FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/079893 [Registered on: 03/02/2025] Trial Registered Prospectively
Last Modified On: 02/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparing Outcomes: Sub-Brow and Lateral Eyebrow Approaches for Fronto-Zygomatic Fracture Repair 
Scientific Title of Study   Comparison of Sub-Brow Versus Lateral Eyebrow Approach in Open Reduction and Internal Fixation of Frontozygomatic Fractures: A Comparative Study 
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 ANDREW FRANCIS DEVOTTA 
Designation  Post graduate student 
Affiliation  Adhiparasakthi Dental College and Hospital 
Address  Room no:8,Department of Oral and Maxillofacial Surgery,Adhiparasakthi Dental College and Hospital,Melmaruvathur

Kancheepuram
TAMIL NADU
603319
India 
Phone  7395980802  
Fax    
Email  andrewdevotta238@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR JAMES ANTONY BHAGAT M  
Designation  Professor 
Affiliation  Adhiparasakthi Dental College and Hospital 
Address  Room no:8,Department of Oral and Maxillofacial Surgery,Adhiparasakthi Dental College and Hospital,Melmaruvathur

Kancheepuram
TAMIL NADU
603319
India 
Phone  9941626677  
Fax    
Email  jamesbhagat@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR ANDREW FRANCIS DEVOTTA 
Designation  Post graduate student 
Affiliation  Adhiparasakthi Dental College and Hospital 
Address  Room no:8,Department of Oral and Maxillofacial Surgery,Adhiparasakthi Dental College and Hospital,Melmaruvathur

Kancheepuram
TAMIL NADU
603319
India 
Phone  7395980802  
Fax    
Email  andrewdevotta238@gmail.com  
 
Source of Monetary or Material Support  
Adhiparasakthi Dental College and Hospital, Room No: 8, Ground floor, Department of Oral and Maxillofacial surgery, Adhiparasakthi Dental College and Hospital, Melmaruvathur- 603319 Kancheepuram TAMIL NADU  
 
Primary Sponsor  
Name  DR ANDREW FRANCIS DEVOTTA 
Address  Room no:8,Department of Oral and Maxillofacial Surgery,Adhiparasakthi Dental College and Hospital,Melmaruvathur 
Type of Sponsor  Other [Self ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR ANDREW FRANCIS DEVOTTA  Adhiparasakthi Dental College and Hospital  Room no:8,Department of Oral and Maxillofacial Surgery,Adhiparasakthi Dental College and Hospital,Melmaruvathur-603319.
Kancheepuram
TAMIL NADU 
7395980802

andrewdevotta238@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Adhiparasakthi Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S024||Fracture of malar, maxillary and zygoma bones,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Lateral Eyebrow Approach for Fixation of Frontozygomatic Fractures  In the clinical evaluation of frontozygomatic fractures, the diagnosis will be made using computed tomography (CT) of the facial bones. An extraoral approach will be used to expose the fracture line, and an intraoral/extraoral incision will be placed if there is an additional fracture to be managed. The frontozygomatic suture region will be exposed using the lateral eyebrow approach. Intraoperative parameters will include the surgical field (bleeding), measured using Frommes scale, and the time taken to reach the fractured site, which will be evaluated using a stopwatch. Patients will then be discharged with instructions and postoperative medications and asked to report back for further assessment and evaluation of pain on the 1st day, 7th day, and 30th day (using the Visual Analog Scale). Postoperative scarring will be evaluated on the 7th day, 30th day, and 60th day (using the Modified Vancouver Scar Scale). Postoperative edema will be evaluated on the 1st day, 7th day, and 14th day.  
Intervention  Sub-Brow Approach for Fixation of Frontozygomatic Fractures  In the clinical evaluation of frontozygomatic fractures, the diagnosis will be made using computed tomography (CT) of the facial bones. An extraoral approach will be used to expose the fracture line, and an intraoral/extraoral incision will be placed if there is an additional fracture to be managed. The frontozygomatic suture region will be exposed using the sub brow approach. Intraoperative parameters will include the surgical field (bleeding), measured using Frommes scale, and the time taken to reach the fractured site, which will be evaluated using a stopwatch. Patients will then be discharged with instructions and postoperative medications and asked to report back for further assessment and evaluation of pain on the 1st day, 7th day, and 30th day (using the Visual Analog Scale). Postoperative scarring will be evaluated on the 7th day, 30th day, and 60th day (using the Modified Vancouver Scar Scale). Postoperative edema will be evaluated on the 1st day, 7th day, and 14th day.  
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patients who are fit for procedures under general anesthesia between age group of 16 to 50 years will be included ( ASA I and II)
2. Patients with zygomatico maxillary complex fractures involving the frontozygomatic suture  
 
ExclusionCriteria 
Details  1.Patients who are not willing to participate in the study
2.Patients unfit for surgery under general anesthesia ASA (III and IV)
3. Patients with zygomatico maxillary complex
fractures not involving the frontozygomatic suture
4. Patients below 16 years of age.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain, scarring, surgical field, post operative edema and time in comparison of sub brow versus lateral eyebrow approach in fixation of frontozygomatic fractures  Pain at 1st, 7th and 30th day, Scarring at 7th, 30th and 60th day, post operative edema at 1st, 7th and 14th day 
 
Secondary Outcome  
Outcome  TimePoints 
surgical field and time taken  Intra operatively 
 
