CTRI Number |
CTRI/2021/10/037566 [Registered on: 26/10/2021] Trial Registered Prospectively |
Last Modified On: |
26/10/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia Dentistry Other (Specify) [Complications of surgical apporaches in condylar fracutres of Mandible] |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison of two different surgical operation techniques for lower jaw fractures |
Scientific Title of Study
|
Complications and time required for surgical access with retromandibular transparotid and anteroparotid transmasseteric approaches in management of mandibular condylar fracture: A prospective randomised clinical study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Pareeksit Bagchi |
Designation |
Resident |
Affiliation |
MGM Dental College and Hospital |
Address |
Dept of Oral and Maxillofacial Surgery, 4th Floor MGM Dental College and Hospital Sector 1 Kamothe Navi Mumbai
Raigarh MAHARASHTRA 410209 India |
Phone |
9322190927 |
Fax |
|
Email |
pareeksitbagchi@yahoo.in |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sunil Sidana |
Designation |
Professor |
Affiliation |
MGM Dental College and Hospital |
Address |
Dept of Oral and Maxillofacial Surgery 4th Floor MGM Dental College and Hospital Sector 1 Kamothe Navi Mumbai
Raigarh MAHARASHTRA 410209 India |
Phone |
9820798821 |
Fax |
|
Email |
drsunilsidana@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Sunil Sidana |
Designation |
Professor |
Affiliation |
MGM Dental College and Hospital |
Address |
Dept of Oral and Maxillofacial Surgery 4th Floor MGM Dental College and Hospital Sector 1 Kamothe Navi Mumbai
Raigarh MAHARASHTRA 410209 India |
Phone |
9820798821 |
Fax |
|
Email |
drsunilsidana@gmail.com |
|
Source of Monetary or Material Support
|
Mahatma Gandhi Mission (MGM) dental College and hospital kamothe sector 1 Navi Mumbai 410209 |
|
Primary Sponsor
|
Name |
Dept of Oral and Maxillofacial Surgery |
Address |
MGM Dental College and Hospital Sector 1 Kamothe Navi Mumbai 410209 |
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 Pareeksit Bagchi |
Mahatma Gandhi Mission (MGM)dental College and hospital |
Room number 3 fourth floor department of oral and maxillofacial surgry MGM dental college building MGM Campus MGM Dental College and Hospital Sector 1 Kamothe Navi Mumbai 410209 Raigarh MAHARASHTRA |
9322190927
pareeksitbagchi@yahoo.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Review Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: T888||Other specified complications of surgical and medical care, not elsewhere classified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Anteroparotid Transmasseteric Appraoch |
Group B Comprising of 15 patients with subcondylar fractures of the mandbile will be operated for open reduction and internal fixation with this approach only once intraoperatively. Patient will be followed up for 2 weeks post surgery |
Comparator Agent |
Transparotid Approach |
Group A Comprising of 15 patients with subcondylar fractures of the mandbile will be operated for open reduction and internal fixation with this approach only once intraoperatively. Patient will be followed up for 2 weeks post surgery |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. Participants in the age group of 18 – 60 years.
2. Participants with unilateral/bilateral condylar fractures indicated for open reduction.
3. Participants with unilateral/bilateral condylar fractures along with other concomitant fractures of mandible indicated for open reduction.
4. Participants who have sustained fracture in the past two weeks.
5. Subject willingness to participate in the study. |
|
ExclusionCriteria |
Details |
1. Participants with history of uncontrolled diabetes mellitus, prolonged steroid therapy, compromised immunity and associated bone
pathology.
2. Intracapsular Condylar fracture.
3. Undisplaced fractures of Mandibular Condylar fracture.
4. Patients with high condylar fractures.
5. Patients who have undergone open reduction and internal fixation for condylar fractures previously.
6. Participants with tendency for keloid formation and those with contused lacerated wounds, abrasions or Avulsive soft tissue injuries around the area of extraoral incision. (pre existing scar)
7. Presence of preinjury Facial nerve palsy. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Complications and time required for each approach |
Complications will be evaluated at post operative day 1 day 7 1 month and 2 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
time required for each approach |
Intraoperatively after incision till exposure of fracture |
Post operative swelling |
At 1 weeks and 2 weeks postoperatively |
Parotid fistula |
At 1 week and 2 weeks |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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 4 |
Date of First Enrollment (India)
|
01/11/2021 |
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="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
Not applicable |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
25 to 45% of all the mandibular fractures are mandibular condylar fractures. The reason for the high incidence of condylar fractures is the peculiar anatomy of the mandible which ensures dissipation of forces along the bone allowing the weakest part of the condylar neck to fracture, thus preventing transfer of forces to the Cranium. Optimal osteosynthesis of such a fracture can be attained only by rigid internal ï¬xation after anatomic reduction. Studies by Ellis and Throckmorton published in 2000 conclude that patients who had ORIF had better restitution of condyle position and reinforcement of their fractured condylar processes. Patients who underwent closed reduction had displacement of the condylar process in the coronal plane, which persisted for up to 1 year, and had a signiï¬cant shortening of the mandibular ramus on the fractured side though bite forces did not show any signiï¬cant difference. To get direct vision of the fractured ends and mobilization of the displaced segments it is essential to gain complete exposure of the surgical field. Distance between the incision line and fracture level often necessitates excessive retraction of tissues resulting in nerve injuries and tissue damage. Appropriate choice of surgical approach gains importance in reducing the post operative complications especially while dealing with less accessible fracture sites like the sub-condylar region. Conventional exposure techniques like preauricular, submandibular, intraoral, and retromandibular incisions are the most commonly used access routes for the ORIF of a subcondylar fracture as endoscopes are yet to gain popularity in India. The intraoral route although desirable as it avoids facial scarring provides limited exposure for manipulation and fixation of the fracture site. Therefore the extra oral route is the most commonly selected one. However, each of these incision have varying degrees of complications reported due to the proximity to two vital structures namely the facial nerve and the parotid gland. The retro-mandibular approach described by Hinds and Girroti in1967 has been the most popular, as it involves a minimal working distance between the incision and the fracture. While using a retromandibular incision, the approach to the fracture site can be either through the parotid gland, as in the retromandibular transparotid approach, or the parotid maybe bypassed by use of the retromandibular transmasseteric anterior parotid (TMAP) approach. Here, we will try to compare two most popular variations of retromandibular approach that is – retromandibular transparotid approach; retromandibular anteroparotid transmasseteric approach. The purpose of this study will be to compare the time required to expose the condylar fracture site and also the rate of complications encountered on using different incisions to access the fracture site for the open reduction and internal ï¬xation of condylar fractures. The parameters evaluated are: time required to expose the condylar fracture site and the occurrence of salivary ï¬stula, infection, and injuries to the seventh cranial nerve.
Clinical Significance of the Study: This study will help in decision making regarding the choice of approach between the Retromandibular Transparotid and Anteroparotid Transmasseteric approach based on the ease of surgical access and incidence of complications |