| CTRI Number |
CTRI/2018/05/014292 [Registered on: 31/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
24/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on treatment of lower jaw fractures using two different bone fixing techniques |
|
Scientific Title of Study
|
A Comparative Study of Outcome of Treatment Using Stainless Steel 2mm 6 hole Double Y Locking plate versus 2.5mm 6 hole Straight Locking plate in the Management of Parasymphysis Fractures of Mandible |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| None |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kishore Moturi |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Oral and Maxillofacial Surgery
Block 3
Vishnu Dental College
Vishnupur
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9849094159 |
| Fax |
|
| Email |
moturik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kishore Moturi |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Oral and Maxillofacial Surgery
Block 3
Vishnu Dental College
Vishnupur
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9849094159 |
| Fax |
|
| Email |
moturik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T Mounika |
| Designation |
Post graduate student |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Oral and Maxillofacial Surgery
Block 3
Vishnu Dental College
Vishnupur
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9885343220 |
| Fax |
|
| Email |
mounikadentist@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr T Mounika |
| Address |
Post Graduate student,
Room no 2
Block 3
Department of Oral and Maxillofacial Surgery
Vishnu Dental College
Vishnupur
Bhimavaram |
| Type of Sponsor |
Other [Self funded] |
|
|
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 T Mounika |
Vishnu Dental College |
Room No 2
Block 3
Vishnupur
Bhimavaram
West Godavari
ANDHRA PRADESH |
9885343220
mounikadentist@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Vishnu Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
An otherwise healthy patient who sustained parasymphysis fractures of the mandible without any other associated fractures of the face, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
2.5 mm 6 hole Double Y Locking stainless steel plate |
High grade medical stainless steel 6 hole Double Y Locking plate manufactured by Sirag Surgicals, Chennai |
| Comparator Agent |
2.5 mm stainless steel 6 hole with gap straight locking plate |
High grade medical stainless steel 6 hole with gap 2.5mm locking plate manufactured by Sirag Surgicals, Chennai |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Fractures of the Parasymphysis requiring open reduction and internal fixation
2) Patients presenting to the department within 48 hours of injury
3) Patients consenting for the study |
|
| ExclusionCriteria |
| Details |
1) Subjects with associated comminuted fractures of other regions of mandible and maxilla
2) ASA grade III and patients on immunosuppressive drugs
3) Patients with gross infection at the site of fracture
4) Edentulous patients |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical and Radiographic evaluation of stability of fractured fragments |
3 weeks, 1 month, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Vitality of teeth
Mobility of fractured fragments
Palpability of plates
Wound dehiscence |
3 months |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
02/03/2016 |
| Date of Study Completion (India) |
27/06/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="25" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not published till date |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim : To evaluate outcomes for two different bone plating techniques, a stainless steel locking 2mm 6 hole with gap double Y shaped plate and a stainless steel locking 2.5mm 6 hole with gap straight plate in the management of parasymphysis fractures of the mandible Objective: To evaluate the intraoperative time taken for fixation of double Y locking plate and straight locking plate, To know the treatment outcomes like stability of fractured fragments and occlusal stability following fixation with the two plating systems, to check for complications associated with the fracture fixation and to analyse the advantages of one over the other Methodology: 10 patients with isolated mandibular parasymphysis fractures were randomly divided into 2 groups, Group I were treated with 2mm stainless steel 6 hole with gap Double Y locking plate secured with 2x8mm screws and Group II with 2.5 mm Stainless steel 6 hole with gap staring hot locking plate secured with 2.5 x 8mm screws. Patients were evaluated for clinical and radiographic parameters during the 3 month follow up period. Later the data subjected to statistical analysis Results : Data analysis showed that duration of requirement for intermaxillary fixation was more in group 2 (20%). Wound dehiscence (20%) and iatrogenic tooth root damage (80%) was more in group 1. Intraoperative time taken was less for group 1 (22.4 minutes) and group 2 (35.6 minutes). Conclusion: The use of a single locking plate at lower border had fewer complications of iatrogenic tooth root damage, wound dehiscence and plate exposure, but duration of intermaxillary fixation increased. The two fixation techniques showed sufficient stability for healing with no statistically significant difference. |