| CTRI Number |
CTRI/2023/09/057215 [Registered on: 01/09/2023] Trial Registered Prospectively |
| Last Modified On: |
25/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of improvement in bite forces in patients with lower jaw fractures between two different types of plating methods. |
|
Scientific Title of Study
|
Comparative assessment of improvement in masticatory efficiency in patients with anterior mandibular fractures treated with four-hole versus six-hole mini plate fixation. A pilot randomized control trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PRUTHVI ATUL PARLIKAR |
| Designation |
POST GRADUATE JUNIOR RESIDENT - ACADEMIC |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR |
| Address |
Department of Dentistry
C-Block, Ground Floor,
ALL INDIA INSTITUTE OF MEDICAL SCIENCES
G. E. Road, Tatibandh,
Raipur, Chhattisgarh.
Raipur
CHHATTISGARH
492099
India |
| Phone |
9820107121 |
| Fax |
|
| Email |
pruthvi.a.parlikar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PRUTHVI ATUL PARLIKAR |
| Designation |
POST GRADUATE JUNIOR RESIDENT - ACADEMIC |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR |
| Address |
Department of Dentistry
C-Block, Ground Floor,
ALL INDIA INSTITUTE OF MEDICAL SCIENCES
G. E. Road, Tatibandh,
Raipur, Chhattisgarh.
Raipur
CHHATTISGARH
492099
India |
| Phone |
9820107121 |
| Fax |
|
| Email |
pruthvi.a.parlikar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRUTHVI ATUL PARLIKAR |
| Designation |
POST GRADUATE JUNIOR RESIDENT - ACADEMIC |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR |
| Address |
Department of Dentistry
C-Block, Ground Floor,
ALL INDIA INSTITUTE OF MEDICAL SCIENCES
G. E. Road, Tatibandh,
Raipur, Chhattisgarh.
Raipur
CHHATTISGARH
492099
India |
| Phone |
9820107121 |
| Fax |
|
| Email |
pruthvi.a.parlikar@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES
G. E. Road, Tatibandh,
Raipur, Chhattisgarh.
Pin - 492099 |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR CG |
| Address |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES
G. E. Road, Tatibandh,
Raipur, Chhattisgarh.
Pin - 492099 |
| 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 Manish J Raghani |
All India Institute of Medical Sciences |
C block, Ground floor, AIIMS Raipur, Tatibandh, GE road, Raipur
Raipur
CHHATTISGARH |
9691562656
drmanishraghani@aiimsraipur.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR (CHHATTISGARH) |
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 |
Use of 4 hole mini plate for fracture mandible |
Use of 4 hole mini plate at the lower border of the mandible for open reduction and internal fixation of mandibular anterior fracture. The duration of surgery would be one hour. |
| Intervention |
Use of 6 hole mini plate for fracture mandible |
Use of 6 hole mini plate at the lower border of the mandible for open reduction and internal fixation of mandibular anterior fracture. The duration of surgery would be one hour. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 14 years of age.
Anterior mandible fracture |
|
| ExclusionCriteria |
| Details |
Comminuted/ Infected fractures
Edentulous patients
Fractures involving the maxilla, and other sites of the mandible.
Dentoalveolar fractures which may potentially affect the bite force. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bite Force |
24 hours 1 week 2 weeks & 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain
Occlusion
Swelling
Stability of fracture segments |
24 hours 1 week 2 weeks & 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
09/09/2023 |
| 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="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 - NO
|
|
Brief Summary
|
The mandible is the second most common fractured bone over the facial region after the nose. Road traffic accidents, assaults, and falls from height are common causes of mandibular fractures. Of about 15.1% of reported cases of anterior mandibular fractures, symphysis and parasymphysis fractures account for 2.85% and 12.16%, respectively. A fractured mandible undergoes compression, tension, and torsion due to different muscle forces. Mandibular fracture treatment aims to restore anatomical form and function and re-establish the occlusion, thereby improving the bite force. According to AO (Arbeitsgemeinschaft für Osteosynthesefragen), sufficient internal fixation hardware must be applied to resist the maximum forces of mastication. Recommendations for the amount of fixation hardware necessary to treat fractures of the mandible vary widely—the size of plates (thickness, length, number of holes). The diameter and length of screws, and the number of plates used for anterior mandible fractures differ from surgeon to surgeon. Measuring bite force is an excellent assessment criterion for restoring bony architecture and healing of masticatory soft tissue. Champy and colleagues advocated a modification of Michelet’s miniplate osteosynthesis technique and described ideal lines of osteosynthesis. A standard protocol of osteosynthesis is to use two 4-hole mini plates in anterior inter-foraminal fractures. One at the tension zone and one at the compression zone. Disadvantages of miniplate usage include chances of buccolingual splaying and gap formation at the inferior border. Our study plans to assess the bite force primarily along with pain, swelling, stability and buccolingual splaying if one 4-hole plate was to be placed subapically and a 6-hole mini plate was placed at the inferior border. |