| CTRI Number |
CTRI/2025/07/091011 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Intermaxillary fixation using a solitary wire. |
|
Scientific Title of Study
|
Evaluation of intermaxillary fixation using a solitary wire versus IVY eyelet - A prospective clinical study. |
| Trial Acronym |
Intermaxillary fixation |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M B V Spoorthi |
| Designation |
Post graduate |
| Affiliation |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Anil Neerukonda Institute of Dental Sciences
Sangivalasa
Pin code -531162
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
9642190720 |
| Fax |
|
| Email |
vathsalayaspoorthi362@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V V R Murthy |
| Designation |
Professor |
| Affiliation |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Anil Neerukonda Institute of Dental Sciences
Sangivalasa
Pin code -531162
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
9849598601 |
| Fax |
|
| Email |
murthymaxfac@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr I Naga Malleswararao |
| Designation |
Professor |
| Affiliation |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Anil Neerukonda Institute of Dental Sciences
Sangivalasa
Pin code -531162
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
9618170810 |
| Fax |
|
| Email |
mall.maxface@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anil Neerukonda Institute of Dental Sciences
Visakhapatnam
Andhra Pradesh
Pin code : 531163 |
|
|
Primary Sponsor
|
| Name |
M B V Spoorthi |
| Address |
Anil Neerukonda Institute of Dental Sciences
Sangivalasa
Pin code -531162 |
| 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 M B V Spoorthi |
Anil Neerukonda Institute of Dental Sciences |
Anil Neerukonda Institute of Dental Sciences
Sangivalasa
Pin code -531162
Visakhapatnam
ANDHRA PRADESH |
9642190720
vathsalayaspoorthi362@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics commitee-ANIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S024||Fracture of malar, maxillary and zygoma bones, (2) ICD-10 Condition: S026||Fracture of mandible, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
IVY eyelet
1 week |
IVY eyelet wiring technique
for 1 week |
| Intervention |
Solitary Wiring Technique vs IVY eye let Wiring Technique. |
Intermaxillary Fixation using Solitary wire and IVY eyelet wiring.
1 week |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients with permanent dentition
fractures invoving occlusal derangement |
|
| ExclusionCriteria |
| Details |
Patients with history of seizures
Patients with history of gag reflex |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The wiring techniques may consume significant amount of time intraoperatively which would warrant for identifying or introducing a wiring technique which relatively simple to learn and execute in order to save intraoperative time.
|
1 Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| intraoperative time |
1 week |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
28/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/07/2025 |
| 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 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
|
Wiring techniques are crucial in the outcome of any surgery involving occlusal stability. These existing wiring techniques have significant learning curve to master the skill, it is crucial to understand the complexity involved in any wiring technique. The wiring techniques may consume significant amount of time intraoperatively which would warrant for identifying or introducing a wiring technique which relatively simple to learn and execute in order to save intraoperative time. The current study aims to test one such simple wiring technique perceived to be simple against one of the standard wiring techniques used routinely. |