- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07595978
Soft Tissue Changes After Orthognathic Surgery (Orthognathic)
Three-Dimensional Stereophotogrammetric Analysis of Soft Tissue Changes Following Minimally Invasive Versus Conventional Orthognathic Surgery in Skeletal Class III Patients
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Kayseri
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Kayseri, Kayseri, Tyrkiet (Türkiye), 38000
- Erciyes University Faculty of Dentistry Department of Orthodontics
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
Skeletal Class III patients requiring bimaxillary orthognathic surgery Patients treated with minimally invasive or conventional orthognathic surgery Availability of high-resolution three-dimensional stereophotogrammetric images obtained preoperatively and at least 6 months postoperatively Patients with complete clinical records Completion of craniofacial growth Patients with less than 10 mm maxillary advancement/setback
Exclusion Criteria:
Craniofacial syndromes or congenital anomalies History of previous orthognathic surgery Facial trauma affecting soft tissue morphology Incomplete clinical or imaging records Systemic diseases affecting soft tissue healing or craniofacial morphology
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Minimally Invasive Orthognathic Surgery
Skeletal Class III patients treated with minimally invasive bimaxillary orthognathic surgery characterized by reduced soft tissue dissection, limited surgical exposure, and preservation of vascular integrity compared with the conventional approach.
This technique aims to minimize postoperative soft tissue alterations and improve postoperative recovery.
Soft tissue changes were evaluated using three-dimensional stereophotogrammetric analysis.
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Bimaxillary orthognathic surgery performed using a minimally invasive surgical approach characterized by limited soft tissue dissection, reduced surgical exposure, and preservation of vascular integrity to minimize postoperative soft tissue alterations.
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Aktiv komparator: Conventional Orthognathic Surgery
Skeletal Class III patients treated with conventional bimaxillary orthognathic surgery.
Postoperative soft tissue changes were evaluated using three-dimensional stereophotogrammetric analysis.
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Bimaxillary orthognathic surgery performed using conventional surgical exposure and standard soft tissue dissection techniques.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Three-Dimensional Soft Tissue Landmark Displacements
Tidsramme: Up to 6 months
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Three-dimensional soft tissue landmark displacements (mm) evaluated using stereophotogrammetric analysis in skeletal Class III patients undergoing minimally invasive and conventional bimaxillary orthognathic surgery.
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Up to 6 months
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Linear Soft Tissue Measurements
Tidsramme: Up to 6 months
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Linear soft tissue measurements (mm) evaluated using stereophotogrammetric analysis in skeletal Class III patients undergoing minimally invasive and conventional bimaxillary orthognathic surgery.
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Up to 6 months
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Angular Soft Tissue Measurements
Tidsramme: Up to 6 months
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Angular soft tissue measurements (degree) evaluated using stereophotogrammetric analysis in skeletal Class III patients undergoing minimally invasive and conventional bimaxillary orthognathic surgery.
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Up to 6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Airway Measurements
Tidsramme: Up to 6 months
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Airway measurements (mm) evaluated using cephalometric analysis in skeletal Class III patients undergoing minimally invasive and conventional bimaxillary orthognathic surgery.
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Up to 6 months
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Lip Thickness Measurements
Tidsramme: Up to 6 months
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Upper and lower lip thickness measurements (mm) evaluated using three-dimensional stereophotogrammetric analysis in skeletal Class III patients undergoing minimally invasive and conventional bimaxillary orthognathic surgery.
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Up to 6 months
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: GOKHAN COBAN, Associate Professor, Erciyes University Faculty of Dentistry
Publikationer og nyttige links
Generelle publikationer
- Weinberg SM. 3D stereophotogrammetry versus traditional craniofacial anthropometry: Comparing measurements from the 3D facial norms database to Farkas's North American norms. Am J Orthod Dentofacial Orthop. 2019 May;155(5):693-701. doi: 10.1016/j.ajodo.2018.06.018.
- Dinu C, Manea A, Tomoiaga D, Baciut M, Almasan O, Mitre AO, Barbur I, Hedesiu M, Armencea G, Opris H, Stoia S, Tamas T, Baciut G, Onisor F, Bran S. Recovery following Orthognathic Surgery Procedures-A Pilot Study. Int J Environ Res Public Health. 2022 Nov 30;19(23):16028. doi: 10.3390/ijerph192316028.
- Ajmera DH, Singh P, Leung YY, Gu M. Three-dimensional evaluation of soft-tissue response to osseous movement after orthognathic surgery in patients with facial asymmetry: A systematic review. J Craniomaxillofac Surg. 2021 Sep;49(9):763-774. doi: 10.1016/j.jcms.2021.04.010. Epub 2021 Apr 24.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- TDH-2024/305
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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