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CTRI Number  CTRI/2025/11/097402 [Registered on: 13/11/2025] Trial Registered Prospectively
Last Modified On: 13/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparative study between three dimensional Z plates and two conventional miniplates for internal fixation of mandibular parasymphysis fracture 
Scientific Title of Study   comparative study between three dimensional Z plates and two conventional miniplates for the internal fixation of mandibular parasymphysis fracture 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Twinkle 
Designation  PG Resident 
Affiliation  Sardar Patel Postgraduate institute of Medical and Dental Sciences 
Address  02, Department of Oral and Maxillofacial Surgery, Sardar Patel Postgraduate institute of Medical and Dental Sciences, Chaudhary Vihar Uthrathia Raebareily Road Lucknow

Lucknow
UTTAR PRADESH
226025
India 
Phone  9416791552  
Fax    
Email  aggarwaltwinkle13@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gaurav singh 
Designation  Head Of The Department 
Affiliation  Sardar Patel Postgraduate institute of Medical and Dental Sciences 
Address  02, Department of Oral and Maxillofacial Surgery, Sardar Patel Postgraduate institute of Medical and Dental Sciences, Chaudhary Vihar Uthrathia Raebareily Road Lucknow
02, Department of Oral and Maxillofacial Surgery, Sardar Patel Postgraduate institute of Medical and Dental Sciences, Chaudhary Vihar lko
Lucknow
UTTAR PRADESH
226025
India 
Phone  9415086536  
Fax    
Email  dr.gaurav1502@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Twinkle 
Designation  PG Resident 
Affiliation  Sardar Patel Postgraduate institute of Medical and Dental Sciences 
Address  02, Department of Oral and Maxillofacial Surgery, Sardar Patel Postgraduate institute of Medical and Dental Sciences, Chaudhary Vihar Uthrathia Raebareily Road Lucknow
02, Department of Oral and Maxillofacial Surgery, Sardar Patel Postgraduate institute of Medical and Dental Sciences, Chaudhary Vihar Uthrathia Raebareily Road Lucknow
Lucknow
UTTAR PRADESH
226025
India 
Phone  9416791552  
Fax    
Email  aggarwaltwinkle13@gmail.com  
 
Source of Monetary or Material Support  
Department of oral and maxillofacial surgery, sardar patel postgraduate insititute of medical and dental sciences, lucknow, uttar pradesh, 226025, India 
 
Primary Sponsor  
Name  sardar patel postgraduate insititute of medical and dental sciences, lucknow 
Address  raebareilly road lucknow 226025 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Twinkle  Sardar Patel Postgraduate Insititute Of Medical And Dental Sciences, Lucknow  02, Department of Oral and Maxillofacial Surgery
Lucknow
UTTAR PRADESH 
09416791552

aggarwaltwinkle13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Conventional miniplates  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 2 conventional miniplates at lower border of mandible. 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.  
Comparator Agent  Three Dimentional Z plate  After exposure of the fracture site, anatomic reduction will be achieved followed by fixation using 2mm Z plate at lower border of mandible. In this, 2 mm Z plate will be placed at lower border of mandible secured with 8mm and 6 mm 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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
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.
 
the estimated time may range upto 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
pain and facial nerve paraesthesia and postoperative complications like malunion, delayed union  the estimated time may range upto 3 months 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   24/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  24/11/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.


 
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