CTRI Number |
CTRI/2018/05/014101 [Registered on: 25/05/2018] Trial Registered Retrospectively |
Last Modified On: |
25/05/2018 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A study on three different methods of bone fixing in the treatment of lower jaw fractures |
Scientific Title of Study
|
A Comparative study of outcomes of three different bone plating techniques in the treatment of mandibular symphysis or parasymphysis fractures |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
None |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
P Divya Naga Lakshmi |
Designation |
Assistant Professor |
Affiliation |
Vishnu Dental College |
Address |
Department of Oral and maxillofacial Surgery,
Room no. 2
Block no. 3,
Vishnu Dental College, Vishnupur, Bhimavaram
West Godavari ANDHRA PRADESH 534208 India |
Phone |
9640185785 |
Fax |
|
Email |
puvvadadivya87@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Kishore Moturi |
Designation |
Professor and HOD |
Affiliation |
Vishnu Dental College |
Address |
Department of Oral and Maxillofacial Surgery, Room no 2, 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 Kishore Moturi |
Designation |
Professor and HOD |
Affiliation |
Vishnu Dental College |
Address |
Department of Oral and Maxillofacial Surgery, Room no 2, Block 3, Vishnu Dental College, Vishnupur, Bhimavaram
West Godavari ANDHRA PRADESH 534202 India |
Phone |
9849094159 |
Fax |
|
Email |
moturik@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
P Divya Naga Lakshmi |
Address |
Assistant Professor,
Department of Oral and Maxillofacial surgery
Vishnu Dental College, Vishnupur, Bhimavaram |
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 |
P Divya Naga Lakshmi |
Vishnu Dental College |
Department of Oral And Maxillofacial Surgery,
Room no.2
Block no 3,
Vishnupur, Bhimavaram West Godavari ANDHRA PRADESH |
9640185785
puvvadadivya87@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 individual who sustained maxillofacial trauma, with fractures of isolated mandibular symphysis or parasymphysis fractures requiring open reduction and internal fixation, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
2.5mm 6 hole with gap stainless steel locking plate |
High grade medical stainless steel 2.5 mm 6 hole locking plate manufactured by Sirag Surgicals, Chennai.
Plates would remain inside until, any symptomatic indication for removal exists (at least for a period of 6months) |
Comparator Agent |
2.5 mm 4 hole with gap Stainless steel Miniplates |
Two High grade Medical stainless steel miniplates manufactured by Sirag Surgicals, Chennai.
Plates would remain inside until, any symptomatic indication for removal exists (at least for a period of 6months) |
Intervention |
2mm 4 hole 3- Dimensional single stainless steel miniplate |
3 Dimensional single High grade medical stainless steel plate manufactured by Sirag Surgicals, Chennai.
Plates would remain inside until, any symptomatic indication for removal exists (at least for a period of 6months) |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1) Simple fractures of the symphysis or parasymphysis requiring open reduction and internal fixation
2) Patients presenting to the department within 48hrs of injury
3) Patient consenting for the study |
|
ExclusionCriteria |
Details |
1) Subjects with associated comminuted, displaced fractures of other regions of the mandible
2) Severe medically compromised patients and patients on immunosuppressive drugs
3) Patients with gross infection at the site of fracture
4) Edentulous patients
5) Associated midface trauma
6) Patients having neurological deficit or neurological related disorders
7) Severely periodontally compromised patients
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Treatment outcomes like stability of fractured fragments and occlusal stability using three different bone plating techniques |
3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
wound healing or soft tissue dehiscence, vitality of teeth, palpability of plates and radio graphical displacement of fractured fragments |
3 months |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
Phase of Trial
|
Post Marketing Surveillance |
Date of First Enrollment (India)
|
28/11/2017 |
Date of Study Completion (India) |
27/03/2018 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
27/03/2018 |
Estimated Duration of Trial
|
Years="0" Months="3" Days="29" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Not yet published |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
PURPOSE - The purpose of the study is to evaluate outcomes for three different bone plating techniques used in the treatment of mandibular symphysis/ parasymphysis fractures. PATIENTS AND METHODS: 30 patients with isolated and undisplaced mandible fractures were selected who required open reduction and internal fixation were included in the study. Patients were divided in to 3 groups, Group I – 2.5mm locking Stainless Steel plate used, Group II – two 2.5 mm standard miniplates were used and Group III – 2.0 mm 3-D miniplate were used. Patients were evaluated for clinical and radiographic parameters during a 3 month follow-up period and data subjected to statistical analysis. RESULTS: Group I (n=10) had no incidence of complications associated with plating and in group II (n=10) 3 patients had discrepancies in occlusion required IMF during first week after surgery but noticed a good healing of fracture site with no discrepancies in occlusion at 3 month follow-up.2 of the patients had loss of vitality of teeth associated with plating at 3 week follow-up. Patients in group III (n=10) 2 of the patients had discrepancies in occlusion requiring IMF and loss of vitality in 2 patients. Wound dehiscence associated with infection was noticed in 1 patient during 6th postoperative day which healed successfully after local debridement and use of systemic antibiotics. Overall complications had no statistical significance between group II and III, but had significance in comparison with group I. CONCLUSION – The use of 2 miniplates and 3D plates was associated with more postoperative complications than the use of single locking plate at lower border, but all the three techniques produced sufficient stability for healing. |