| CTRI Number |
CTRI/2025/02/080090 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Self drilling screws with Conventional screws in facial fractures |
|
Scientific Title of Study
|
Comparative Evaluation of Self Drilling Titanium Screw Vs Conventional Screw for Open Reduction and Internal Fixation in Mid Face 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 |
Dr Maitry Negi |
| Designation |
Resident Doctor |
| Affiliation |
Faculty of Dental Science, Dharmsinh Desai University |
| Address |
Department of Oral and Maxillofacial Surgery, Faculty of Dental Science, Dharmsinh
Desai University, College Road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
07487910749 |
| Fax |
|
| Email |
maitrynegi01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hiren Patel |
| Designation |
Professor and Head of the Department |
| Affiliation |
Faculty of Dental Science, Dharmsinh Desai University |
| Address |
Department of Oral and Maxillofacial Surgery, Faculty of Dental Science, Dharmsinh
Desai University, College Road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9426034400 |
| Fax |
|
| Email |
hirenpatel.fods@ddu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maitry Negi |
| Designation |
Resident Doctor |
| Affiliation |
Faculty of Dental Science, Dharmsinh Desai University |
| Address |
Department of Oral and Maxillofacial Surgery, Faculty of Dental Science, Dharmsinh
Desai University, College Road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
07487910749 |
| Fax |
|
| Email |
maitrynegi01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Dental Science, Dharmsinh Desai University, Nadiad,
Kheda
GUJARAT
387001
India |
|
|
Primary Sponsor
|
| Name |
Faculty of Dental Science, Dharmsinh Desai University |
| Address |
Faculty of Dental Science, Dharmsinh Desai University, College road, Nadiad,
Gujarat |
| 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 Maitry Negi |
Faculty of Dental Science, Dharmsinh Desai University |
Department of Oral and
Maxillofacial Surgery, Faculty of
Dental Science, Dharmsinh
Desai University, College Road,
Nadiad
Kheda
GUJARAT |
7487910749
maitrynegi01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Of Faculty Of Dental Science Dharmsinh Desai University |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional screws |
which require pre-drilling or tapping before insertion
|
| Intervention |
Self Drilling screw |
They have a drill bit-like tip, allowing them to drill their own pilot hole as they are screwed into materials like metal, wood, or plastic. This eliminates the need for pre-drilling a hole, making them very convenient and efficient taking 10-15 mins per screw |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both genders in the age group of less than 60 years.
Patients who needs Open Reduction And Internal Fixation (ORIF) in mid face fractures.
Patients who maintain satisfactory oral hygiene and are co-operative.
Patients who could come for regular follow up.
|
|
| ExclusionCriteria |
| Details |
Patient who have any uncontrolled systemic condition that may contraindicate surgery.
Systemic bone diseases such as osteoporosis, osteopenia, osteopetrosis.
Patients under long-term corticosteroid or bisphosphonate therapy
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stability of Fixation |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complication Rate |
2 days, 1 week, 4 week, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 4 |
|
Date of First Enrollment (India)
|
20/02/2025 |
| 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="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
|
This randomized controlled study compares the efficacy and safety of self-drilling titanium screws and conventional screws in managing maxillofacial fractures. Self-drilling titanium screws show better outcomes in terms of stability, reduced surgical time, and fewer complications compared to conventional screws. |