- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07651033
3D Titanium Plates for Mandibular Parasymphyseal Fracture Fixation
The Use of 3d Titanium Plates With Two Different Profile Thickness for Open Reduction and Rigid Fixation of Mandibular Parasymphyseal Fracture:Randomised Clinical Trial
Mandibular fractures pose significant challenges in maxillofacial surgery due to their frequency, potential for functional impairment, and aesthetic concerns. Open reduction and internal fixation (ORIF) using titanium plates and screws have revolutionized the management of mandibular fractures.
The advent of 3D printing technology has ushered in a new era of patient-specific implants, offering improved adaptation to individual anatomy and potentially enhancing surgical outcomes.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The face is the window through which we perceive the world around us, and the world noted us. It serves a crucial role in human interaction and injuries to it result in devastating emotional sequelae. The human face constitutes the first contact point in several human interactions, thus injuries and/or mutilation of the facial structures may have a disastrous influence on the affected person.
The facial area is one of the most frequently injured parts of the body, and the mandible is one of the most commonly fractured maxillofacial bones. For the past decades, there has been a significant increase in maxillofacial traumas involving mandible. They are mainly caused by vehicular accidents, sport activities, penetrating injuries, physical assault, work-related accident, metabolic diseases or tumors.
The position, prominence, anatomic configuration, mobility and less bone support of the mandible make it one of the most frequent facial bones to be fractured. The mandibular fracture accounts for 36% to 54% of all fractures in the maxillofacial region. Mandible is the 10th most fractured bone in the whole body. They may occur alone or in combination with other facial bone fractures.
It plays a major role in mastication, speech, and deglutition. Its fractures result in severe loss of function and disfigurement. Fractures through the mandible at the level of the Symphysis and or parasymphysis are relatively common and account for approximately 20% of mandibular fractures. These fractures are often associated with a second fracture of the mandible, especially in the subcondylar region.
Fractures of the symphyseal region are often associated with the clinical findings of a widened intragonial distance with resultant malocclusion. Fractures of the anterior mandible lack two of the stabilizing factors provided to fractures of the posterior tooth-bearing mandible: the splinting effects of the masseter and internal pterygoid muscles, which form a natural sling, and the interlocking cusps and fossae of bicuspid and molar teeth.
Internal fixation in long bones has been adapted with particular modifications for the mandible. The disadvantage with these rigid plates was movement of the fracture fragment while tightening the screws resulting in malocclusion. Also, these plates could only be minimally adapted to the fracture fragments and produced more tension on the bone resulting in loosening of screws. They also require an extraoral approach and are highly technique sensitive.
The introduction of the 3-dimension (3D) system for the treatment of mandibular fractures has offered certain advantages over other plating systems. These plates function as internal fixator, achieving stability by 3D plates. A unique advantage of 3D system is that there is no need to adapt plate over the underlying bone, making plate adaptation easier.
Theoretical advantages proposed include close approximation, greater stability across the fracture site, less precision required in plate adaptation because of the internal/external fixator, less alteration in osseous or occlusal relationship upon screw tightening and, and less time required.
Although several materials can be used for manufacture of small plates, generally titanium is used because of its excellent biocompatibility, resistance to corrosion and pliability. Champy's miniplates require intra oral approach, less technique sensitive and produce consistently good results with regard to occlusion and also avoid the need for intermaxillary fixation
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Giza Governorate
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Cairo, Giza Governorate, Egypten
- Dentistery Hospital, Cairo Universiy
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Age ranging between 20-60 years.
- Patients with mandibular parasymphyseal fractures requiring open reduction and fixation..
- Patients with good health (ASA -I and ASA- II) without any contraindication for surgery or anesthesia.
Exclusion Criteria:
- Patients with pre existing neurological or musculoskeletal disease.
- Patients with infected fractures.
- Patients with simultaneous condylar fracture.
- Patients with regional malignancy.
- Medically compromised patients.
- Patients with blood diseases or severe renal disorders.
- Patients refuse to share in the study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Group A (3d titanium plates of 2 mm):
About 9 patients suffered from Mandibular Parasymphyseal Fracture treated by using 3d titanium plates of 2 mm thickness.
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to compare 3d titanium plates with two different profile thickness for open reduction and rigid fixation of mandibular parasymphyseal fracture.
Andre navne:
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Aktiv komparator: Group B (3d titanium plates of 0.7 mm):
About 9 patients suffered from Mandibular Parasymphyseal Fracture treated by using 3d titanium plates of 0.7 mm thickness.
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to compare 3d titanium plates with two different profile thickness for open reduction and rigid fixation of mandibular parasymphyseal fracture.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Treatment of Postoperative pain
Tidsramme: 48 Hours from the operation
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Treatment of the pain resulted from using 3d titanium plates with two different profile thickness for open reduction and fixation of mandibular Parasymphyseal fracture by using a standardized pain scale.
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48 Hours from the operation
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of postoperative Complications
Tidsramme: from1 week to 6 months
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Secondary outcomes will be evaluated to assess the clinical effectiveness and safety of using 3D titanium plates with different profile thicknesses in the fixation of mandibular body fractures (as infection, malocclusion, and hardwarerelated complications).
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from1 week to 6 months
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Mohamed Atef, Professor, Oral and Maxillofacial Surgery, Faculty of Dentistry, Kasr Al-Aini
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Mandibular Fracture
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med Mandibular Parasymphyseal Fractures
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Alexandria UniversityRekrutteringMandibular rekonstruktion | Mandibular Rekonstruktion* / Metoder | Mandibular resektionEgypten
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Konya Necmettin Erbakan ÜniversitesiAktiv, ikke rekrutterende
-
Ain Shams UniversityAktiv, ikke rekrutterendeMandibular tandlægeEgypten
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Alexandria UniversityAfsluttet
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University Hospital, ToulouseRekrutteringMandibular rekonstruktionFrankrig
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Assiut UniversityIkke rekrutterer endnu
-
Alexandria UniversityAktiv, ikke rekrutterende
-
Alexandria UniversityAfsluttet
-
Cairo UniversityIkke rekrutterer endnuMandibular Symphysis, Block Bone Graft, Mandibular Incisive Canal og CBCT
Kliniske forsøg med 3D Titanium Plates
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The University of Hong KongChinese University of Hong KongAfsluttetKæbeskader | Dentofaciale deformiteter | Mandibulære neoplasmer | Maxillære neoplasmerHong Kong
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Peking University Third HospitalUkendtStor segmentel knogledefektKina
-
Cairo UniversityUkendt
-
Hams Hamed AbdelrahmanAfsluttet
-
Eastern Hepatobiliary Surgery HospitalUkendtHepatocellulært karcinom med CSPHKina
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Cairo UniversityUkendtMinimalt forskudt mandibular vinkelbrud
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Suez Canal UniversitySuez canal university hospitalsIkke rekrutterer endnuKæbe- og ansigtskirurgisk skade | Zygomaticomaxillary Complex Fracture | AnsigtsknoglebrudEgypten
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Cairo UniversityDhamar UniversityAfsluttetForskudt mandibular vinkelbrudEgypten
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Hams Hamed AbdelrahmanAktiv, ikke rekrutterendeOrbital deformitetEgypten
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Sonova AGAfsluttet