| CTRI Number |
CTRI/2024/04/065628 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
3D plates and conventional miniplates in treatment of mandibular fractures . |
|
Scientific Title of Study
|
Comparative evaluation of 3d Locking Plates, 3d Non-locking plates, Locking and Non- locking Conventional Miniplates in the treatment of Mandibular fractures. |
| 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 Smile Singla |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College And Research Institute, Bangalore |
| Address |
Department of Oral And Maxillofacial Surgery, Government Dental College And Research Institute, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9781928537 |
| Fax |
|
| Email |
smilesingla7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Girish Giraddi |
| Designation |
Professor And Head Of Department |
| Affiliation |
Government Dental College And Research Institute, Bangalore |
| Address |
Department of Oral And Maxillofacial Surgery, Government Dental College And Research Institute, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9740098199 |
| Fax |
|
| Email |
girishgiraddi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Girish Giraddi |
| Designation |
Professor And Head Of Department |
| Affiliation |
Government Dental College And Research Institute, Bangalore |
| Address |
Department of Oral And Maxillofacial Surgery, Government Dental College And Research Institute, Bangalore
KARNATAKA
560002
India |
| Phone |
9740098199 |
| Fax |
|
| Email |
girishgiraddi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College And Research Institute Bangalore |
|
|
Primary Sponsor
|
| Name |
Dr Smile Singla |
| Address |
Department of Oral And Maxillofacial Surgery, Government Dental College And Research Institute, Bangalore |
| 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 Smile Singla |
Government Dental College And Research Hospital Bangalore |
Room No 2B Department of Oral And Maxillofacial Surgery KR Market Bangalore 560002
Bangalore
KARNATAKA |
9781928537
smilesingla7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Dental College And Research Institute Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3D Locking Miniplates |
3D locking miniplates will be used in the participants having mandibular fractures. The participants will be assessed for occlusion, fracture stability, pain , paresthesia, infection, operating time, screw loosening and wound dehiscence at baseline, 3rd day, 15th day and 1 month using radiographs , clinical examination and pre validate questionnaire. |
| Comparator Agent |
3D Non- Locking Miniplates |
3D non-locking miniplates will be used in the participants having mandibular fractures. The participants will be assessed for occlusion, fracture stability, pain , paresthesia, infection, operating time, screw loosening and wound dehiscence at baseline, 3rd day, 15th day and 1 month using radiographs , clinical examination and pre validate questionnaire. |
| Comparator Agent |
Conventional Locking Miniplates |
Conventional locking miniplates will be used in the participants having mandibular fractures. The participants will be assessed for occlusion, fracture stability, pain , paresthesia, infection, operating time, screw loosening and wound dehiscence at baseline, 3rd day, 15th day and 1 month using radiographs , clinical examination and pre validate questionnaire. |
| Comparator Agent |
Conventional Non-Locking Miniplates |
Conventional non-locking miniplates will be used in the participants having mandibular fractures. The participants will be assessed for occlusion, fracture stability, pain , paresthesia, infection, operating time, screw loosening and wound dehiscence at baseline, 3rd day, 15th day and 1 month using radiographs , clinical examination and pre validate questionnaire. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All clinically and radiographically confirmed mandibular fractures.
Healthy subject ASA-1&2. |
|
| ExclusionCriteria |
| Details |
Medically compromised subject ASA-3& 4.
Edentulous subject.
Subject with comminuted fractures.
Subjects not able to come for follow up and those who do not give consent to be part of the study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Occlusion : Present or absent
Fracture stability : By checking interfragmentary mobility manually.
Pain : Based on VAS |
At baseline
3rd day
15th day
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Paresthesia
Infection
Operating time
Screw loosening
Wound dehiscence |
At baseline
3rd day
15th day
1 month |
|
|
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 3 |
|
Date of First Enrollment (India)
|
25/04/2024 |
| 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="1" |
|
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
|
THIS IS A PROSPECTIVE STUDY COMPARING THE EFFICACY OF CONVENTIONAL LOCKING AND NONLOCKING MINIPLATES, 3D LOCKING AND NON LOCKING MINIPLATES. SUBJECTS WILL BE SELECTED BASED ON INCLUSION AND EXCLUSION CRITERIA VISITING THE OUT PATIENT DEPARTMENT OF OMFS FOR THE TREATMENT OF MANDIBULAR FRACTURES. SUBJECTS WILL BE DIVIDED RANDOMLY INTO FOUR GROUPS. SUBJECTS WILL BE TREATED ACCORDING TO RESPECTIVE STUDY GROUP AND RESULTS WILL BE EVALUATED AT AN INTERVAL OF 1 DAY, 3RD DAY, 15TH DAY, 30TH DAY FOR PRIMARY AND SECONDARY OUTCOMES. |