Tooth-and-bone–guided, patient-specific implant for surgery-first jaw realignment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study explores a novel CAD/CAM surgical guide system that uses tooth and bone support to position the maxilla and mandible for bimaxillary orthognathic surgery. It combines a tooth–bone dual-supported osteotomy and positioning guide with pre-bent patient-specific implants to guide jaw realignment. Participants are adults with dentofacial deformity undergoing a surgery-first treatment plan, and eligibility includes planned Lefort I and SSRO with potential adjunctive procedures. The approach aims to improve occlusal outcomes and jaw stability in the postoperative period, though it addresses ongoing questions about indications and TMJ adaptation. The study is conducted at a major Chinese medical institution with involvement from national and regional collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ranged from 18 to 40 years old.
2. Patients were diagnosed with dentofacial deformity and received treatment at the Plastic Surgery Hospital, Chinese Academy of Medical Sciences. The diagnosis was confirmed via comprehensive evaluation by two senior attending plastic surgeons.
3. Patients were scheduled for bimaxillary orthognathic surgery, with optional adjunctive procedures including maxillary and mandibular subapical osteotomy and genioplasty.
4. Patients were indicated for the surgery-first approach based on joint assessment by craniomaxillofacial surgeons and orthodontists. Orthodontists confirmed that satisfactory occlusal relationships could be achieved through postoperative orthodontic treatment. Preoperative dental conditions met the following requirements: no or mild anterior dental crowding, flat or shallow Spee's curve, slight incisor inclination, harmonious maxillary and mandibular dental arches, and at least three stable occlusal contacts under transitional occlusion.
5. Patients agreed to complete follow-up examinations and provided signed informed consent.

Exclusion Criteria:

1. Patients who refused to participate in the present study.
2. Presence of comorbidities that may increase surgical risks or impair surgical outcomes, as assessed by two senior plastic surgeons, including but not limited to hypertension, diabetes, immune thrombocytopenic purpura, and hemoglobin (Hb) level ≤ 100 g/L.
3. Presence of body dysmorphic disorder, a history of psychiatric disorders, or excessively demanding patients with unrealistic treatment expectations.
4. Presence of facial skeletal tumors.
5. Patients who required revision surgery after previous orthognathic procedures.
6. Cases judged unable to achieve stable occlusal relationships through postoperative orthodontic treatment following joint evaluation by craniomaxillofacial surgeons and orthodontists, including patients with severe dental crowding, maxillomandibular arch width discrepancy, temporomandibular joint disorders, or periodontal diseases.

Where it's running

• Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  Beijing, China Recruiting

Study contacts

• Study coordinator: Xiaoshuang Guo, M.D.
• Email: gxsinjnu@126.com
• Phone: +86 13121234163

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Hilotherapy versus Kinesio taping for recovery after bimaxillary jaw surgery

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.