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CTRI Number  CTRI/2017/08/009587 [Registered on: 31/08/2017] Trial Registered Retrospectively
Last Modified On: 28/08/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compair two different plating systems delta plates and miniplates for treatment of lower jaw mandibular condylar fractures in adults 
Scientific Title of Study   Comparative evaluation of clinical outcomes using delta plates and conventional miniplates for internal fixation of mandibular condylar fractures in adults 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Suraj Ahuja 
Designation  Post Graduate Student 
Affiliation  MGM Dental College and Hospital 
Address  MGM Dental College and Hospital,Department Of Oral & Maxillofacial Surgery,2nd floor,room No 3,Junction of NH4 and 410209, Sion - Panvel Expy, Sector 18, Navi Mumbai, Maharashtra

Raigarh
MAHARASHTRA
410209
India 
Phone  9819985991  
Fax    
Email  drahujasuraj@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Usha Asnani 
Designation  Guide 
Affiliation  MGM Dental College and Hospital 
Address  MGM Dental College and Hospital,Department Of Oral & Maxillofacial Surgery,2nd floor,room No 3,Junction of NH4 and 410209, Sion - Panvel Expy, Sector 18, Navi Mumbai, Maharashtra

Raigarh
MAHARASHTRA
410209
India 
Phone  9820897181  
Fax    
Email  drushaasnani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Suraj Ahuja 
Designation  Post Graduate Student 
Affiliation  MGM Dental College and Hospital 
Address  MGM Dental College and Hospital,Department Of Oral & Maxillofacial Surgery,2nd floor,room No 3,Junction of NH4 and 410209, Sion - Panvel Expy, Sector 18, Navi Mumbai, Maharashtra

Raigarh
MAHARASHTRA
410209
India 
Phone  9819985991  
Fax    
Email  drahujasuraj@gmail.com  
 
Source of Monetary or Material Support  
MGM Dental College Hospital, Junction of NH4 and 410209, Sion - Panvel Expy, Sector 18, Navi Mumbai, Maharashtra 
 
Primary Sponsor  
Name  MGM Dental College Hospital 
Address  Junction of NH4 and 410209, Sion - Panvel Expy, Sector 18, Navi Mumbai, Maharashtra 
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 Suraj Ahuja  MGM Dental College & Hospital  Department of Oral & Maxillofacial Surger, 2nd floor,Room No.3, Junction of NH4 and 410209, Sion - Panvel Expy, Sector 18, Navi Mumbai, Maharashtra
Raigarh
MAHARASHTRA 		 9819985991

drahujasuraj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MGMDCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  With mandibular condylar fractures ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Delta Plate  management of mandibular condylar fracture 
Comparator Agent  Mini Plates  management of mandibular condylar fracture 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patients in the age group of 18 – 60 years.
2 Non-comminuted, displaced, extra-articular mandibular condyle fracture requiring open reduction with internal fixation for treatment.
3 Patients who have sustained fracture in the past two weeks.
4 Bilateral Mandibular condylar fractures.
5 Patients with concomitant fractures of mandible.
6 Patients with a dentition complete enough to apply a stable Erich arch bar.
7 Subject willingness.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate the efficacy of Conventional titanium mini plate system.
2. To evaluate the efficacy of Delta titanium plate system.
 		 Immediate Post Operatively,
1 week
4 week
3 months
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1 To evaluate complications of Conventional miniplates.
2 To evaluate complications of Delta plate.
3 To evaluate the stability of Conventional miniplates
4 To evaluate the stability of Delta plate.
5 To compare the advantages and disadvantages of Delta plate over the conventional miniplates.
 		 8 months
9 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/11/2011 
Date of Study Completion (India) 02/01/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 12/07/2017 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
A prospective study was performed on 20 patients with subcondylar fracture requiring open reduction and internal fixation for their management. Patients were randomly divided in two groups, patients under Group A [N=10] were treatment using delta plate while under Group B [N=10] using conventional miniplates. There was no statically difference between delta plates and conventional miniplates for internal fixation of mandibular condylar fractures in adults. However, time taken for adaptation of the delta plates & ease of adaptation was significantly lower than that required for the two miniplates [p=0.000]. The study results indicated that delta plate and miniplate are equally effective in terms of long-term clinical success in the management of mandibular subcondylar fractures in adults. The delta plates are superior in terms of handling characteristics, such as, ease of adaptation and time required for adaptation as only one plate and four screws are required as compared to two plates and eight screws. 
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