| CTRI Number |
CTRI/2025/03/082869 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARATIVE EVALUATION OF THE MODIFIED ARCH BAR AND CONVENTIONAL ERICH ARCH BAR FOR MAXILLOMANDIBULAR FIXATION IN MANDIBULAR FRACTURES. |
|
Scientific Title of Study
|
PHASE II CLINICAL TRIAL COMPARATIVE EVALUATION OF THE MODIFIED ARCH BAR AND CONVENTIONAL ERICH ARCH BAR FOR INTER-MAXILLARY FIXATION IN MANDIBULAR FRACTURES |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
YOGENDRA SINGH THAKUR |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL, RAIPUR |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY
GOVERNMENT DENTAL COLLEGE AND HOSPITAL, RAIPUR, (C.G.) 492001
Raipur
CHHATTISGARH
491995
India |
| Phone |
9770526785 |
| Fax |
|
| Email |
yogendrasinghthakur1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr NAVED KHAN |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL, RAIPUR |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY
GOVERNMENT DENTAL COLLEGE AND HOSPITAL, RAIPUR, (C.G.) 492001
Raipur
CHHATTISGARH
492001
India |
| Phone |
9302823613 |
| Fax |
|
| Email |
naved1977@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
YOGENDRA SINGH THAKUR |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL, RAIPUR, (C.G.) 492001 |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY
GOVERNMENT DENTAL COLLEGE AND HOSPITAL, RAIPUR, (C.G.) 492001
Raipur
CHHATTISGARH
491995
India |
| Phone |
9770526785 |
| Fax |
|
| Email |
yogendrasinghthakur1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yogendra Singh Thakur, Government Dental College Raipur, Chattisgarh 492001 |
|
|
Primary Sponsor
|
| Name |
DR YOGENDRA SINGH THAKUR |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY
GOVERNMENT DENTAL COLLEGE AND HOSPITAL, RAIPUR, (C.G.) 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 |
| DR YOGENDRA SINGH THAKUR |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL, RAIPUR |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY
GOVERNMENT DENTAL COLLEGE AND HOSPITAL, RAIPUR, (C.G.) 492001
Raipur
CHHATTISGARH |
9770526785
yogendrasinghthakur1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOVERMENT DENTAL COLLEGE RAIPUR INSTITUTIONAL ETHICS COMMITEE |
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 |
ERICH ARCH BAR |
CONVENTIONAL ERICH ARCH BAR FOR INTER-MAXILLARY FIXATION IN MANDIBULAR FRACTURES
follow upon 10th,20th,30,and 37th day |
| Intervention |
MODIFIED ARCH BAR |
MODIFIED ARCH BAR FOR INTER-MAXILLARY FIXATION IN MANDIBULAR FRACTURES.
follow upon 10th,20th,30,and 37th day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Maxillomandibular trauma patient with undisplaced fracture.
2. Age group of 18–50 years.
3. Patients under the category of ASA I.
4. Patients who are willing to accept informed consent and are willing to participate in the study with subsequent follow-ups will be included in this study.
5. Patient of good periodontal health.
|
|
| ExclusionCriteria |
|
|
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 modified arch bar is expected to have a better outcome in terms of:-
• reduced time for the procedure
• better oral hygiene
• periodontal health
• and patient acceptance (post-operative pain).
|
10th day,20th day,30 th day, 37th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome of the study is that the modified arch bar provides better intermaxillary fixation stability, preventing the risk of injuries caused by wires, and transmission of blood-born infection due to glove tear than the conventional Erich arch bar |
6 MONTHS |
|
|
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 3 |
|
Date of First Enrollment (India)
|
02/01/2028 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/02/2025 |
| 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 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 - All of the individual participant data collected during the trial, after de-identification.
- 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 [yogendrasinghthakur1@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 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Mandible fractures are common in oral and maxillofacial surgery, often involving the body, angle, and condyle. Maxillomandibular fixation (MMF) is essential for stabilizing fractures and restoring function. Traditional MMF methods, like arch bars, have drawbacks, including tooth damage, poor oral hygiene, and discomfort. Newer alternatives, such as bone-anchored screws and orthodontic devices, offer faster application, increased comfort, and better oral hygiene with fewer complications. A prospective study will compare customized fixation devices to traditional arch bars in 30 patients, focusing on fixation stability, complications, patient satisfaction, and long-term effects, aiming to improve treatment outcomes and patient care |