Modified 3d Rectangular Grid Plate for Fixation of Anterior and Body Mandibular Fractures
Evaluation of the Use of Modified 3d Rectangular Grid Plate for Fixation of Anterior and Body Mandibular Fractures (Randomized Controlled Clinical Trial)
Background: Fractures of anterior mandible (symphysis and parasymphysis) make up about 9% to 57%, of mandibular fractures, and body fractures make up about 21%; posing challenges for stabilization due to anatomical constraints. Traditional 3D plates have limitations in this area, leading to the development of Modified 3D Rectangular Grid plates. Studies have shown that these plates offer superior stabilization over larger configurations while maintaining a low profile like miniplates. Additionally, design modifications ensure mental nerve preservation, balancing effective fixation with neurovascular safety.
Aim of this study: To evaluate the use of Modified 3D Rectangular Grid plates in comparison with conventional mini plates for fixation of mandibular fracture in the anterior and body regions, clinically regarding pain, interfragmentary mobility, maximal inter-incisal opening, wound healing, and sensory nerve evaluation, and radiographically regrading fracture reduction.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
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Azarita
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Alexandria, Azarita, Egypten, 00203
- Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
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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:
- Patients suffering from recent fractures at the symphysis, parasymphysis and body regions
- Adult patients with no gender predilection who agreed to present for follow-up visits
- A fracture that demands open reduction and internal fixation.
- The patient is medically fit for general anesthesia
Exclusion Criteria:
- ASA classification IV, V, VI
- Existence of infection at the fracture line
- Pathological fracture
- An old fracture
- Completely edentulous patient
- Patients with a comminuted fracture
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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Eksperimentel: 3D plates
|
The system consists of a lower 1.5-mm rectangular plate and an upper linear plate that interlock through circular recesses and elevations. Each component is 0.75 mm thick at the junction, giving a total thickness of 1.5 mm. After screw fixation, it provides 3D stability similar to standard 3D plates while minimizing risk to the mental nerve. |
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Aktiv komparator: Conventional plates
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conventional mini plates for fixation of mandibular fracture in the anterior and body regions |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
change in maximum mouth opening
Tidsramme: up to 12 weeks
|
Using a millimetre ruler to measure maximal inter-incisal mouth opening; considered to be adequate if >30 mm and inadequate if <30 mm |
up to 12 weeks
|
|
change in pain scores
Tidsramme: up to 12 weeks
|
Will be assessed through a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe |
up to 12 weeks
|
|
change in Neurosensory function
Tidsramme: up to 12 weeks
|
patient was asked about prescence of sensation alteration |
up to 12 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
change in Inter-fragmentary Mobility
Tidsramme: up to 12 weeks
|
The mobility will be assessed by bi-manual palpation across the fracture site. |
up to 12 weeks
|
|
change in Wound Evaluation
Tidsramme: up to12 weeks
|
The sutured wounds will be examined for signs and symptoms of infection uisng modified Landry's index |
up to12 weeks
|
|
adequacy of fracture line reduction
Tidsramme: 12 weeks
|
Whenever alignment of the inferior border of the mandible will be maintained across the fracture line, it will be considered an excellent reduction. If a discrepancy of 1-3 mm will be noted, it will be considered a good reduction. If a discrepancy of 3-5 mm will be noted, it will be labeled as a fair reduction. If the discrepancy will be > 5 mm, it will be considered a poor reduction. |
12 weeks
|
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1058-04/2025
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