| CTRI Number |
CTRI/2024/11/076453 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
27/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Transconjunctival Approach for the Management of Fractures involving Infraorbital Rim: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Comparison of the Efficacy of Transconjunctival Approach without Lateral Canthotomy with Infraorbital Approach for the Management of Fractures involving Infraorbital Rim: A Randomized Controlled Trial |
| 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 Aishwarya Babhulkar |
| Designation |
Post graduate student |
| Affiliation |
Geetanjali Dental and Research Insitute |
| Address |
Department of Oral and Maxillofacial Surgery, Geetanjali Dental & Research Institute, Udaipur
Udaipur
RAJASTHAN
313002
India |
| Phone |
8888751198 |
| Fax |
|
| Email |
aishwaryababhulkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shallu Bansal |
| Designation |
Professor & Head |
| Affiliation |
Geetanjali Dental and Research Insitute |
| Address |
Department of Oral and Maxillofacial Surgery, Geetanjali Dental & Research Institute, Udaipur
Udaipur
RAJASTHAN
313002
India |
| Phone |
9116155666 |
| Fax |
|
| Email |
drshallu23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shallu Bansal |
| Designation |
Professor & Head |
| Affiliation |
Geetanjali Dental and Research Insitute |
| Address |
Department of Oral and Maxillofacial Surgery, Geetanjali Dental & Research Institute, Udaipur
RAJASTHAN
313002
India |
| Phone |
9116155666 |
| Fax |
|
| Email |
drshallu23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Geetanjali Dental & Research Institute, Udaipur |
|
|
Primary Sponsor
|
| Name |
Geetanjali Dental & Research Institute |
| Address |
Department of Oral & Maxillofacial Surgery. Geetanjali Dental & Research Institute, Manva Kheda, Eklingpura, Udaipur, Rajasthan, 313001 |
| Type of Sponsor |
Research institution |
|
|
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 Shallu Bansal |
Department of Oral & Maxillofacial Surgery Geetanjali Dental & Research Institute, Udaipur |
Department of Oral & Maxillofacial Surgery Geetanjali Dental & Research Institute, Geetanjali university Udaipur
Udaipur
RAJASTHAN |
9116155666
drshallu23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human research ethic committee of Geetanjali university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T889||Complication of surgical and medical care, unspecified, (2) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, (3) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Infra orbital approach for the management of infra orbital rim fracture |
infra orbital approach is one of the most preferred approach for the management of infra orbital rim fracture and it is compared with transconjunctival approach without canthotomy in this study |
| Intervention |
Transconjunctival approach for management of infra orbital rim fracture |
transconjunctival approach without lateral canthotomy is used for the management of infra orbital rim fracture in the study group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between age of 18-70 years of both genders.
2. Patients with clinical and radiological evidence of
infraorbital rim fractures which requires open
reduction and internal fixation.
3. Healthy patients falling under ASA I and ASA II
4. Subjects able and willing to provide written
informed consent and compliant with study procedure. |
|
| ExclusionCriteria |
| Details |
1. Patients with contused or lacerated wound in lower eyelid.
2. Patients with open globe injury or hyphema, conjunctival pathology,
ocular surface or glaucoma.
3. Patients having any systemic or local immunodeficiency.
4. Patients with osteoporosis and osteopetrosis
5. Patients with medical co-morbidities
6. Having any blood coagulation impairment.
7. Have been suffering with uncontrolled diabetes or other systemic
diseases. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
INTRA OPERATIVE PARAMETERS
1) Surgical time to expose the fracture site
2) Surgeon’s satisfaction for the stability of plate
POST OPERATIVE PARAMETERS
1) Pain
2) Eyelid oedema
3) Ecchymosis
4) Epiphora
5) Scar
|
INTRA OPERATIVE PARAMETERS
1) Surgical time to expose the fracture site
2) Surgeon’s satisfaction for the stability of plate
POST OPERATIVE PARAMETERS
1) Pain on 3rd day, 7th day, 15th day and 1 month
2) Eyelid oedema on 3rd day, 7th day, 15th day and 1 month
3) Ecchymosis on 3rd day, 7th day, 15th day and 1 month
4) Epiphora on 3rd day, 7th day, 15th day and 1 month
5) Scar on 3rd day, 7th day, 15th day and 1 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
POST OPERATIVE PARAMETERS
• Ectropion
• Entropion
• Infection
• Paresthesia/neurosensory involvement
• Malunion/nonunion/delayed union
• Exposure of plates/screws
|
POST OPERATIVE PARAMETERS
• Ectropion on 3rd day, 7th day, 15th day and 1 month
• Entropion on 3rd day, 7th day, 15th day and 1 month
• Infection on 3rd day, 7th day, 15th day and 1 month
• Paresthesia/neurosensory involvement on 3rd day, 7th day, 15th day
and 1 month
• Malunion/nonunion/delayed union on 3rd day, 7th day, 15th day and 1
month
• Exposure of plates/screws on 3rd day, 7th day, 15th day and 1 month
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
14/11/2024 |
| 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
|
Facial injuries such as zygomaticomaxillary complex fractures, Lefort II fractures and orbital fractures may involve the fracture of infraorbital rim. There are varieties of surgical approaches to the infraorbital rim exists and broadly they can be categories as transcutaneous and transconjunctival approach. Transcutaneous approach are further divided as infraciliary incision also known as sub ciliary incision, mid lower eyelid or sub tarsal and infraorbital incisions. These approaches leave behind a scar which may be cosmetically disfiguring at times. An alternate method that avoids the cutaneous scar with adequate exposure is, the use of a transconjunctival incision placed through the conjunctiva. Bourquett described this approach, however it was Tessier who popularized it. The enthusiasts of this approach used it primarily for correction of congenital anomalies of the orbit. McCord and Moses popularized the use of transconjunctival incision for traumatic deformities of the orbit coupled with lateral canthotomy. This allowed the lower eyelid to swing downwards widely, providing adequate exposure of the orbital floor. The sub ciliary incision is made 2mm caudal to the cilial line. The sub tarsal incision placed parallel to the ciliary margin just caudal to the tarsus. The infraorbital incision is designed to lie in a skin crease at the level of the bony orbital margin. Although it may seem that the difference lies only at the level of the incision from the ciliary margin, the anatomy of the region and the plane of dissection also influence the final esthetic result. Complications have also been cited as related to a particular incision used. Although transconjunctival approach is having its own list of complications but it is esthetically pleasing as compared to infraorbital approach. Many authors used an additional lateral canthotomy to provide better access to infraorbital rim and orbital floor. Lorenz et al popularized that there is no need of lateral canthotomy to expose orbital floor and orbital rim.Many studies are available regarding comparison of transconjunctival approach with lateral canthotomy to infraorbital approach. But there is a scarcity of literature regarding transconjunctival approach without canthotomy to infraorbital approach. So the purpose of the present study is to compare the infraorbital approach with transconjunctival approach without lateral canthotomy for the management of fractures involving the infra orbital rim. |