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3D Titanium Plates for Mandibular Body Fracture Fixation
The Use of 3d Titanium Plates With Two Different Profile Thickness for Open Reduction and Rigid Fixation of Mandibular Body Fracture : Randomised Clinical Trial
Mandibular body fracture 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.
Recent advancements in technology have led to the development of patient-specific 3D titanium implants, offering the potential for improved anatomical fit and stability. Moreover, the concept of low-profile implants has gained traction, aiming to minimize soft tissue irritation and enhance patient comfort postoperatively.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Facial trauma is common in road traffic accidents (RTA). Due to modernization, increased number of vehicles and failure to follow traffic rules are among various causes of facial trauma. Mandible is one of the frequently fractured bones in RTA. It has been observed that the most common sites of mandibular fracture are angle, body, and ramus.
The incidence of mandibular fracture ranges between 40% and 65% of all facial fractures and so are twice as common as fractures of the midfacial bones. Fractures of the angle of mandible can present with long term disabling sequelae and make up 23%-42% of all fractures in the mandible.
Other than traumatic injuries of the face, there are several factors leading to mandibular body fracture as direct impact or blunt force trauma, indirect trauma to the chin or side of the face, facial fractures, osteoporosis, tumors or cysts in the jawbone, some dental procedures, elderly population, and occupational hazards.
Long term sequel of untreated or poorly treated fractures includes various impairments such as functional, aesthetic, neurological and psychological. The main goal in the treatment of bone fracture is to predictably restore its preinjury anatomical form, with associated aesthetics and function. Techniques for treatment of mandibular fracture have evolved significantly in past decades. These techniques have ranged from closed reduction with maxillomandibular fixation, open reduction with wire osteosynthesis, to open reduction with either rigid internal fixation or adaptive miniplate fixation.
They are best managed by placing one single plate in neutral zone that is sub-apically along with arch bar as tension band. However, in case of severely displaced fractures, inadequate dentition or presence of associated fractures, there are changes in biomechanical vector of forces, which demands for rigid fixation like two plates or load-bearing fixation.
Monocortical plates stabilize the fracture two-dimensionally which can be inadequate fixation in the above-mentioned situations especially in load-bearing area that has led to development of 3D plates. 3D plates are quadrangular in geometry providing stability three-dimensionally due to its design and compact form which counteract against the torsional forces especially in intermental foramen region.
Open reduction and internal fixation (ORIF) using titanium plates and screws have become the standard of care for stabilizing displaced mandibular body fracture, facilitating proper alignment, and promoting optimal healing. However, the optimal design and thickness of these implants remain subjects of debate among maxillofacial surgeons.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Giza Governorate
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Cairo, Giza Governorate, Egypte
- Dentistery Hospital, Cairo Universiy
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion criteria:
- Age ranging between 20-60 years.
- Patients with mandibular body 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Group A (3d titanium plates of 2 mm):
About 9 patients suffered from mandibular fracture treated by using 3d titanium plates of 2 mm thickness.
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to compare the 3D titanium plates with two different profile thickness for open reduction and fixation of mandibular body fracture.
Andere namen:
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Actieve vergelijker: Group B (3d titanium plates of 0.7 mm):
About 9 patients suffered from mandibular fracture treated by using 3d titanium plates of 0.7 mm thickness.
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to compare the 3D titanium plates with two different profile thickness for open reduction and fixation of mandibular body fracture.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Treatment of Postoperative pain
Tijdsspanne: 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 body fracture by using a standardized pain scale.
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48 Hours from the operation
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Incidence of postoperative Complications
Tijdsspanne: 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 hardware-related complications).
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from1 week to 6 months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Mohamed Atef, Professor, of Oral and Maxillofacial Surgery, Faculty of Dentistry - Kasr Al-Aini
Studie record data
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Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Mandibular Fracture Fixation
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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