| CTRI Number |
CTRI/2024/04/065648 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative assessment of efficiency and patient tolerance of hybrid arch bar, Erich’s arch bar and MMF screw placement in treatment of jaw fractures |
|
Scientific Title of Study
|
Comparative assessment of efficiency and patient tolerance of hybrid arch bar, Erich’s arch bar and MMF screw placement in treatment of jaw fractures |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
CSSherwin Samuel |
| Designation |
PG student |
| Affiliation |
Dr. D Y Patil dental college and hospital |
| Address |
Plot 52,
Atlas colony colony,
Mahesh nagar,
Pimpri,
Pune
Department of Oral and Maxillofacial Surgery,
3rd floor,
Dr. D Y Patil dental college and hospital
Sant Tukaram Nagar, Pimpri Colony, Pune, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411 018
India |
| Phone |
08939031237 |
| Fax |
|
| Email |
sherwinsamuel23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kalyani Bhate |
| Designation |
Professor |
| Affiliation |
Dr. D Y Patil dental college and hospital |
| Address |
Plot 52,
Atlas colony colony,
Mahesh nagar,
Pimpri,
Pune
Department of Oral and Maxillofacial surgery,
3 rd floor
Dr. D Y Patil dental college and hospital,
Sant Tukaram Nagar, Pimpri Colony, Pune, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411 018
India |
| Phone |
9822099311 |
| Fax |
|
| Email |
kalyani.bhate@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
CSSherwin Samuel |
| Designation |
PG student |
| Affiliation |
Dr. D Y Patil dental college and hospital |
| Address |
Plot 52,
Atlas colony colony,
Mahesh nagar,
Pimpri,
Pune
Department of Oral and Maxillofacial surgery,
3 rd floor
Dr. D Y Patil dental college and hospital
Sant Tukaram Nagar, Pimpri Colony, Pune, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411 018
India |
| Phone |
08939031237 |
| Fax |
|
| Email |
sherwinsamuel23@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. D Y Patil dental college and hospital |
| Address |
Sant Tukaram Nagar, Pimpri Colony, Pune, Pimpri-Chinchwad, Maharashtra 411018
|
| 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 CSSherwin Samuel |
Dr. D. Y. Patil dental college and hospital |
Department of Oral and Maxillofacial surgery,
3 rd floor
Dr. D Y Patil dental college and hospital
Sant Tukaram Nagar, Pimpri Colony, Pune, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA |
08939031237
8939031237
sherwinsamuel23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| EthicsCommitteeofDr.D.Y.PatilVidyapeeth,Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S02||Fracture of skull and facial bones, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Maxillomandibular fixation |
Erich arch bar during surgery |
| Comparator Agent |
Maxillomandibular fixation |
MMF screws and Hybrid arch bar during surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with maxillofacial fractures requiring maxillomandibular fixation |
|
| ExclusionCriteria |
| Details |
Patients with comminuted fractures of factial bones. parhological fractures, edentulous ridges.
Patients with metabolic disorders, bleeding disorders, history of radiotherapy or chemotherapy |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gingival inflammation |
4 weeks post operative and 5 weeks post operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken for application of MMF appliance |
Day 0 |
| Time taken for removal of MMF appliance |
4 weeks Post op |
| Patient discomfort |
4 weeks post op |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
22/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/04/2024 |
| 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)
|
Open to Recruitment |
| 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
|
A prospective randomized controlled clinical trial to be conducted on 45
patients with maxillofacial fractures requiring maxillomandibular fixation were
split into 3 groups of 15 each. Patients in group A will be treated with Erich
arch bar, patients in group B with MMF screws and patients in group C with
hybrid arch bar. Factors to be assessed are gingival inflammation on day of removal
and 7 days post removal of MMF appliance using modified gingival index, time
taken for placement and removal in minutes and patient discomfort using visual
analog scale. |