comparative study between three dimensional Z plates and two conventional miniplates for the internal fixation of mandibular parasymphysis fracture
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To access the fracture stability i.e. to observe any deviation occur from intraoperatively achieved reduction and occlusion, effects on bite force using gnathodynamometer, intraoperative time and occlusion.
研究概览
简要总结
Objective
The objective of this study are -
To access the fracture stability i.e. to observe any deviation occur from intraoperatively achieved reduction and occlusion.
To find the effects on bite force using gnathodynamometer.
To find effect of Z plates on intraoperative time and occlusion.
To find effect of Z plates on paraesthesia and infection.
To find any postoperative complications like malunion, delayed union,
Nonunion etc
Methodology
The patients will be randomly divided into two equal groups:
Group I in which newly designed Z-shaped miniplates will be used for fixation of mandibular symphyseal and parasymphyseal region fractures.
Group II in which two straight miniplates will be used for fixation of mandibular symphyseal and parasymphyseal region fractures.
Interventions****Armamentarium:
Plating kit
Z Plate
6mm and 8mm screws (2mm system)
Emergency screws (if required)
1.5 mm diameter drill bits
Self-holding screw driver
Ordinary screw driver
Plate holder
Plate bender
Plate cutter
General surgical instruments
Diagnostics-probe, mouth mirror and tweezer
BP Handle and Blade
Periosteal elevator
Howarth’s elevator
Artery forceps
Dissector
Langenbeck retractors
Malleable retractors
Adson’s tissue holding forceps-toothed and non-toothed forceps
Kocher
Mouth prop
Hister’s mouth opener
Notched ramus retractors
Tongue depressor
Metallic scale
Trimmers
Chisel and mallet
Micromotor Set and Straight Handpiece
Surgical burs
10ml Syringe
Bone curette
Bone file
Needle holder
Dean’s scissors
3-0 Vicryl suture
4-0 Prolene suture
Erich arch bar
24gauge wire
Wire twister
Wire cutter
Bite Force recorder (Gnathodynamometer)
Surgical procedure:
Patient will be laid on OT table and intravenous (IV) line will be secured. General anaesthesia will be induced by propofol and nasotracheal intubation will be done and anaesthesia will be maintained by Halothane, N2O and O2. The extraoral part preparation will be done using Savlon and Betadine followed by draping and intraoral part preparation using betadine. Erich Arch bar will be adapted in maxillary and mandibular arch and secured by 24 Gauge Stainless steel wires. Occlusion will be achieved by intermaxillary fixation. Vestibular/Degloving incision will be made to expose the fracture site. After exposure of the fracture site, anatomic reduction will be achieved followed by fixation using 2mm Z plate at lower border of mandible. In Group 1 patients, in which 2 mm Z plate will be placed at lower border of mandible secured with 8mm and 6 mm screws. In Group 2 patients, Two conventional 4-hole non-compression titanium miniplate will be adapted at the superior and inferior borders of fracture using 6mm and 8mm screws. Irrigation of surgical field using saline will be performed. After the haemostasis is achieved, the suturing will be done in two layers. The deep muscular layer will be closed followed by the suturing of mucosal layers using 3-0 polygalactin sutures. Patients will be prescribed antibiotics and analgesics postoperatively for 5 days. Patient will be reviewed at 1st,3rd day, 7th, 15th postoperative day, 1st month, 3rd month postoperatively. Post- operative radiographs will be taken at 1st day,5th day,1st month and 3rd month.
Postoperative care:
All the patients will be instructed to take strict soft and liquid diet for initial 4 weeks.
All the patients will be advised to maintain oral hygiene by rinsing with 0.2% Chlorhexidine gluconate mouthwash three times a day and warm saline 24 hrs after surgery
All the patients will be advised to avoid trauma to the face.
Arch bar removal will be done after 6 weeks.
Prescribed medications:
Inj. Cefotaxime IV 1gm 12 hourly
Inj. Metronidazole 100ml mg IV 8
hourly
Inj. Dexamethasone 8 mg IV 8
hourly
Inj. Diclofenac sodium 75mg IM 8
hourly for 2 days then orally for next
3 days
Inj. Rantac 50 mg IV 12 hourly for 2
days and then Tab. Ranitidine
150mg B.D. for next 3 days
Inj. Emeset 4mg IV 12 hourly
Mouthwash 0.2% chlorhexidine
gluconate thrice a day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Minimally displaced or unfavourable fractures involving parasymphyseal region.
- •Patients above 18 years of age.
- •Patients medically fit for general anaesthesia( ASA I and ASA II).
- •Non-Comminuted and Non-Infected fractures.
排除标准
- •Edentulous Patients.
- •Medically compromised patients who are not fit to undergo procedure under general anaesthesia.
- •Patient with history of bone pathologies or irradiation of head and neck area.
- •Patients with multiple mandibular fractures and/or with any additional midface fractures.
- •Patients with comminuted fractures of mandible.
- •Patient not willing for surgery.
结局指标
主要结局
To access the fracture stability i.e. to observe any deviation occur from intraoperatively achieved reduction and occlusion, effects on bite force using gnathodynamometer, intraoperative time and occlusion.
时间窗: the estimated time may range upto 3 months
次要结局
- pain and facial nerve paraesthesia and postoperative complications like malunion, delayed union(the estimated time may range upto 3 months)
研究者
Dr Twinkle
Sardar Patel Postgraduate institute of Medical and Dental Sciences