NCT07826416尚未招募不适用
"Comparative Assessment of Interfragmentary Bone Density in Anterior Mandibular Fracture Fixation Using Second Generation Herbert Screws Versus 3-Dimensional Miniplates: A Randomized Clinical Trial"
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 22
- 主要终点
- Interfragmentary Bone Density
研究概览
简要总结
the goal of this clinical trial is to compare two methods of fixing fractures in the front part of the jaw (mandible): second-generation Herbert screws and 3-dimensional miniplates.
Importance:
Choosing the right fixation method is crucial for proper bone healing after a jaw fracture.
Participants:
Patients with recent anterior mandibular fractures requiring surgery.
Key Findings:
The study assessed which method better maintained bone density around the fracture, indicating potential benefits for healing.
Implications:
Understanding the effectiveness of these methods aids healthcare providers in making informed decisions, ultimately improving patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- ••Adult patients aged 18 years or older, irrespective of gender.
- •Anterior mandibular fractures indicated for open reduction and internal fixation (inter-foraminal).
- •Dentate/partially dentate patients.
排除标准
- ••Medically compromised patients contradicting operation (ASA III, IV & V).
- •Comminuted fractures.
- •Completely edentulous patients.
研究组 & 干预措施
interventional group
Experimental
干预措施: headless compression screw (Device)
comparator group
Active Comparator
干预措施: 3D mini plates (Device)
结局指标
主要结局
Interfragmentary Bone Density
时间窗: Immediately postoperative (within one week) and after 3 months
次要结局
未报告次要终点
研究者
Dina Abd El Aziz Metwally
PHD candidate
Cairo University
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AI-Based Medical Image Analysis Software using X-ray Imaging.Other early complications of trauma, (2) ICD-10 Condition: S920||Fracture of calcaneus, (3) ICD-10 Condition: S921||Fracture of talus, (4) ICD-10 Condition: S923||Fracture of metatarsal bone(s), (5) ICD-10 Condition: S924||Fracture of great toe, (6) ICD-10 Condition: S925||Fracture of lesser toe(s), (7) ICD-10 Condition: S928||Other fracture of foot, except ankle, (8) ICD-10 Condition: S820||Fracture of patella, (9) ICD-10 Condition: S821||Fracture of upper end of tibia, (10) ICD-10 Condition: S822||Fracture of shaft of tibia, (11) ICD-10 Condition: S823||Fracture of lower end of tibia, (12) ICD-10 Condition: S824||Fracture of shaft of fibula, (13) ICD-10 Condition: S825||Fracture of medial malleolus, (14) ICD-10 Condition: S826||Fracture of lateral malleolus, (15) ICD-10 Condition: S828||Other fractures of lower leg, (16) ICD-10 Condition: S720||Fracture of head and neck of femur, (17) ICD-10 Condition: S721||Pertrochanteric fracture, (18) ICD-10 Condition: S722||Subtrochanteric fracture of femur, (19) ICD-10 Condition: S723||Fracture of shaft of femur, (20) ICD-10 Condition: S724||Fracture of lower end of femur, (21) ICD-10 Condition: S728||Other fracture of femur, (22) ICD-10 Condition: S620||Fracture of navicular [scaphoid] bone of wrist, (23) ICD-10 Condition: S621||Fracture of other and unspecifiedcarpal bone(s), (24) ICD-10 Condition: S622||Fracture of first metacarpal bone, (25) ICD-10 Condition: S623||Fracture of other and unspecifiedmetacarpal bone, (26) ICD-10 Condition: S625||Fracture of thumb, (27) ICD-10 Condition: S626||Fracture of other and unspecifiedfinger(s), (28) ICD-10 Condition: S520||Fracture of upper end of ulna, (29) ICD-10 Condition: S521||Fracture of upper end of radius, (30) ICD-10 Condition: S522||Fracture of shaft of ulna, (31) ICD-10 Condition: S523||Fracture of shaft of radius, (32) ICD-10 Condition: S525||Fracture of lower end of radius, (33) ICD-10 Condition: S526||Fracture of lower end of ulna, (34) ICD-10 Condition: S420||Fracture of clavicle, (35) ICD-10 Condition: S421||Fracture of