| CTRI Number |
CTRI/2024/08/072866 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of surgical guiding splint in the management of facial fractures |
|
Scientific Title of Study
|
Effectiveness of surgical guiding splint in the management of facial 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 Vanshika Bajpai |
| Designation |
Post- graduate student |
| Affiliation |
Manipal College of Dental Sciences, Manipal, Karnataka |
| Address |
Room no 4, Department of oral and maxillofacial surgery, Manipal college of dental sciences, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7860328764 |
| Fax |
|
| Email |
vanshika.mcodsmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vanshika Bajpai |
| Designation |
Post- graduate student |
| Affiliation |
Manipal College of Dental Sciences, Manipal, Karnataka |
| Address |
Room No 4, Department of Oral and maxillofacial surgery, Manipal college of dental sciences, Karnataka
KARNATAKA
576104
India |
| Phone |
7860328764 |
| Fax |
|
| Email |
vanshika.mcodsmpl2022@learner.manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vanshika Bajpai |
| Designation |
Post- graduate student |
| Affiliation |
Manipal College of Dental Sciences, Manipal, Karnataka |
| Address |
Room No 4, Department of oral and Maxillofacial Surgery, Manipal college of dental sciences, Manipal, Karnataka.
KARNATAKA
576104
India |
| Phone |
7860328764 |
| Fax |
|
| Email |
vanshika.mcodsmpl2022@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Vanshika Bajpai |
| Address |
Room no 4, Department of oral and maxillofacial surgery, Manipal college of dental sciences, Manipal, Karnataka. 576104 |
| 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 Chithra A |
Manipal College Of Dental Sciences, Manipal |
Room no 4, Department of Oral and maxillofacial surgery, Manipal college of dental sciences, Manipal
Udupi
KARNATAKA |
9481939772
chitra.a@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Facial fractures with no co morbidities |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1-All patients with facial Fractures requires reduction and fixation.
2-Patients willing and able to provide informed consent.
|
|
| ExclusionCriteria |
| Details |
1-All patients with facial fractures of conservative management.
2- Severe concomitant medical conditions that may affect the surgical outcome.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time utilized for the reduction
Occlusion: Pre and post trauma occlusion
Ease of reduction and fixation: As described by the surgeon
|
post op 1 week, post op 1 month, post op 3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Operative time is reduced, Surgical hands can be reduced & Optimum reduction is achieved. Surgical outcomes from this study can be utilized in future for better patient care. |
post op 1 week, post op 1 month, post op 3 month |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/09/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Achieving occlusion and anatomic reduction are the key to the success of facial trauma. Reduction of the fracture segment is one of the most important aspect. Usually it is not used for routine facial fracture reduction. However, Reduction of facial fracture in during the operative period is challenging. It effects the occlusion and postoperative comfort and return of the quality of life. Hence use of advanced technologies like 3D planning and preparation of guiding splints will support the operating surgeons in achieving optimum outcome. |