| CTRI Number |
CTRI/2021/11/038160 [Registered on: 22/11/2021] Trial Registered Prospectively |
| Last Modified On: |
07/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare and evaluate the uses of Erich arch bars, Inter Maxillary Fixation screws and hybrid arch bars in the management of mandibular fractures |
|
Scientific Title of Study
|
To compare and evaluate the efficacy of Erich arch bars, IMF screws and hybrid arch bars in the management of mandibular fractures- Randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Salavadi Revanth Kumar |
| Designation |
Assistant Professor |
| Affiliation |
ESIC Medical College & Hospital |
| Address |
Room No. 208, OPD Block,
Department Of Dentistry,
ESIC Medical College & Hospital,
Sanathnagar, Hyderabad, Telangana
Ravindranagar colony
Habsiguda
Hyderabad
TELANGANA
500038
India |
| Phone |
9989760025 |
| Fax |
|
| Email |
revanthkumar22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Salavadi Revanth Kumar |
| Designation |
Assistant Professor |
| Affiliation |
ESIC Medical College & Hospital |
| Address |
Room No. 208, OPD block
Department of Dentistry
ESIC medical college & hospital
Sanathnagar, Hyderabad
Telangana
Ravindranagar colony
Habsiguda
Hyderabad
TELANGANA
500038
India |
| Phone |
9989760025 |
| Fax |
|
| Email |
revanthkumar22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Salavadi Revanth Kumar |
| Designation |
Assistant Professor |
| Affiliation |
ESIC Medical College & Hospital |
| Address |
Room No. 208, OPD Block,
Department Of Dentistry,
ESIC Medical College & Hospital,
Sanathnagar, Hyderabad, Telangana
Ravindranagar colony
Habsiguda
Hyderabad
TELANGANA
500038
India |
| Phone |
9989760025 |
| Fax |
|
| Email |
revanthkumar22@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical College & Hospital, Sanathnagar, Hyderabad, Telangana |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| Type of Sponsor |
Other [] |
|
|
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 |
| Revanth kumar |
ESIC medical college & hospital |
Room nO.208, OPD Block, Department Of Dentistry, ESIC Medical college & Hospital,
Sanathnagar, Hyderabad
Hyderabad
TELANGANA |
9989760025
revanthkumar22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Erich arc bars |
Single use of Erich arc bars in mandibular fracture for a minimum period of 1 month duration and maximum 3 months duration depending on the clinical necessity |
| Intervention |
Hybrid arch bars |
Single use of Hybrid arch bars in mandibular fracture for a minimum period of 1 month duration and maximum 3 months duration depending on the clinical necessity |
| Comparator Agent |
Intermaxillary fixation screws |
Single use of Intermaxillary fixation screws in mandibular fracture for a minimum period of 1 month duration and maximum 3 months duration depending on the clinical necessity |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with mandibular fractures requiring occlusal correction.
|
|
| ExclusionCriteria |
| Details |
Medically compromised patients
Pts with other associated facial fractures
Age > 65 yrs
Pts who got treatment in other hospitals
Pts not willing to participate in the study.
Pts with bone pathology
Pts with H/O radiation therapy
Edentulous patients.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Occlusion stability, Time taken to apply, Glove perforation. |
Occlusion stability- intraoperatively, 1 week, 4 weeks, 12 weeks.
Time taken to apply- Intraoperatively.
Glove perforation- Intraoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Oral hygiene assessment, mucosal growth, dental injuries.
|
Oral hygiene assessment -Preoperatively, 4 weeks and 12 weeks.
mucosal growth- 4 weeks and 12 weeks.
Dental Injuries - Intraoperatively, Immediate postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
23/11/2021 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
•Maxillofacial trauma involving skeletal and dental components requires treatment to restore normal anatomic function •MaxilloMandibular Fixation is important step in treatment to achieve occlusion •Erich arch bar, IMF screws and Modified arch bar has advantages and disadvantages •To overcome complications, modified arch bar is designed in such a way that screws are placed away from the marginal gingival of teeth without perforating arch bar •Hybrid MMF is another system which combines features of arch bar & IMF screws without compromising arch bar. •Limited research in the literature on hybrid arch bars. So this study is designed to compare hybrid arch bars with erich arch bars and IMF screws in the management of mandibular fractures. |