Tooth and Bone-borne Cutting/Repositioning Guide and Patient-specific Implant(PSI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorPeking Union Medical College
About this trial
Dentofacial deformity refers to a group of disorders characterized by malocclusion and facial asymmetry resulting from developmental abnormalities of the maxilla and mandible, which cause morphological and positional anomalies of the jaws. Compared with the traditional orthodontics-orthognathic surgery-orthodontics treatment protocol, the surgery-first approach has witnessed a continuous expansion of its clinical application scope. Nevertheless, academic controversies persist regarding its indication boundaries, postoperative jaw stability, and adaptive changes of the temporomandibular joint.
In orthognathic surgery, computer-aided design/computer-aided manufacturing (CAD/CAM) surgical guides indirectly determine the three-dimensional spatial positions of the maxilla and mandible through occlusal relationships. The tooth-bone dual-supported osteotomy and positioning guide combined with pre-bent patient-specific implants (PSIs) forms a novel surgical guide system that enables independent and direct positioning of the maxilla. Theoretically, this system can eliminate errors derived from mandibular positional instability and thereby improve surgical accuracy. However, comparative studies investigating the clinical application of these two types of guides in surgery-first orthognathic surgery are still lacking.
This prospective, randomized, controlled, single-blind clinical study aimed to explore the clinical value of PSIs and conventional CAD/CAM guides in surgery-first orthognathic surgery, with primary outcomes focusing on surgical accuracy, postoperative jaw stability, and temporomandibular joint alterations. The findings will provide evidence-based medical support for the expanded application of this novel technique in precision orthognathic surgery.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ranged from 18 to 40 years old.
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.
Patients were scheduled for bimaxillary orthognathic surgery, with optional adjunctive procedures including maxillary and mandibular subapical osteotomy and genioplasty.
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.
Disqualifiers
Patients who refused to participate in the present study.
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.
Presence of body dysmorphic disorder, a history of psychiatric disorders, or excessively demanding patients with unrealistic treatment expectations.
Presence of facial skeletal tumors.
Trial design
Design model
Parallel
Treatments tested in this trial
bimaxillary surgery(Lefort I and SSRO)
Procedure/SurgeryAll patients underwent surgery-first bimaxillary orthognathic surgery, with concomitant optional procedures including maxillary and mandibular subapical osteotomy and genioplasty.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: PSI groupExperimental treatment 1 intervention
Group B: CAD/CAM groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Linear deviation
Following the superimposition of preoperative virtual surgical planning models and postoperative actual craniomaxillofacial computed tomography (CT) datasets, manual registration was performed based on anatomical landmarks including the nasion, foramen magnum, infraorbital point, zygomatic bone, and zygomatic arch. Linear deviations of the A-point, B-point, canine teeth, and first molars relative to the Frankfort horizontal plane, facial midsagittal plane, and coronal plane were measured and recorded.
Time frame
7 days and 1 yearSecondary outcomes
1
Angular deviation
Following the superimposition of preoperative virtual surgical planning models and postoperative actual craniomaxillofacial computed tomography (CT) datasets, manual registration was performed based on anatomical landmarks including the nasion, foramen magnum, infraorbital point, zygomatic bone, and zygomatic arch. Angular deviations of the A-point, B-point, canine teeth, and first molars relative to the Frankfort horizontal plane, facial midsagittal plane, and coronal plane were measured and recorded.
Time frame
7 days and 1 year2
Soft tissue change
Soft tissue changes were evaluated based on three-dimensional facial scan data acquired using a 3dMD system. Following the superimposition of preoperative virtual surgical planning models and postoperative actual facial scan datasets, changes in soft tissue landmarks were assessed, including the nasal base, lips, nose, etc.
Time frame
1 year3
satisfatory questionnaire
Time frame
1 yearSponsors and contacts
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Peking Union Medical College
Lead sponsor
Beijing Municipal Health Commission
Collaborator
Source ClinicalTrials.gov