| CTRI Number |
CTRI/2025/07/089963 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How and why facial injuries happen, and their possible impact on the brain |
|
Scientific Title of Study
|
Etiology and patterns of maxillofcaial trauma and its association with Traumatic head injury: A cross sectional study in a tertiary care centre |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rejeti Sampath |
| Designation |
Postgraduate student |
| Affiliation |
KLE Academy of Higher Education and Research |
| Address |
Department of Oral & Maxillofacial surgery, KLE Viswanath Katti Institute of Dental Sciences, Nehru Nagar,Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
07032178566 |
| Fax |
|
| Email |
rejetisampath1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijaylaxmi Shettar |
| Designation |
Professor |
| Affiliation |
KLE Academy of Higher Education and Research |
| Address |
Department Of Oral & Maxillofacial Surgery,KLE VK Institute Of Dental Sciences, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
07032178566 |
| Fax |
|
| Email |
viscollege@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rejeti Sampath |
| Designation |
Postgraduate student |
| Affiliation |
KLE Academy of Higher Education and Research |
| Address |
Department Of Oral & Maxillofacial Surgery,KLE VK Institute Of Dental Sciences, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
07032178566 |
| Fax |
|
| Email |
rejetisampath1@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLES Dr Prabhakar Kore Hospital & Medical Research Centre, Nehru Nagar, Belagavi- 590010, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Rejeti Srinivas Sampath Kumar |
| Address |
KLES Dr Prabhakar Kore Hospital & Medical Research Centre, Nehru Nagar, Belagavi- 590010, Karnataka, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rejeti Srinivas Sampath Kumar |
KLES Dr Prabhakar Kore Hospital & Medical Research Centre, Belagavi |
Department Of Oral & Maxillofacial Surgery,KLE VK Institute Of Dental Sciences,Nehru Nagar, Belagavi
Belgaum
KARNATAKA |
7032178566
rejetisampath1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Etthics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: V892||Person injured in unspecified motor-vehicle accident, traffic, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged above 18 years.
2.Patients reporting to casualty with Maxillofacial Hard tissue trauma (conscious or intubated).
3.Patients willing to undergo Maxillofacial and Neurological examination followed by head CT.
4.Patients who provide informed consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.Patients with Maxillofacial soft tissue trauma.
2.PatientS leaving against medical advice (AMA).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To determine the etiology and risk factors associated with Maxillofacial fractures and their demographic distribution.
2. To assess the various patterns of Maxillofacial fractures and their association with Traumatic Head Injury (THI).
|
At presentation (within 24-72 hours)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Relationship between severity of head injuries & speceific patterns of maxillofacial trauma.
2. Predictive factors for intracranial injuries in patients with facial fractures. |
At the time of presentation (within 24-72 hours) |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
01/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
| Maxillofacial Fractures (MFF) mandates special attention during diagnosis; because of their close anatomical proximity and frequent involvement, the vital structures in the head and neck region must be evaluated whenever head and face are injured. Traumatic Head Injury (THI) is a major cause of morbidity, mortality, and disability and is associated with significant economical and social impact in both developed and underdeveloped countries. Because of close anatomic proximity of the facial skeleton and cranium, it is not surprising that patients with maxillofacial trauma are at increased risk of head injuries. Historically, the facial architecture has been perceived to be a cushion against impact, protecting the neurocranium from severe injury . However, some recent investigations have suggested that the face may actually transmit forces directly to the neurocranium, resulting in more serious brain injury . There is paucity of information in the literature regarding the association between head injuries and facial trauma with debated results of prior studies. The purpose of our prospective study is to evaluate the etiology and patterns of maxillofacial hard tissue trauma and their relationship with Traumatic Head Injury (THI). OBJECIVES:
|
1.To determine the etiology and risk factors associated with
Maxillofacial fractures and their demographic distribution.
|
2.
To assess the various patterns of Maxillofacial fractures and their association
with Traumatic Head Injury (THI). Expected outcome of study: 1. Identification of common causes of
maxillofacial trauma and insights into demographic variations. 2. Quantification of co-occurrence of head
injuries in patients with maxillofacial trauma. 3. Identification of specific patterns or
mechanisms linking facial trauma with intracranial injuries.
4. Determination of predictors for head
injury in cases of facial trauma (e.g. mechanism of injury, severity , or
specific fracture patterns.
| |