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

3. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

50

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Xiaoshuang Guo, M.D.
  • Telefonnummer: +86 13121234163
  • E-Mail: gxsinjnu@126.com

Studieren Sie die Kontaktsicherung

Studienorte

  • China
      • Beijing, China
        • Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verfahren: 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.
Aktiver Komparator: 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.
Verfahren: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Linear deviation
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Angular deviation
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 1 year
1 year

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Peking Union Medical College

Mitarbeiter

Beijing Municipal Health Commission

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

8. Juni 2026

Primärer Abschluss (Geschätzt)

8. Juni 2028

Studienabschluss (Geschätzt)

31. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

28. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. Juni 2026

Zuerst gepostet (Tatsächlich)

8. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 2026-4-4043

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

IPD-Sharing-Zeitrahmen

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

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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