| CTRI Number |
CTRI/2024/09/073723 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective |
| Study Design |
Other |
|
Public Title of Study
|
Check the outcome by comparing the use of two instruments in difficult accessible mandibular fractures. |
|
Scientific Title of Study
|
Comparison of clinical outcomes and complications in the surgical management of mandibular body and angle fractures using right angled drills versus straight drills- A surgeons perspective |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SMARANJIT SAHA |
| Designation |
MDS FIRST YEAR |
| Affiliation |
MANIPAL COLLEGE OF DENTAL SCIENCE |
| Address |
Department of oral and maxillofacial surgery, room no 4, Manipal college of dental science, manipal
Department of oral and maxillofacial surgery, room no 4, Manipal college of dental science, manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7908216331 |
| Fax |
|
| Email |
smaranjit.manipalomfs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANAND |
| Designation |
associate professor |
| Affiliation |
MANIPAL COLLEGE OF DENTAL SCIENCE |
| Address |
Department of oral and maxillofacial surgery, room no 4, Manipal college of dental science, manipal
Department of oral and maxillofacial surgery, room no 4, Manipal college of dental science, manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9742354052 |
| Fax |
|
| Email |
drandymanipal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SREEA ROY |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
MANIPAL COLLEGE OF DENTAL SCIENCE |
| Address |
Department of oral and maxillofacial surgery, room no 4, Manipal college of dental science, manipal
Department of oral and maxillofacial surgery, room no 4, Manipal college of dental science, manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9986455201 |
| Fax |
|
| Email |
srre.roy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of oral and maxillofacial surgery, room no 4, Manipal college of dental science, manipal |
|
|
Primary Sponsor
|
| Name |
Smaranjit Saha |
| Address |
Department of oral and maxillofacial surgery, room no 4, Manipal college of dental science, manipal |
| 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 Smaranjit saha |
manipal college of dental science |
Department of oral and maxillofacial surgery, room no 4, Manipal college of dental science, manipal
Udupi
KARNATAKA |
7908216331
smaranjit.maniplaomfs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and hospiyal institutional ethics committee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S026||Fracture of mandible, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
1. Patients with mandibular fractures- body, angle, ramus, condyles
2. Patients aged between 12 to 80 with ASA grading 1 to 3
3. Patients who will be managed surgically
4. Patients who are willing for the study
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1. Patients with infected fractures
2. Patients with tissue loss on the affected site
3. Patients who are not willing for the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary- Surgeons perspective
1) Ease of handling
2) Manoeuvrability in tight spaces
3) Visibility of site
4) Tactile feedback
5) Retraction injury
6) Overall satisfaction with drill performance and hardware fixation
|
day 1,7,14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary-Patients perspective
1) Pain
2) edema |
day 1,7,14 |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
16/09/2024 |
| 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="1"
Months="6"
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
|
this is a prospective observational study to compare the clinical outcomes and complications in surgical management of mandibular body and angle fractures using right angled drills versus straight drills in surgeons perspective. the primary outcome and secondary outcomes to be assessed to dermic the efficiency in using the right angled drills in such fractures. |