| CTRI Number |
CTRI/2019/09/021418 [Registered on: 25/09/2019] Trial Registered Prospectively |
| Last Modified On: |
23/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
“A Comparative Evaluation Of 2.0 mm Titanium Mini Plates And 3D Titanium Locking Plates In Mandibular Osteosynthesis- A Randomised Clinical Prospective Study†|
|
Scientific Title of Study
|
“A Comparative Evaluation Of 2.0 mm Titanium Mini Plates And 3D Titanium Locking Plates In Mandibular Osteosynthesis- A Randomised Clinical Prospective Study†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gaurav Mittal |
| Designation |
Principal HOD |
| Affiliation |
Institute of dental studies & technologies |
| Address |
Institute of dental studies & technologies, N.H 58
Delhi Meerut Road, Kadrabad, Modinagar, Ghaziabad (U.P)
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
08265826384 |
| Fax |
|
| Email |
drgauravmittal@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akash Bhatt |
| Designation |
PG Resident |
| Affiliation |
Institute of dental studies & technologies |
| Address |
Institute of dental studies & technologies, N.H 58
Delhi Meerut Road, Kadrabad, Modinagar, Ghaziabad (U.P)
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
8265826384 |
| Fax |
|
| Email |
akashbhatt2005@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akash Bhatt |
| Designation |
PG Resident |
| Affiliation |
Institute of dental studies & technologies |
| Address |
Institute of dental studies & technologies, N.H 58
Delhi Meerut Road, Kadrabad, Modinagar, Ghaziabad (U.P)
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
8265826384 |
| Fax |
|
| Email |
akashbhatt2005@gmail.com |
|
|
Source of Monetary or Material Support
|
| BK Surgicals,Byadgi, Hyderabad
Axpert Enterprise, Ahmedabad |
|
|
Primary Sponsor
|
| Name |
Institute of dental studies technologies |
| Address |
Institute of dental studies & technologies, Delhi Meerut Road, Kadrabad, Modinagar, Ghaziabad(U.P) |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Akash Bhatt |
Institute of dental studies & technologies, Delhi Meerut Road, Kadrabad, Modinagar, Ghaziabad(U.P) |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gaurav Mittal |
Department of Oral & Maxillofacial Surgery |
Institute of dental studies & technologies, N.H 58
Delhi Meerut Road, Kadrabad, Modinagar, Ghaziabad (U.P)
Ghaziabad
UTTAR PRADESH |
08265826384
drgauravmittal@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical commitee Institute of dental studies & technologies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R65||Symptoms and signs specifically associated with systemic inflammation and infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3D locking titanium miniplates ,2.0 mm conventional titanium miniplates. |
2mm with locking screws |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with symphysis and parasymphysis mandibular fractures. |
|
| ExclusionCriteria |
| Details |
Patients who refuses to give consent.
Patients with infected fractures.
Communited fractures.
Atrophic mandible.
Pathological fractures.
ASA III & IV. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| In primary outcomes it was noted that 3D plates used in patients gives increase stability, decreases time duration of surgery. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| in secondary outcomes it was noted that the bite force increase in the patients treated with 3D plates after 1 week of surgery. post op pain was minimal. |
1.5 years |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
25/09/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Mandibular fractures are the second most common facial fracture following nasal fracture. The position, prominence, anatomic configuration, mobility and less bone support of the mandible make it one of the most frequent facial bones to be fractured.The treatment of symphysis/parasymphysis fractures can be divided into 2 major treatment methods: closed reduction (CR) and open reduction and internal fixation (ORIF). Miniplates have been the preferred ï¬xation method in craniomaxillofacial surgery because of their relatively small size, adaptability, ease of placement and intraoral approach. However controversies abound with respect to rigidity and stability provided by miniplates especially in angle fractures and comminuted fractures, as they are considered as semirigid ï¬xation methods by followers of AO/ASIF. Farmand developed 3-D plate with quadrangular design formed by joining two miniplates with interconnecting crossbars. The stability is gained over a deï¬ned surface area in three dimensions due to its conï¬guration, not by thickness or length and offers good resistance against torsional forces. Author recommended 1.0 mm thick standard plates in mandibular osteosynthesis. To overcome the disadvantages of loosening of hardware and need of perfect adaptation of miniplates a new Internal Mini-Locking-System was developed. Since then many surgeons have been debating between the use of conventional miniplates, 3D plates and 3D locking plates in maxillofacial surgery. Nilima J. Budhraja et. al advocated that 3D locking plate is an alternative approach with a similar outcome profile to miniplates whereas Denny George et al. advocated that 3D titanium locking miniplates are better in fracture stabilization for anterior mandibular fractures when compared with conventional titanium miniplates. Previous studies encourage to carry forward the debate between conventional miniplates and 3 D locking plates requiring further research in this field. The aim of the study is to compare the efficacy, stability and rigidity of 3D titanium locking plates with 2.0 mm titanium miniplates. |