Evaluation Of New Shape of 3D Bone Plate in the Treatment of Posterior Mandibular Fractures
Posterior Mandibular Fractures Involving the Body or Angle Region
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - 60 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 20 Real
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Acerca de la investigación
comparing new design of 3D titanium bone plate with less number of screws with conventional two miniplates in the treatment of posterior mandibular fractures involving the body or angle region
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- Adult patients aged 18 to 60 years old.
- Adult patients of both genders.
- Patients classified as American Society of Anesthesiologists (ASA) physical status I.
- Patients presenting with simple unilateral posterior mandibular fractures involving the mandibular body or angle requiring open reduction and internal fixation.
Exclusion Criteria:
- Pregnant or lactating women.
- ASA II,III,IV
- Patients with associated maxillofacial injuries that may interfere with study outcomes.
- Patients with comminuted mandibular fractures that requires reconstruction plate
- Patients with infected fractures.
- Patients with pathological fractures
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento simple
Pin Buckle (study) group
ten patients with posterior mandibular fractures involving the body or angle region, were treated with pin buckle bone plate
Procedure: ORIF using Pin Buckle bone plate
conventional two miniplates (control) group
ten patients with posterior mandibular fractures involving the body or angle region, were treated with conventional two miniplates
Procedure: ORIF using conventional two miniplates
ORIF using Pin Buckle bone plate PROCEDURE
open reduction and internal fixation
ORIF using conventional two miniplates PROCEDURE
Open Reduction and Internal Fixation
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Change in Radiographic Fracture-Line Width
Plazo: Immediately postoperatively (baseline), 3 months, and 6 months postoperatively.
The width of the fracture line will be measured in millimeters using DIGORA image analysis software on standardized digital panoramic radiographs. Measurements will be performed at three standardized points (superior, middle, and inferior) along the visible fracture line, and the mean value will be calculated. Changes from baseline will be assessed at 3 and 6 months postoperatively and compared between the study and control groups.
Medidas secundarias
Change in Radiographic Bone Density at the Fracture Site
Plazo: Immediately postoperatively (baseline), 3 months, and 6 months postoperatively.
Radiographic bone healing will be assessed by measuring the mean grayscale value at the fracture site using DIGORA image analysis software on standardized digital panoramic radiographs. Measurements will be performed using a standardized region of interest (ROI) at the immediate postoperative baseline, 3 months, and 6 months postoperatively. The change in mean grayscale values from baseline to 3 and 6 months will be evaluated and compared between the study and control groups.
Postoperative Pain Intensity
Plazo: Postoperative days 1, 7, and 14.
Postoperative pain intensity will be evaluated using a 10-cm Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable). Patients will be asked to indicate their pain intensity at each follow-up assessment. Pain scores will be compared between the study and control groups.
Postoperative Facial Edema
Plazo: Preoperatively (baseline) and postoperative days 1, 7, and 14.
Facial edema will be assessed using standardized tape measurements between two anatomical landmarks: the tragus and corner of the mouth, and the lateral canthus and gonion. The sum of the two measurements will be calculated. Changes in the summed measurements relative to the preoperative baseline will be used to evaluate postoperative facial edema and compared between the study and control groups.
Postoperative Wound Healing
Plazo: Postoperative days 1, 7, and 14.
Wound healing will be evaluated clinically using a structured scoring system consisting of five parameters: wound size reduction, tissue appearance, wound exudate, pain and inflammatory response, and mucosal integrity. Each parameter will be scored from 0 (poor) to 2 (good), resulting in a total score ranging from 0 to 10, with higher scores indicating better wound healing. Total wound healing scores will be compared between the study and control groups.
Clinical Stability of Fracture Segments
Plazo: Immediately postoperatively and 6 months postoperatively.
Fracture stability will be assessed by bimanual digital palpation to detect mobility between fracture segments during functional mandibular movements and manual manipulation. Fractures will be classified as stable (absence of detectable movement) or unstable (presence of detectable movement). The proportion of stable fractures will be compared between the study and control groups.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Faculty of Dentistry / Suez Canal UniversityIsmailia, Ismailia Governorate, EgyptEstado desconocido
Equipo y fechas
- Patrocinador principal
- Suez Canal University
- Inicio del estudio
- 18 jul 2025 Real
- Finalización primaria
- 10 mar 2026 Real
- Finalización del estudio
- 10 sept 2026 Real
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Clinical And Radiographic Evaluation Of Pin Buckle Bone Plate in the Treatment of Posterior Mandibular Fractures: A Randomized Study
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026
