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Retrospective Study on the Application of Tooth-bone Dual-support Osteotomy/Location Plate in "Surgery-first" Orthognathic Treatment

28 maj 2026 uppdaterad av: Xiaolei Jin, Peking Union Medical College

The goal of this observational study is to learn the accuracy of tooth-bone dual-support osteotomy/location guide plate compared with conventional CAD/CAM interocclusal splints in "surgery-first" orthognathic surgeries.

The main question it aims to answer is:

Does the tooth-bone dual-support osteotomy/location guide plate performed better in accuracy? Does the tooth-bone dual-support osteotomy/location guide plate saved operation time? Participants already underwent orthognathic surgeries.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Faktisk)

20

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100144
        • Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Ja

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
tooth-bone dual support cutting/repositioning guide
This tooth-bone dual support cutting/repositioning guide is a custom surgical template used in orthognathic surgery. It integrates both tooth-borne and bone-borne fixation for high stability. It accurately defines osteotomy lines and repositioning paths, improves surgical precision, reduces intraoperative error, and enhances postoperative occlusion and facial symmetry.

Orthognathic surgery corrects congenital and acquired dentofacial deformities by surgically repositioning the maxilla, mandible, or chin. It treats severe malocclusion, facial asymmetry, retrognathia, prognathism, and functional issues such as breathing, chewing, and speech difficulties.

Performed in conjunction with orthodontic treatment, the surgery uses pre-surgical planning, interocclusal splints, and cutting guides to achieve accurate bony repositioning and stable internal fixation. It improves both facial aesthetics and stomatognathic function, greatly enhancing patients' quality of life.

interocclusal splint
An interocclusal splint is a custom-made acrylic appliance widely used in orthognathic surgery. It establishes stable, reproducible maxillomandibular relationship, guides precise repositioning of jaws, maintains planned occlusion intraoperatively, and improves surgical accuracy and postoperative stability.

Orthognathic surgery corrects congenital and acquired dentofacial deformities by surgically repositioning the maxilla, mandible, or chin. It treats severe malocclusion, facial asymmetry, retrognathia, prognathism, and functional issues such as breathing, chewing, and speech difficulties.

Performed in conjunction with orthodontic treatment, the surgery uses pre-surgical planning, interocclusal splints, and cutting guides to achieve accurate bony repositioning and stable internal fixation. It improves both facial aesthetics and stomatognathic function, greatly enhancing patients' quality of life.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
drifttid
Tidsram: operationsdagen
operationsdagen
Accuracy
Tidsram: before and 7 days after the surgery
before and 7 days after the surgery

Samarbetspartners och utredare

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 februari 2024

Primärt slutförande (Faktisk)

1 maj 2026

Avslutad studie (Faktisk)

25 maj 2026

Studieregistreringsdatum

Först inskickad

28 maj 2026

Först inskickad som uppfyllde QC-kriterierna

28 maj 2026

Första postat (Faktisk)

3 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2026(085)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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