occlusal contacts in the transitional occlusion.
  • Agreement to follow-up and signed informed consent form.

Exclusion criteria

  • Presence of comorbid diseases or symptoms that may increase surgical risks or compromise surgical outcomes, as determined by two senior plastic surgeons, including but not limited to hypertension, diabetes, immune thrombocytopenic purpura, and hemoglobin (Hb) ≤ 100 g/L.
  • Body dysmorphic disorder, history of psychiatric disorders, or excessively demanding patients with unrealistic expectations.
  • Facial skeletal tumors.
  • Revision surgery after prior orthognathic procedures.

Treatment and study plan

Orthognathic Surgery

Procedure

Orthognathic surgery corrects congenital and acquired dentofacial deformities by surgically repositioning the maxilla, mandible, or chin. It treats severe malocclusion, facial asymmetry, retrognathia, prognathism, and functional issues such as breathing, chewing, and speech difficulties.

Performed in conjunction with orthodontic treatment, the surgery uses pre-surgical planning, interocclusal splints, and cutting guides to achieve accurate bony repositioning and stable internal fixation. It improves both facial aesthetics and stomatognathic function, greatly enhancing patients' quality of life.

Primary outcomes

  1. Accuracy

    Time frame: before and 7 days after the surgery

  2. operation time

    Time frame: the day of surgery

Sponsors and collaborators

Lead sponsor

Peking Union Medical College

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 3, 2026
Registry last updated
Jun 3, 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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