Assessment of Condylar Position With Management of Unilateral Mandibular Angle Fracture
Assessment of Condylar Position With Management of Unilateral Mandibular Angle Fracture Using Patient Specific Angle Plate Versus Two Mini Plates (Randomized Clinical Trial)
The objective of this study is to assess condylar position and occlusion after open reduction and internal fixation using two miniplates versus patient specific plate
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Accordingly, this trial will be held using self-positioning specific plate to overcome such problems of the two-point fixation of mini plates : 1. The virtual planning and with aid of plate wings minimize the need for intra-operative IMF during fixation stage.
2.The virtual planning and fabrication of self-seating wings (lips) of the patient-specific plate ensure the seating of the condyle and centric relation.
Finally, the PSP will make fracture the reduction more accurate and will offer a great advantage of reduction of the operative time .
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Giza, Egypten, 12613
- oral and dental medicine Cairo university
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion criteria
1. Patients with a unilateral angle fracture indicated for Open reduction internal Fixation alone or in combination with fracture elsewhere in the mandible.
3. Patients should be free from any systemic disease that may affect normal healing of the bone.
4. Patients with good general condition allowing major surgical procedure under general anesthesia.
5. Patients with physical and psychological tolerance No history of previous surgical intervention in the angle site
Exclusion criteria :
- Patients with high risk systemic diseases like uncontrolled diabetes mellitus. as uncontrolled diabetes mellitus has a negative impact on normal bone healing
- Patients with old and/or mal-union fractures. As they will affect accuracy of reduction of the fractured segments.
- Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: patients treated by two mini plates
patient fixed by 2 mini plates |
patients with mandibular angle fractures fixed by 2 mini plates |
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Eksperimentel: fixation with patient specific plate
the Patient specific plate will make fracture the reduction more accurate and will offer a great advantage of reduction of the operative time |
Angle fracture will be fixed by patient specific plates customized for him |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Assessment of condylar position (Linear displacement)
Tidsramme: 3 months
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Linear displacement (inter condylar distance) with computed tomography in millimeters |
3 months
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Assessment of condylar position (Angular displacement)
Tidsramme: 3 months
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Angular displacement with specialized software in degrees |
3 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
assessment of occlusion
Tidsramme: 3 months
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Assessed by clinical photographs (Binary) |
3 months
|
Samarbejdspartnere og efterforskere
Sponsor
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
Andre undersøgelses-id-numre
- omfs3-3-19
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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