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New Tooth-Bone plate may speed up jaw surgery and improve accuracy

NCT ID NCT07622758

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at 20 patients who had jaw surgery to correct facial deformities. Researchers compared a new tooth-bone dual-support guide plate to the usual CAD/CAM splints to see which was more accurate and faster. The goal was to find out if the new plate could improve surgery results and save time in the operating room.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If the new plate proves more accurate and faster, it could improve surgical outcomes and reduce time in the operating room for jaw correction surgeries.
What could go wrong
This is a small, retrospective study with only 20 participants, so results may not apply to all patients. It does not test a new drug or treatment, only a surgical tool.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

20 people

The number who actually took part.

Started

Feb 2024

Finished

May 2026

Lead sponsor

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.

Who is studied

Patients primarily diagnosed as "dentofacial deformities" who are scheduled for "surgery-first" bimaxillary orthognathic surgery. They are 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.

Ages

18 to 40 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

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: 18 to 40 years old. 2. 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. 3. Surgical plan: Scheduled for bimaxillary orthognathic surgery, which may be combined with subapical osteotomy of the maxilla and mandible or genioplasty. 4. 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. 5. Agreement to follow-up and signed informed consent form. Exclusion Criteria: 1. 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. 2. Body dysmorphic disorder, history of psychiatric disorders, or excessively demanding patients with unrealistic expectations. 3. Facial skeletal tumors. 4. Revision surgery after prior orthognathic procedures.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

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

    Beijing, Beijing Municipality, 100144, China

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