| CTRI Number |
CTRI/2024/11/076806 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of twinfork plate in management of posterior mandible |
|
Scientific Title of Study
|
Versatality of Twin fork plate in the management of mandibular 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 |
Aishwarya Swaminathan |
| Designation |
PG student |
| Affiliation |
Sree Balaji Dental College and Hospitals |
| Address |
Sree Balaji Dental College and Hospitals
Department of Oral and Maxillofacial surgery, Room No.3
Velachery Main Road , Narayanapuram Pallikaranai
Chennai
TAMIL NADU
600100
India |
| Phone |
07358011545 |
| Fax |
|
| Email |
aishuswami27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijay Ebenezer |
| Designation |
Professor and Head of the Department |
| Affiliation |
Sree Balaji Dental College and Hospitals |
| Address |
Sree Balaji Dental College and Hospitals,
Department of Oral and Maxillofacial surgery, Room No.3
Velachery Main Road , Narayanapuram Pallikaranai
Chennai
TAMIL NADU
600100
India |
| Phone |
9840136328 |
| Fax |
|
| Email |
drvijayomfs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aishwarya Swaminathan |
| Designation |
PG student |
| Affiliation |
Sree Balaji Dental College and Hospitals |
| Address |
Sree Balaji Dental College and Hospitals,
Department of Oral and Maxillofacial surgery, Room
No.3,
Velachery Mainroad, Narayanapuram Pallikarani.
Chennai
TAMIL NADU
600100
India |
| Phone |
07358011545 |
| Fax |
|
| Email |
aishuswami27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Aishwarya Swaminathan
Sree Balaji Dental College and Hospitals,
VELACHERY MAIN ROAD, NARAYANAPURAM, PALLIKARANAI, CHENNAI - 600 100 State |
|
|
Primary Sponsor
|
| Name |
Dr Aishwarya Swaminathan |
| Address |
Sree Balaji Dental College and Hospitals,
Department of Oral and Maxillofacial surgery,
Room No. 3
Velachery Mainroad, Narayanapuram, Pallikaranai, Chennai 600100 |
| Type of Sponsor |
Other [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 Aishwarya Swaminathan |
Sree Balaji Dental College and Hospitals |
Sree Balaji Dental College and Hospitals, Department of Oral and Maxillofacial Surgery, Room No. 3,Velachery mainroad, Narayanapuram, Pallikaranai, Chennai 600 100
Chennai
TAMIL NADU |
07358011545
aishuswami27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sree Balaji Dental College and Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Twin fork plate |
1. Twin fork plate,Titanium Grade II, S.S 316
2. 2.0 mm twin fork titanium mini plate (3x3x3 holes)
3. Length of each arm 7.96 mm
4. Distance between two arms 8.94 mm
5. Duration- 1 week, 4 weeks, 12 weeks, 24 week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient who give consent to participate in the study
2 Patient who had fracture involving parasymphysis or body with displacement
3 Patient with fracture line passing on or near the mental canal
4 Patient with CT scan were included in the study |
|
| ExclusionCriteria |
| Details |
• Infected fracture site or wound.
• Presence of osseous pathology.
• Patients unfit for undergoing treatment under general anaesthesia.
• Patients with Lukemia, severe anaemia, bleeding disorders
• Patients undergoing Radiotherapy or Chemotherapy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Immediate fracture reduction
Post operative occlusion and function
Surgical wound healing and scarring
Neurosensory disturbances
|
1st week
4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Post operative Occlusion
2. Post operative reduction of fracture & bone formation
3.Persistant Neurosensory disturbances
4. Surgical wound dehiscence
|
12 weeks
24 weeks |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
29/11/2024 |
| 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
|
The management of mandibular parasymphysis fractures requires stability and effective fixation for optimal healing. The twin fork plate has emerged as a versatile option in the treatment of these fractures. This study explores the versatility, mechanical stability, and clinical outcomes associated with the use of twin fork plates in mandibular parasymphysis fractures. A cohort of patients with parasymphysis fractures treated with twin fork plates was analyzed, focusing on parameters such as ease of plate adaptation, surgical approach, healing time, and post-operative complications.
Results showed that the twin fork plate provided sufficient rigidity and stability, allowing for favorable bone healing and minimal complications. Its design, with dual forks providing multi-directional fixation, offers an advantage in aligning fracture segments and maintaining structural integrity. The study concludes that the twin fork plate is a reliable and versatile method for treating mandibular parasymphysis fractures, with favorable outcomes in terms of fracture stability, ease of use, and patient recovery. Further research with larger sample sizes is recommended to confirm these findings and explore long-term outcomes. |