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CTRI Number  CTRI/2018/05/014101 [Registered on: 25/05/2018] Trial Registered Retrospectively
Last Modified On: 25/05/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study on three different methods of bone fixing in the treatment of lower jaw fractures 
Scientific Title of Study   A Comparative study of outcomes of three different bone plating techniques in the treatment of mandibular symphysis or parasymphysis fractures 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
None  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  P Divya Naga Lakshmi 
Designation  Assistant Professor 
Affiliation  Vishnu Dental College 
Address  Department of Oral and maxillofacial Surgery, Room no. 2 Block no. 3, Vishnu Dental College, Vishnupur, Bhimavaram

West Godavari
ANDHRA PRADESH
534208
India 
Phone  9640185785  
Fax    
Email  puvvadadivya87@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kishore Moturi 
Designation  Professor and HOD 
Affiliation  Vishnu Dental College 
Address  Department of Oral and Maxillofacial Surgery, Room no 2, Block 3, Vishnu Dental College, Vishnupur, Bhimavaram

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9849094159  
Fax    
Email  moturik@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kishore Moturi 
Designation  Professor and HOD 
Affiliation  Vishnu Dental College 
Address  Department of Oral and Maxillofacial Surgery, Room no 2, Block 3, Vishnu Dental College, Vishnupur, Bhimavaram

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9849094159  
Fax    
Email  moturik@gmail.com  
 
Source of Monetary or Material Support  
Self funded  
 
Primary Sponsor  
Name  P Divya Naga Lakshmi 
Address  Assistant Professor, Department of Oral and Maxillofacial surgery Vishnu Dental College, Vishnupur, Bhimavaram 
Type of Sponsor  Other [Self] 
 
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 
P Divya Naga Lakshmi  Vishnu Dental College  Department of Oral And Maxillofacial Surgery, Room no.2 Block no 3, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH 
9640185785

puvvadadivya87@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee, Vishnu dental college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  An otherwise healthy individual who sustained maxillofacial trauma, with fractures of isolated mandibular symphysis or parasymphysis fractures requiring open reduction and internal fixation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  2.5mm 6 hole with gap stainless steel locking plate  High grade medical stainless steel 2.5 mm 6 hole locking plate manufactured by Sirag Surgicals, Chennai. Plates would remain inside until, any symptomatic indication for removal exists (at least for a period of 6months) 
Comparator Agent  2.5 mm 4 hole with gap Stainless steel Miniplates  Two High grade Medical stainless steel miniplates manufactured by Sirag Surgicals, Chennai. Plates would remain inside until, any symptomatic indication for removal exists (at least for a period of 6months) 
Intervention  2mm 4 hole 3- Dimensional single stainless steel miniplate   3 Dimensional single High grade medical stainless steel plate manufactured by Sirag Surgicals, Chennai. Plates would remain inside until, any symptomatic indication for removal exists (at least for a period of 6months) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Simple fractures of the symphysis or parasymphysis requiring open reduction and internal fixation
2) Patients presenting to the department within 48hrs of injury
3) Patient consenting for the study 
 
ExclusionCriteria 
Details  1) Subjects with associated comminuted, displaced fractures of other regions of the mandible
2) Severe medically compromised patients and patients on immunosuppressive drugs
3) Patients with gross infection at the site of fracture
4) Edentulous patients
5) Associated midface trauma
6) Patients having neurological deficit or neurological related disorders
7) Severely periodontally compromised patients
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Treatment outcomes like stability of fractured fragments and occlusal stability using three different bone plating techniques  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
wound healing or soft tissue dehiscence, vitality of teeth, palpability of plates and radio graphical displacement of fractured fragments  3 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   28/11/2017 
Date of Study Completion (India) 27/03/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 27/03/2018 
Estimated Duration of Trial   Years="0"
Months="3"
Days="29" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
PURPOSE - The purpose of the study is to evaluate outcomes for three different bone plating techniques used in the treatment of mandibular symphysis/ parasymphysis fractures.
PATIENTS AND METHODS: 30 patients with isolated and undisplaced mandible fractures were selected who required open reduction and internal fixation were included in the study. Patients were divided in to 3 groups, Group I – 2.5mm locking Stainless Steel plate used, Group II – two 2.5 mm standard miniplates were used and Group III – 2.0 mm 3-D miniplate were used. Patients were evaluated for clinical and radiographic parameters during a 3 month follow-up period and data subjected to statistical analysis.
RESULTS: Group I (n=10) had no incidence of complications associated with plating and in group II (n=10) 3 patients had discrepancies in occlusion required IMF during first week after surgery but noticed a good healing of fracture site with no discrepancies in occlusion at 3 month follow-up.2 of the patients had loss of vitality of teeth associated with plating at 3 week follow-up. Patients in group III (n=10) 2 of the patients had discrepancies in occlusion requiring IMF and loss of vitality in 2 patients. Wound dehiscence associated with infection was noticed in 1 patient during 6th postoperative day which healed successfully after local debridement and use of systemic antibiotics. Overall complications had no statistical significance between group II and III, but had significance in comparison with group I.
CONCLUSION – The use of 2 miniplates and 3D plates was associated with more postoperative complications than the use of single locking plate at lower border, but all the three techniques produced sufficient stability for healing.
 
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