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3D Titanium Plates for Mandibular Body Fracture Fixation

11 juni 2026 uppdaterad av: haitham Aldebass, Cairo University

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.

Studieöversikt

Status

Avslutad

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

18

Fas

  • Inte tillämpbar

Kontakter och platser

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

Studieorter

    • Giza Governorate
      • Cairo, Giza Governorate, Egypten
        • Dentistery Hospital, Cairo Universiy

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

Beskrivning

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

Studieplan

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

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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.
to compare the 3D titanium plates with two different profile thickness for open reduction and fixation of mandibular body fracture.
Andra namn:
  • Open Reduction and Rigid Internal Fixation
Aktiv komparator: 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.
to compare the 3D titanium plates with two different profile thickness for open reduction and fixation of mandibular body fracture.
Andra namn:
  • Open Reduction and Rigid Internal Fixation

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Treatment of Postoperative pain
Tidsram: 48 Hours from the operation
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.
48 Hours from the operation

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of postoperative Complications
Tidsram: from1 week to 6 months
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).
from1 week to 6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Studiestol: Mohamed Atef, Professor, of Oral and Maxillofacial Surgery, Faculty of Dentistry - Kasr Al-Aini

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)

15 december 2024

Primärt slutförande (Faktisk)

15 december 2025

Avslutad studie (Faktisk)

15 februari 2026

Studieregistreringsdatum

Först inskickad

11 juni 2026

Först inskickad som uppfyllde QC-kriterierna

11 juni 2026

Första postat (Faktisk)

16 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

16 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 juni 2026

Senast verifierad

1 februari 2025

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • Mandibular Fracture Fixation

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Ja

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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