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 3/ Phase 4 
Date of First Enrollment (India)   17/02/2025 
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="5"
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   INTRODUCTION :
 The zygomatic complex is responsible for the mid-facial contour and for the protection of the orbital contents.
Zygomaticomaxillary fractures, also known as tripod fractures, are usually the result of a direct blow to the body of the zygoma.
Tripod fracture consists of (a) zygomatic arch fracture, (b) fracture of the lateral orbital wall, and (c) fracture of the inferior orbital floor.
Fractures of the zygomatic complex are among the most frequent in maxillofacial trauma.
 There are different surgical approaches mentioned in the literature for the fixation of frontozygomatic suture in zygomaticomaxillary complex fractures; such as lateral eyebrow, lateral upper blepharoplastyHowever recent study has showed the use of sub brow approach for the frontozygomatic suture region. The aim of our study is to assess intra-operative and post-operative parameters such as pain, scarring, time taken to reach fractured site, surgical field(bleeding),post operative edema after fixation of frontozygomatic suture in zygomaticomaxillary complex fractures using sub brow and lateral eyebrow approach.
OBJECTIVES:
 The purpose of this study is to assess intra-operative and post-operative parameters such as pain, scarring, time taken to reach fractured site, surgical field(bleeding).post operative edema after fixation of frontozygomatic suture in zygomaticomaxillary complex fractures using sub brow and lateral eyebrow approach
MATERIALS AND METHOD:
 The study is a comparative study. The  study sample will be derived from the population of patients with zygomaticomaxillarycomplex fractures .Fractures involving frontozygomatic suture region requiring Open Reduction and Internal Fixation who report to the Department of Oral and Maxillofacial Surgery, Adhiparasakthi Dental College and Hospital, Melmaruvathur, Tamil Nadu, India. The patients will be randomly divided into two groups of 10 each. Randomization will be performed by lots in closed envelopes. Group I will comprise of patients treated with sub brow incision. Group II will be treated with lateral eyebrow incision.
SOURCE OF SAMPLE TO BE TAKEN:
 Out patients from the department of Oral and Maxillofacial Surgery at Adhiparasakthi Dental College and Hospital
INCLUSION CRITERIA:
1. Patients who are fit for procedures under general anesthesia between age group of 16 to 50 years will be included ( ASA I and II) 
2. Patients with zygomatico maxillary complex fractures involving the frontozygomatic suture
 
EXCLUSION CRITERIA:
1.Patients who are not willing to participate in the study 
2.Patients unfit for surgery under general anesthesia ASA (III and IV)
3. Patients with zygomatico maxillary complex fractures not involving the frontozygomatic suture 
4. Patients below 16 years of age. 

METHODOLOGY:
 The study sample will be derived from the population of patients with zygomaticomaxillarycomplex fractures. Fractures involving frontozygomatic suture requiring Open Reduction and Internal Fixation who report to the Department of Oral and Maxillofacial Surgery. Diagnosis would be made using the help of CT Facial bones. The patients will be randomly divided into two groups of 10 each. Randomization will be performed by lots in closed envelopes. Patients will be exxplained about the study and informed and a written consent will be obtained from both the patient and his/her attenders. Patients will be admitted under Oral and Maxillofacial Surgery and necessary medications would be administered. Anaesthetic fitness will be obtained.  Extraoral approach will be used to expose the fracture line and an intraoral/extraoral incision will be placed if there is an additional fracture to be managed .The frontozygomatic suture region will be exposed by sub brow Group I . Group Il patients would undergo surgical site exposure by lateral eyebrow incision .Intra operative parameters includes surgical field(bleeding), measured using Fromme’s scale time taken to reach the fractured site will be evaluated.
The Fromme’s scale includes grade’s ranging from 0-5 as described below
Grade 5- Massive uncontrollable bleeding
Grade 4- Bleeding, heavy but controllable, that significantly interferes with dissection
Grade 3- Moderate bleeding that moderately compromises surgical dissection
Grade 2- Moderate bleeding, a nuisance but without interfering with accurate dissection
Grade 1-  Bleeding, so mild it was not even a surgical nuisance
Grade 0 - No bleeding 
. Patients will then be discharged with instructions and post operative medications and asked to report back for further assessment and evaluation pain at lst day, 7th day and 30th day 
Visual Analog scale is a scale that compromises of facial emotions ranging from 0-10
0- no pain
1-3- Mild pain
4-7- moderate and severe pain
7-9- very severe pain
10- worst pain 
 The post operative scarring will be evaluated at 7 day, 30" day and 60" day. (Modified Vancouver scar scale)
The scale includes
Pigmentation
0 = normal
1 = hypo-pigmentation
2 = mixed pigmentation
3 = hyper-pigmentation

Vascularity
0 = normal
1 = pink
2 = red
3 = purple

Pliability

0 = normal

1 = supple-flexible with minimal resistance

2 = yielding giving way to pressure

3 = firm-inflexible, not easily moved, resistant to manual pressure

4 = banding-rope-like tissue that blanches with extension of scar

5 = contracture-permanent shortening of scar producing deformity or distortion

Height
0 = normal-flat
           1 = >0 to 1 mm
           2=>1 to 2 mm
           3 =>2 to 4 mm
           4= >4 mm
 Total- 15

The post operative edema will be evaluated at 1st day, 7th day, 14th day using Facial points  
The time will be measured in seconds using stopwatch




 
Close