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

3 giugno 2026 aggiornato da: Xiaolei Jin, Peking Union Medical College

A Prospective, Randomized, Controlled, Single-blind Study on the Hybrid Tooth and Bone-supported Cutting and Repositioning Guides Versus Computer-aided Design/Computer-aided Manufactured Splints in "Surgery-first" Orthognathic Surgery

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

50

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Xiaoshuang Guo, M.D.
  • Numero di telefono: +86 13121234163
  • Email: gxsinjnu@126.com

Backup dei contatti dello studio

Luoghi di studio

  • Cina
      • Beijing, Cina
        • Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contatto:
          • Xiaoshuang Guo, M.D.
          • Numero di telefono: +86 13121234163
          • Email: gxsinjnu@126.com

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: PSI group
Tooth-bone borne osteotomy and repositioning guides combined with patient-specific implants constitute the PSI group for short. Preoperative craniomaxillofacial computed tomography (CT) data of patients were imported for three-dimensional reconstruction. Surgical plans, including genioplasty procedures, were collaboratively formulated by surgeons and orthodontists with full consideration of patients' personal preferences. Custom tooth-bone dual-supported osteotomy and positioning guides for both the maxilla and mandible were digitally designed and subsequently fabricated. A partial skull model was printed preoperatively, on which custom titanium plates were pre-bent in advance in strict accordance with the established surgical protocol.
Procedura: 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.
Comparatore attivo: CAD/CAM group
Patients' preoperative craniomaxillofacial computed tomography (CT) data were imported for three-dimensional (3D) reconstruction. Surgeons and orthodontists collaboratively formulated individualized surgical plans based on patients' preferences, including genioplasty procedures, followed by the design and fabrication of CAD/CAM intermediate and final surgical guides.
Procedura: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Linear deviation
Lasso di tempo: 7 days and 1 year
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.
7 days and 1 year

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Angular deviation
Lasso di tempo: 7 days and 1 year
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.
7 days and 1 year
Soft tissue change
Lasso di tempo: 1 year
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.
1 year
satisfatory questionnaire
Lasso di tempo: 1 year
1 year

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Peking Union Medical College

Collaboratori

Beijing Municipal Health Commission

Investigatori

  • Direttore dello studio: Guodong Song, Chinese Academy of Medical Sciences, Peking Union Medical College, Plastic Surgery Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

8 giugno 2026

Completamento primario (Stimato)

8 giugno 2028

Completamento dello studio (Stimato)

31 dicembre 2028

Date di iscrizione allo studio

Primo inviato

28 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 giugno 2026

Primo Inserito (Effettivo)

8 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 2026-4-4043

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Raw data of linear/angular deviation, soft tissue change, and questionnaire

Periodo di condivisione IPD

Date of public release: The day of online publication of the article (expected December 2029)

Criteri di accesso alla condivisione IPD

The raw data will be published as supplementary materials alongside the full text on the official platform of the target journal, and available for free download and access by readers.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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