| CTRI Number |
CTRI/2025/08/092565 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Two Screw Placement Methods in Jaw Fracture Surgery Using Plates for Bone Fixation |
|
Scientific Title of Study
|
Comparative efficacy of miniplate fixation with centric versus eccentric screw placement in open reduction and internal fixation of mandibular fractures: A randomized controlled 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 |
ANKIT KUMAR |
| Designation |
Post graduate student |
| Affiliation |
kothiwal dental college |
| Address |
Kothiwal Dental College, Mora Mustkeen,Kanth road ,Moradabad ,pin-244001
Mora Mustkeen,Kanth road ,Moradabad ,pin-244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
09570587471 |
| Fax |
|
| Email |
Ankitkumarsuman.12345@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Verma |
| Designation |
Professor |
| Affiliation |
kothiwal dental college |
| Address |
ROOM NO.-02 Kothiwal Dental College, Mora Mustkeen,Kanth road ,Moradabad ,pin-244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9736565635 |
| Fax |
|
| Email |
gauravjournals107@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANKIT KUMAR |
| Designation |
Post graduate student |
| Affiliation |
kothiwal dental college |
| Address |
Kothiwal Dental College, Mora Mustkeen,Kanth road ,Moradabad ,pin-244001
Mora Mustkeen,Kanth road ,Moradabad ,pin-244001
UTTAR PRADESH
244001
India |
| Phone |
09570587471 |
| Fax |
|
| Email |
Ankitkumarsuman.12345@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kothiwal Dental College |
| Address |
Mora Mustkeen,Kanth road ,Moradabad ,pin-244001 |
| 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 |
| ANKIT KUMAR |
kothiwal dental college |
Mora Mustkeen,Kanth road ,Moradabad ,pin-244001
Moradabad
UTTAR PRADESH |
09570587471
Ankitkumarsuman.12345@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Review Board (IERB) KOTHIWAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patient with trauma to the isolated symphysis or parasymphysis fracture of mandible |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
centric screw placement |
the placement of screw is in centric or eccentric during miniplate fixation |
| Intervention |
eccentric screw placement |
the placement of screw is in centric or eccentric during miniplate fixation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients 18–55 years with isolated mandibular symphysis or parasymphysis fractures.
Presence of occlusal disturbance due to the fracture.
Patients willing to participate and provide written informed consent. |
|
| ExclusionCriteria |
| Details |
Pediatric patients, pregnant women, or lactating mothers.
Medically compromised individuals who are at high surgical risk.
Patients unable to attend postoperative follow-ups for at least 3 months. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Assessment of stability of fixation as evaluated by stability of occlusion at 7th, 14th, 21st, and 28th post-op day.
2. Assessment of better bone healing as evaluated by recording bite force using a calibrated digital bite force meter at 7th, 14th, 21st, and 28th post-operative day.
Secondary |
1. Assessment of stability of fixation as evaluated by stability of occlusion at 7th, 14th, 21st, and 28th post-op day.
2. Assessment of better bone healing as evaluated by recording bite force using a calibrated digital bite force meter at 7th, 14th, 21st, and 28th post-operative day.
Secondary |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| - To compare the rate of complications with either technique of treatment. |
at 7th, 14th, 21st, and 28th post-operative day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This randomized controlled trial aims to evaluate and compare the efficacy of miniplate fixation using centric versus eccentric screw placement in the treatment of mandibular symphysis and parasymphysis fractures. The study focuses on assessing fixation strength, occlusal stability, bone healing through bite force measurement, and postoperative complications. Thirty patients will be randomly assigned to two groups. The surgical technique, outcomes, and follow-up evaluations are systematically planned. The hypothesis is that eccentric screw placement may enhance fracture stability by generating interfragmentary compression. The study aims to improve surgical outcomes and provide evidence-based recommendations for mandibular fracture management. |