| CTRI Number |
CTRI/2024/09/073449 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
25/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Development of Facial Trauma Disability guidelines in Indian scenario by incorporation of Image matching technology |
|
Scientific Title of Study
|
Development of Facial Trauma Disability guidelines for Indian scenario and evaluation of facial disfigurement in patients with Maxillofacial Trauma using Image matching technology. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anupam Singh |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Dept. of Oral & Maxillofacial Surgery
Manipal College of Dental Sciences, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9535619076 |
| Fax |
|
| Email |
anupamsingh15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Srikanth G. |
| Designation |
Professor & Head |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Dept. of Oral & Maxillofacial Surgery
Manipal College of Dental Sciences, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9986455201 |
| Fax |
|
| Email |
gadi_mds@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anupam Singh |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Dept. of Oral & Maxillofacial Surgery
Manipal College of Dental Sciences, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9535619076 |
| Fax |
|
| Email |
anupamsingh15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences, Manipal, Karnataka - 576104 |
|
|
Primary Sponsor
|
| Name |
Anupam Singh |
| Address |
Dept. of Oral & Maxillofacial Surgery
Manipal College of Dental Sciences
Manipal
Karnataka
India 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 Anupam Singh |
Manipal College of Dental Sciences, Manipal |
Dept. of Oral & Maxillofacial Surgery
Manipal College of Dental Sciences
Manipal
Udupi
KARNATAKA |
9535619076
anupamsingh15@gmail.com |
|
|
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 |
| Patients |
(1) ICD-10 Condition: S029||Fracture of unspecified skull andfacial bones, (2) ICD-10 Condition: V99||Unspecified transport accident, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria for patients - All patients aged 18 years and more, diagnosed with Maxillofacial fracture and under the treatment of same are included. Patients with follow up data at 6 months for evaluation of residual deformity.
Inclusion Criteria for caregivers – Any caregiver attending to a patient presenting with Maxillofacial fracture and under the treatment of same are included.
Inclusion Criteria for clinicians – Oral and Maxillofacial Surgeons who have experience in the management of Maxillofacial Trauma and who are willing to participate will be invited to participate.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria: For Delphi - Patients who cannot comprehend in English |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Facial Disfigurement index |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oral Health Quality of Life |
6 months |
|
|
Target Sample Size
|
Total Sample Size="134"
Sample Size from India="134"
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)
|
09/09/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1. Lack of Indian-Specific Guidelines: There
have been suggestions for development of India specific guidelines for
assessment of facial disability. For a comprehensive and holistic guideline, it
is imperative to include the opinions of the subject/field experts to bring
about amendment in the existing guidelines or develop a new guideline. 2.
Inclusion of Facial Disfigurement and Psychosocial Criteria: The current
assessment guidelines, which focus predominantly on physical or functional
factors and not adequately address the facial disfigurement component and its
psychosocial impact. 3. Use of Image matching Technology: The current
assessment methods for facial disfigurement rely primarily on subjective
evaluations, potentially leading to inconsistencies and biases. The proposal
introduces the idea of using image matching technology for the objective
evaluation of facial disfigurement. Further research is needed to assess the
feasibility, accuracy, and practicality of implementing these technologies in
the Indian healthcare system. 4. Lack of Consensus: There is a lack of
consensus or standardized criteria for facial trauma disability assessment,
which can lead to inconsistencies in assessments and potentially unfair
outcomes for individuals. The use of Delphi process to gather expert opinions
and reach consensus can potentially help in development of a guideline which
has wider acceptance.
By providing more accurate and comprehensive
guidelines, the research can improve patient care and rehabilitation, leading
to better outcomes for individuals with facial trauma. By incorporating
psychosocial criteria, the study recognizes the multifaceted impact of facial
trauma. This holistic approach is essential for addressing not only physical
impairments but also the emotional and psychological well-being of patients.
The investigation evaluates the feasibility
and accuracy of image matching technology for objective assessment of facial
disfigurement. If successful, this technology can provide standardized and
unbiased evaluations, reducing subjectivity and inconsistency in assessments.
The study has potential implications for
legal judgments related to disability claims. More comprehensive and accurate
assessment criteria can lead to fairer outcomes in legal cases, ensuring that
individuals receive the compensation and support they deserve. |