| CTRI Number |
CTRI/2022/07/043839 [Registered on: 08/07/2022] Trial Registered Prospectively |
| Last Modified On: |
07/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of bone supported EZY arch bars, Intermaxillary Fixation Screws and Conventional Erich arch bar in Maxillo-Mandibular fixation- A Randomised Control Study |
|
Scientific Title of Study
|
Comparison of bone supported arch bars, Intermaxillary Fixation Screws and Conventional arch bar in Maxillo-Mandibular fixation- A Randomised Control Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Acchuthakrishnan K A |
| Designation |
Post graduate student |
| Affiliation |
Karpaga Vinayaga Institute Of Dental Sciences |
| Address |
Department of Oral And Maxillofacial Surgery, Karpaga Vinayaga Institute of Dental Sciences, Gst Road, Palayanoor Post, Chinnakolambakkam Chengalpattu-603308
Pathy Villa, 23 First Cross, Pasumpon Nagar,Karaikal, Karaikal Puducherry- 609602
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
7904307597 |
| Fax |
|
| Email |
acchu7.ak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Karthikeyan G R |
| Designation |
Professor |
| Affiliation |
Karpaga Vinayaga Institute of Dental Sciences |
| Address |
Department of Oral And Maxillofacial Surgery, Karpaga Vinayaga Institute of Dental Sciences, Gst Road, Palayanoor Post, Chinnakolambakkam Chengalpattu-603308
Department of Oral And Maxillofacial Surgery, Karpaga Vinayaga Institute of Dental Sciences, Gst Road, Palayanoor Post, Chinnakolambakkam Chengalpattu-603308
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
7904307597 |
| Fax |
|
| Email |
grkomfs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Acchuthakrishnan K A |
| Designation |
Post graduate student |
| Affiliation |
Karpaga Vinayaga Institute Of Dental Sciences |
| Address |
Department of Oral And Maxillofacial Surgery, Karpaga Vinayaga Institute of Dental Sciences, Gst Road, Palayanoor Post, Chinnakolambakkam Chengalpattu-603308
Department of Oral And Maxillofacial Surgery, Karpaga Vinayaga Institute of Dental Sciences, Gst Road, Palayanoor Post, Chinnakolambakkam Chengalpattu-603308
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
7904307597 |
| Fax |
|
| Email |
acchu7.ak@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral And Maxillofacial Surgery, Karpaga Vinayaga Institute of Dental Sciences, Gst Road, Palayanoor Post, Chinnakolambakkam Chengalpattu-603308 |
|
|
Primary Sponsor
|
| Name |
Acchuthakrishnan K A |
| Address |
Department of Oral And Maxillofacial Surgery, Karpaga Vinayaga Institute of Dental Sciences, Gst Road, Palayanoor Post, Chinnakolambakkam Chengalpattu-603308 |
| 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 Acchuthakrishnan |
Karpaga Vinayaga Institute of Dental Sciences |
Department of Oral And Maxillofacial Surgery, Karpaga Vinayaga Institute of Dental Sciences, Gst Road, Palayanoor Post, Chinnakolambakkam Chengalpattu-603308
Kancheepuram
TAMIL NADU |
7904307597
acchu7.ak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethical Commitee- Karpaga Vinayaga Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S026||Fracture of mandible, (2) ICD-10 Condition: S026||Fracture of mandible, (3) ICD-10 Condition: V229||Unspecified motorcycle rider injured in collision with two- or three-wheeled motor vehicle in traffic accident, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional arch bars |
To evaluate Erich’s arch bar in Maxillo-Mandibular fixation in terms of surgical time taken, glove perforation post operative occlusion, IMF stability, oral hygiene, screw assesment, mucosal ulcerations and non vitality characteristics at preoperative, Ist week, 6th week postoperatively Radiological assessment- loss of screw, screw breakage, screw covered by mucosa and iatrogenic damage to dental roots in IMF screws and EZY arch bars postoperatively. Functional assessment- post operative occlusion and IMF stability were recorded as satisfactory and non satisfactory based on Andrews Six Keys of Occlusion. Mucosal ulcerations caused by the hardware were assessed. Pre and post operative tooth vitality by the help of Electrical Pulp Tester. Needle stick injury or perforations assessed by water inflation method. Intraoperative assessment. Surgical time-Stopwatch. Oral hygiene assessment- OHI-S given by Greene and vermillion, for a period of six weeks. |
| Intervention |
Bone supported arch bars and Intermaxillary fixation screw. |
To evaluate Bone supported Ezy arch bars and IMF screw in Maxillo-Mandibular fixation in terms of surgical time taken, glove perforation post operative occlusion, IMF stability, oral hygiene, screw assesment, mucosal ulcerations and non vitality characteristics at preoperative, Ist week, 6th week postoperatively Radiological assessment- loss of screw, screw breakage, screw covered by mucosa and iatrogenic damage to dental roots in IMF screws and EZY arch bars postoperatively. Functional assessment- post operative occlusion and IMF stability were recorded as satisfactory and non satisfactory based on Andrews Six Keys of Occlusion. Mucosal ulcerations caused by the hardware were assessed. Pre and post operative tooth vitality by the help of Electrical Pulp Tester. Needle stick injury or perforations assessed by water inflation method. Intraoperative assessment-. Surgical time-Stopwatch. Oral hygiene assessment- OHI-S given by Greene and vermillion, for a period of six weeks. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who are consented to participate.
2.Patient’s in the age group of 16-60 years.
3. Patient’s with unilateral mandibular parasymphysis fracture
|
|
| ExclusionCriteria |
| Details |
1. Edentulous patients with underlying medical conditions
2. Pathologic and communited fracture of mandible
3. Patients with multiple fractures
4. Patient with fracture in other parts of body
5. Patients with primary and mixed dentition was excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Time required for the placement of device.
2.Pre operative occlusion ( Andrews six Keys of Occlusion)
3.Post operative occlusion ( Andrews six Keys of Occlusion)
|
1st week and 6th week.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Glove Perforation during Placement of the Device
2.Vitality of the teeth
3.Oral Hygiene Measure
4.Mucosal Ulcerations
5.Assesment of screws. |
1st week and 6th week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/07/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ø To evaluate Bone supported Ezy arch bars, IMF screws and Erich’s arch bar in Maxillo-Mandibular fixation in terms of surgical time taken, glove perforation post operative occlusion, IMF stability, oral hygiene, screw assesment, mucosal ulcerations and non vitality characteristics at preoperative, Ist week, 6th week postoperatively Radiological assessment- loss of screw, screw breakage, screw covered by mucosa and iatrogenic damage to dental roots in IMF screws and EZY arch bars postoperatively. Functional assessment- post operative occlusion and IMF stability were recorded as satisfactory and non satisfactory based on Angle’s classification. Mucosal ulcerations caused by the hardware were assessed. Pre and post operative tooth vitality by the help of Electrical Pulp Tester. Needle stick injury or perforations assessed by water inflation method. Intraoperative assessment-. Surgical time-Stopwatch. Oral hygiene assessment- OHI-S given by Greene and vermillion. |