New study to test which surgical guide works best for jaw realignment
NCT ID NCT07634276
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times
Summary
This study compares two methods for guiding jaw surgery: traditional computer-designed splints versus a newer guide system that attaches to both teeth and bone. The goal is to see which method is more accurate and leads to better stability after surgery. About 50 adults with jaw deformities will take part, and researchers will measure how well the jaw bones heal and align.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 40 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
RECRUITINGBeijing, 100144, China
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Other studies related to the condition(s) this trial covers.
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- Jaw surgery showdown: custom implants vs. traditional splints