| CTRI Number |
CTRI/2024/12/078576 [Registered on: 26/12/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative Assessment of Closed versus Open (Transparotid) Treatment in Managing Unilateral Condylar Neck or Subcondylar Fractures, with or without Parasymphysis Involvement: A Randomized Clinical Study |
|
Scientific Title of Study
|
A COMPARATIVE EVALUATION OF CLOSED AND OPEN (TRANSPAROTID) TREATMENT IN THE MANAGEMENT OF UNILATERAL CONDYLAR NECK OR SUBCONDYLAR FRACTURES WITH OR WITHOUT PARASYMPHYSIS FRACTURE: RANDOMIZED CLINICAL STUDY. |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivam Shukla |
| Designation |
Post Graduate student |
| Affiliation |
Government Dental college Raipur |
| Address |
Government Dental College, Raipur, near Maarhi maata mandir Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
7208010257 |
| Fax |
|
| Email |
shivamshukla847@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Biswajit Mishra |
| Designation |
Head Of Department, Department of Oral and Maxillofacial Surgery |
| Affiliation |
Government Dental college Raipur |
| Address |
Government Dental College, Raipur, near Maarhi maata mandir Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
|
| Fax |
|
| Email |
mishra.biswajit08@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivam Shukla |
| Designation |
Post Graduate student |
| Affiliation |
Government Dental college Raipur |
| Address |
Government Dental College, Raipur, near Maarhi maata mandir Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
7208010257 |
| Fax |
|
| Email |
shivamshukla847@gmail.com |
|
|
Source of Monetary or Material Support
|
| shivam shukla , Government dental college Raipur 492001 Chattisgarh India |
|
|
Primary Sponsor
|
| Name |
Shivam Shukla |
| Address |
Government dental college raipur chattisgarh 492001 |
| 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 |
| DrShivam Shukla |
Goverment Dental College Raipur |
Department of oral and maxillofacial surgery room no 10
Raipur
CHHATTISGARH |
7208010257
shivamshukla847@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government dental college Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S026||Fracture of mandible, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
closed reduction of condylar fracture through intermaxillary fracture |
comparisson of condylar fracture with open and closed reduction for 18 months |
| Intervention |
open reduction of condylar fracture through transparotid approach |
COMPARISON BETWEEN OPEN FRACTURE REDUCTION AND CLOSED FRACTURE REDUCTION FOR 18 MONTHS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient aged more than 18 years.
2. Patient with unilateral condylar fracture with or without parasymphysis fracture.
3. In the posteroanterior aspect of the mandible, the degree of deviation between the condylar fragment and the ascending ramus is between 10° and 45°, either laterally or medially, with a vertical ramus height shortening of 2–15 mm.
4. The patient must have a good complement of teeth especially posterior teeth.
5. Patient should give consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Previous history of temporomandibular joint dysfunction.
2. Severe pretraumatic dysgnathia.
3. Patient with condylar head fracture.
4. Insufficient dentition to reproduce normal occlusion.
5. All medically compromised patients.
6. Associated midface fractures.
7. Pregnant women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The present study will evaluate and compare the management of condylar fracture with ORIF through transparotid approach and CRMMF.
This study will help in identifying treatment with less pain, discomfort and less facial asymmetry
|
6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
|  The study result will be helpful in clinical application of condylar fractures management and can also be used for further research |
6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
04/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shivamshukla847@gmail.com].
- For how long will this data be available start date provided 01-01-2025 and end date provided 31-12-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
To evaluate and compare closed and open (transparotid) treatment in the management of unilateral condylar neck or subcondylar fractures with or without parasymphysis fracture. Two groups of 12 Patients each requiring treatment condylar fracture and those who are willing to participate and have agreed to postoperative follow-up will be included in the study. Study population include 24 patients with unilateral condylar fracture. The study design involves treating the group A patient with arch bar and intermaxillary fixation alone for 4 weeks and group 2 patient with implant plates surgically. Follow up of 1st, 3rd and 6th month. Key parameters includes maximal mouth opening, pain while mouth opening & anatomical ramus height shortening. By comparing the outcomes between the two groups, the study aims to provide treatment with less pain, discomfort and less facial asymmetry. The study result will be helpful in clinical application of condylar fractures management and can also be used for further researc |