| CTRI Number |
CTRI/2024/10/074956 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [Neurologic and skeletal] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Assessment and estimation of quality of life after nerve injury in facial fractures. |
|
Scientific Title of Study
|
Prognostic evaluation of infraorbital nerve injury in isolated unilateral
zygomaticomaxillary complex fractures: A comprehensive preoperative and
postoperative assessment of neurosensory function and quality of life. |
| 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 Mridula nair |
| Designation |
Post graduate Trainee |
| Affiliation |
Thai Moogambigai Dental College and Hospital |
| Address |
Branch 3, Department of Oral and Maxillofacial surgery, Thai Moogambigai Dental college and hospital,Golden George Nagar Mogappair
Chennai
TAMIL NADU
600107
India |
| Phone |
8839109569 |
| Fax |
|
| Email |
mridu2403@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Christopher Jesudas |
| Designation |
Head Of Department |
| Affiliation |
Thai Moogambigai Dental college and hospital |
| Address |
Branch 3, Department of Oral and Maxillofacial surgery, Thai Moogambigai Dental college and hospital, Golden George Nagar Mogappair
Chennai
TAMIL NADU
600107
India |
| Phone |
7871221100 |
| Fax |
|
| Email |
pradeepchris68@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Christopher Jesudas |
| Designation |
Head Of Department |
| Affiliation |
Thai Moogambigai Dental College and Hospital |
| Address |
Branch 3, Department of Oral and Maxillofacial surgery, Thai Moogambigai Dental college and hospital, Golden George Nagar Mogappair
Chennai
TAMIL NADU
600107
India |
| Phone |
07871221100 |
| Fax |
|
| Email |
pradeepchris68@gmai.com |
|
|
Source of Monetary or Material Support
|
| Branch 3, Department of Oral and Maxillofacial surgery, Thai Moogambigai Dental college and hospital, DR. M.G.R Educational and Research institute Golden George Nagar Mugappair Tamil Nadu India Thiruvallur TAMIL NADU 600107 India |
|
|
Primary Sponsor
|
| Name |
Dr. Mridula nair |
| Address |
Branch 3, Department of Oral and Maxillofacial surgery, Thai Moogambigai Dental college and hospital, DR. M.G.R Educational and Research institute Golden George Nagar Mugappair Tamil Nadu India Thiruvallur TAMIL NADU 600107 India |
| 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 Mridula Nair |
Thai Moogambigai Dental College and Hospital |
Branch 3, Department of Oral and Maxillofacial surgery.
Chennai
TAMIL NADU |
8839109569
mridu2403@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional committee of thai moogambigai dental college and hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R930||Abnormal findings on diagnostic imaging of skull and head, not elsewhere classified, (2) ICD-10 Condition: M952||Other acquired deformity of head, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conservative management |
Neurosensory assessment of infraorbital nerve in patient with zygomaticomaxillary fracture undergoing conversative management after post trauma, 3 months and 6 months. |
| Intervention |
Surgical management |
Neurosensory assessment of infraorbital nerve in patient with zygomaticomaxillary fracture undergoing surgical management after post trauma, 3 months and 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with isolated unilateral zygomaticomaxillary fractures.
2. Tenderness at fractured points.
3. Visible depression in the prominence of cheek.
4. Patient aged- 18 years and above.
5. Patient willing to participate in study. |
|
| ExclusionCriteria |
| Details |
1. Patient with bilateral ZMC fracture, comminuted zygomatic fractures, combined Lefort fractures.
2. Patient previous history of neurosensory deficits of the infraorbital nerve. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Neurosensory assessment of infraorbital nerve injury in surgical patients using Pin prick test, cold thermal test, two-point discrimination test, light touch monofilament test, quality of life assessment. |
Time duration will be measured on sensory assessment of Infraorbital nerve just after the trauma then postoperative 3 months and 6 months after surgery
Day 0 after trauma (Pre operative)Neurosensory Assessment of infraorbital nerve
After 3 months- Post operative Neurosensory assessment of Infraorbital nerve
After 6 Months- Post operative Assessment of Infraorbital nerve. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Neurosensory assessment of infraorbital nerve injury in conservative managed patients using Pin prick test, cold thermal test, two-point discrimination test, light touch monofilament test, quality of life assessment. |
Time duration will be measured from after the trauma to conservative management after 3 and 6 months
Day 0 after trauma - Sensory Assessment of infra orbital nerve
3 months Sensory Assessment of infra orbital nerve
6 months Sensory Assessment of infra orbital nerve |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 2 |
|
Date of First Enrollment (India)
|
10/10/2024 |
| 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 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
|
Prognostic evaluation of infraorbital nerve injury in isolated unilateral zygomaticomaxillary complex fractures: A comprehensive preoperative and postoperative assessment of neurosensory function and quality of life.INTRODUCTION-The zygomaticomaxillary complex (ZMC) fractures are the second most common fractures affecting the midfacial skeleton. Neurosensory disturbances of the infraorbital nerve are one of the most common signs of ZMC fractures AIM AND OBJECTIVE-The aim of the study is to analyse neurosensory changes in the infraorbital nerve following isolated unilateral zygomaticomaxillary complex (ZMC) fracture in both surgically and non surgically managed patients and their quality of life. The study is planned to assess neurosensory deficits and outcomes in surgically operated and conservatively managed patient after a follow up of 3 months and 6 months with a brief questionnaire to assess their quality of life post trauma. METHODOLOGY •This is a prospective observational study •The study includes 20 patients with isolated unilateral ZMC fracture,10 in surgical group and 10 in non surgical group. INCLUSION CRITERIA- •Patients diagnosed with isolated unilateral ZMC fractures •Patient age - 18 years and above •Patient willing to participate in study. EXCLUSION CRITERIA- •Patient with bilateral ZMC fracture, comminuted zygomatic fracture, combined Lefort fractures. •Patient previous history of neurosensory deficits of the infraorbital nerve. PARAMETERS ASSESSED 1.Pin prick test 2.Light touch monofilament test 3.Cold thermal test 4.Two point discrimination test 5.Quality of life assessment
Patient assessed – At time of injury After 3 months After 6 months
|