| CTRI Number |
CTRI/2025/04/085946 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between thickplates and thinplates in treatment of face fracture |
|
Scientific Title of Study
|
Comparison of microplates vs miniplates in managment of ZMC fracture |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nandhini S |
| Designation |
Post graduate student |
| Affiliation |
Sree Balaji dental college and hospital |
| Address |
Room no 03, Department of oral and maxillofacial surgery, Sree Balaji Dental college and hospital, Velachery main road, Narayanapuram, Pallikaranai, Chennai.
Chennai
TAMIL NADU
600100
India |
| Phone |
8810398600 |
| Fax |
|
| Email |
nansiv7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saravanakumar B |
| Designation |
Professor |
| Affiliation |
Sree Balaji dental college and hospital |
| Address |
Room no 03, Department of oral and maxillofacial surgery, Sree Balaji Dental college and hospital, Velachery main road, Narayanapuram, Pallikaranai, Chennai.
Chennai
TAMIL NADU
600100
India |
| Phone |
9444385846 |
| Fax |
|
| Email |
drsaranomfs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saravanakumar B |
| Designation |
Professor |
| Affiliation |
Sree Balaji dental college and hospital |
| Address |
Room no 03, Department of oral and maxillofacial surgery, Sree Balaji Dental college and hospital, Velachery main road, Narayanapuram, Pallikaranai, Chennai.
TAMIL NADU
600100
India |
| Phone |
9444385846 |
| Fax |
|
| Email |
drsaranomfs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Balaji Dental college and hospital, Velachery main road, Narayanapuram, Pallikaranai, Chennai 600100 |
|
|
Primary Sponsor
|
| Name |
Nandhini S |
| Address |
Room no 03, Department of oral and maxillofacial surgery, Sree Balaji Dental college and hospital, Velachery main road, Narayanapuram, Pallikaranai, Chennai - 600100 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nandhini S |
Sree Balaji dental college and hospital |
Room no 03, Department of Oral and maxillofacial surgery, Velachery main road, Narayanapuram, Pallikaranai, Chennai 600100
Chennai
TAMIL NADU |
8870398600
nansiv7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee (Clinical trail) Sree Balaji Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M265||Dentofacial functional abnormalities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Microplates |
For fracture occurring in ZMC region microplate fixation is used. |
| Comparator Agent |
Miniplates |
For fracture occurring in ZMC region miniplate fixation is used. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with recent zygomaticomaxillary complex fracture.
Dentate or partially edentulous patient.
Patient who give their consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Infected fracture sites or wounds.
Comminuted fractures.
Patients unfit for undergoing treatment under general anaesthesia.
Medically compromised patients. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fracture reduction
Fracture stabilisation |
Immediate post op, 1 week, 3 week, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Plate palpability
Symmetry of face
Plate exposure |
3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 4 |
|
Date of First Enrollment (India)
|
05/05/2025 |
| 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="1"
Months="6"
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
|
The study aims to compare microplate vs miniplate in the management of ZMC fracture. ZMC fracture refers to facial fractures occuring in midthird of face. This study compares between microplates and miniplates which are used for fixation of fracture segments. |