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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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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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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 3D plates
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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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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change in maximum mouth opening
Tidsram: 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
Tidsram: 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
Tidsram: up to 12 weeks
|
patient was asked about prescence of sensation alteration |
up to 12 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
change in Inter-fragmentary Mobility
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1058-04/2025
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