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Tooth and Bone-borne Cutting/Repositioning Guide and Patient-specific Implant(PSI)

NCT07634276 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-09-02

No results posted yet for this study

Summary

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.

Conditions

  • CAD/CAM
  • Patient Specific Implant
  • Orthognathic Surgery
  • Surgery-first

Interventions

PROCEDURE

bimaxillary surgery(Lefort I and SSRO)

All patients underwent surgery-first bimaxillary orthognathic surgery, with concomitant optional procedures including maxillary and mandibular subapical osteotomy and genioplasty.

Sponsors & Collaborators

  • Beijing Municipal Health Commission

    collaborator OTHER_GOV

  • Peking Union Medical College

    lead OTHER

Principal Investigators

  • Guodong Song · Chinese Academy of Medical Sciences, Peking Union Medical College, Plastic Surgery Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-03
Primary Completion
2028-06-08
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07634276 on ClinicalTrials.gov