scapula, (36) ICD-10 Condition: S422||Fracture of upper end of humerus, (37) ICD-10 Condition: S422||Fracture of upper end of humerus, (38) ICD-10 Condition: S423||Fracture of shaft of humerus, (39) ICD-10 Condition: S424||Fracture of lower end of humerus, (40) ICD-10 Condition: S429||Fracture of shoulder girdle, partunspecified, (41) ICD-10 Condition: S490||Physeal fracture of upper end of humerus, (42) ICD-10 Condition: S491||Physeal fracture of lower end of humerus, (43) ICD-10 Condition: S498||Other specified injuries of shoulder and upper arm, (44) ICD-10 Condition: S590||Physeal fracture of lower end of ulna, (45) ICD-10 Condition: S591||Physeal fracture of upper end of radius, (46) ICD-10 Condition: S592||Physeal fracture of lower end of radius, (47) ICD-10 Condition: S598||Other specified injuries of elbowand forearm, (48) ICD-10 Condition: S698||Other specified injuries of wrist,hand and finger(s), (49) ICD-10 Condition: S790||Physeal fracture of upper end of femur, (50) ICD-10 Condition: S791||Physeal fracture of lower end of femur, (51) ICD-10 Condition: S798||Other specified injuries of hip and thigh, (52) ICD-10 Condition: S890||Physeal fracture of upper end of tibia, (53) ICD-10 Condition: S891||Physeal fracture of lower end of tibia, (54) ICD-10 Condition: S892||Physeal fracture of upper end of fibula, (55) ICD-10 Condition: S893||Physeal fracture of lower end of fibula, (56) ICD-10 Condition: S898||Other specified injuries of lowerleg, (57) ICD-10 Condition: S990||Physeal fracture of calcaneus, (58) ICD-10 Condition: S991||Physeal fracture of metatarsal, (59) ICD-10 Condition: S992||Physeal fracture of phalanx of toe, (60) ICD-10 Condition: S998||Other specified injuries of ankleand foot, (61) ICD-10 Condition: S390||Injury of muscle, fascia and tendon of abdomen, lower back and pelvis, (62) ICD-10 Condition: S320||Fracture of lumbar vertebra, (63) ICD-10 Condition: S321||Fracture of sacrum, (64) ICD-10 Condition: S322||Fracture of coccyx, (65) ICD-10 Condition: S323||Fracture of ilium, (66) ICD-10 Condition: S324||Fracture of acetabulum, (67) ICD-10 Condition: S325||Fracture of pubis, (68) ICD-10 Condition: S326||Fracture of ischium, (69) ICD-10 Condition: S328||Fracture of other parts of pelvis, (70) ICD-10 Condition: S220||Fracture of thoracic vertebra, (71) ICD-10 Condition: S222||Fracture of sternum, (72) ICD-10 Condition: S223||Fracture of one rib, (73) ICD-10 Condition: S224||Multiple fractures of ribs, (74) ICD-10 Condition: S298||Other specified injuries of thorax, (75) ICD-10 Condition: S120||Fracture of first cervical vertebra, (76) ICD-10 Condition: S121||Fracture of second cervical vertebra, (77) ICD-10 Condition: S122||Fracture of third cervical vertebra, (78) ICD-10 Condition: S123||Fracture of fourth cervical vertebra, (79) ICD-10 Condition: S124||Fracture of fifth cervical vertebra, (80) ICD-10 Condition: S125||Fracture of sixth cervical vertebra, (81) ICD-10 Condition: S126||Fracture of seventh cervical vertebra, (82) ICD-10 Condition: S128||Fracture of other parts of neck, (83) ICD-10 Condition: S198||Other specified injuries of neck, (84) ICD-10 Condition: S020||Fracture of vault of skull, (85) ICD-10 Condition: S021||Fracture of base of skull, (86) ICD-10 Condition: S022||Fracture of nasal bones, (87) ICD-10 Condition: S023||Fracture of orbital floor, (88) ICD-10 Condition: S024||Fracture of malar, maxillary and zygoma bones, (89) ICD-10 Condition: S026||Fracture of mandible, (90) ICD-10 Condition: S028||Fractures of other specified skulland facial bones, (91) ICD-10 Condition: S098||Other specified injuries of head,CTRI/2026/01/100865Nuvo AI Pvt. Ltd100,000
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COMPARATIVE EVALUATION OF THE MODIFIED ARCH BAR AND CONVENTIONAL ERICH ARCH BAR FOR MAXILLOMANDIBULAR FIXATION IN MANDIBULAR FRACTURES.CTRI/2025/03/082869DR YOGENDRA SINGH THAKUR30