FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/063564 [Registered on: 04/03/2024] Trial Registered Prospectively
Last Modified On: 29/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluation of efficacy of twisted 120 degree plating system in mandibular angle fracture. 
Scientific Title of Study   Evaluation of efficacy of twisted 120 degree plating system in mandibular angle fracture: an in-vitro and in-vivo study. 
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 Supriyo Pal 
Designation  Assistant Professor 
Affiliation  Sri Siddhartha Academy of Higher Educatiom 
Address  Sri Siddhartha Dental College And Hospital. Department: Oral and MaxilloFacial Surgery Room no: 2
Sri Siddhartha Dental College And Hospital, B.H. Road, Agalakote, Tumkur
Tumkur
KARNATAKA
572107
India 
Phone  8101533613  
Fax    
Email  ssdcomfs@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Supriyo Pal 
Designation  Assistant Professor 
Affiliation  Sri Siddhartha Academy of Higher Educatiom 
Address  Sri Siddhartha Dental College And Hospital, Department: Oral and Maxillofacial Surgery Room No.: 2
Sri Siddhartha Dental College And Hospital, B.H. Road, Agalakote.
Tumkur
KARNATAKA
572107
India 
Phone  8101533613  
Fax    
Email  ssdcomfs@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Supriyo Pal 
Designation  Assistant Professor 
Affiliation  Sri Siddhartha Academy of Higher Educatiom 
Address  Sri Siddhartha Dental College And Hospital, Department: Oral and MaxilloFacial Surgery Room No. : 2
Sri Siddhartha Dental College And Hospital, B.H. Road, Agalakote.
Tumkur
KARNATAKA
572107
India 
Phone  8101533613  
Fax    
Email  ssdcomfs@gmail.com  
 
Source of Monetary or Material Support  
Sri Siddhartha Dental College and Hospital Department: Oral and MaxilloFacial Surgery Room No.:2 
 
Primary Sponsor  
Name  Dr Supriyo Pal 
Address  Sri Siddhartha Dental College And Hospital, B.H. Road, Agalakote, Tumkur TUMKUR-572107 KARNATAKA 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Supriyo Pal  Sri Siddhartha Dental College And Hospital  Department: Oral and MaxilloFcaial Surgery Room no.: 2 KARNATAKA
Tumkur
KARNATAKA 
8101533613

supriyopal11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Siddhartha Dental College and Hospital Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  L plate  It is a L shaped four hole with gap 2 mm stainless steel mini plate plate with 120 degree bend after 3 screws. Dimension of each hole is 2 mm and plate thickness is 1mm. Duration of intervention 3 years 
Comparator Agent  Straight Plate  It is a straight stainless steel mini plate with 4 hole with gap. Plate thickness is 1mm and hole dimension is 2mm. Duration of intervention 3 years 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients of age group 18 – 40 years having mandibular angle fracture and needs open reduction with internal fixation.
Patients who are willing and be able to provide informed consent and be available for multiple follow up visits. 
 
ExclusionCriteria 
Details  Acute or chronic localized infection at the angle of mandible.
Patients with any systemic illness.
Patients with an history of Hypersensitivity.
Pregnant patient.
Uncooperative patients.
Personal habits- tobacco chewing, smoking and chronic alcoholic patient.
Patients taking oral contraceptive pills. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Increase in occlusal stability.
Minimal lingual splaying. 
3 years 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in post operative complications like swelling, infection.
No extraoral scar. 
4-5 years no complications 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   19/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  19/03/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [supriyopal11@gmail.com].

  6. For how long will this data be available start date provided 22-01-2024 and end date provided 14-01-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Screws near the fracture site experiences greatest load. Using more screws and increasing the length of the plates helped to distribute the stress throughout the plates and screws which prevents complications like:

1. splaying at the lower border

2. lack of stability  against rotational forces

3. dehiscence of overlaying mucosa and

4. hardware failure.

So, we designed a noble twisted 1200 plating system and study of which will play an important role in improving the design and producing successful materials for medical and clinical purpose.

Thirty patients who fulfill the inclusion criteria and sign the consent form will be included in the study.  A detailed Case history and necessary information will be recorded

Methodology: 

Pre-op screening examination (1st visit)

Photographic records

Preoperative, intraoperative and postoperative photographs will be made.

Radiographic record

1. Preoperative panoramic view and mandibular occlusal view will be done to evaluate the site and type of fracture.

2. Immediate postoperative panoramic and occlusal view will be taken to evaluate the fracture reduction and placements of plates and lingual splay.

3. Follow up panoramic view and occlusal radiographs will be taken at 12th week of postoperative healing process.

Treatment

In all the patients Preoperative Erich’s arch bar will be placed. An intraoral mucosal incision will be made depending upon the anatomical location of fracture. Extraction of teeth in line of fracture, including impacted third molars, will be performed if indicated. The fracture fragments will be reduced in accurate anatomic pretraumatic occlusion state by open method and internal fixation will be done using 2.0mm twisted 120 degree stainless steel miniplate, and 2 mm × 8 mm screws. The intra oral incision sites will be closed with resorbable sutures.

All patients will be given intravenous antibiotics from the time of admission until discharge. On discharge, patients will be prescribed a 5, 7 day course of oral antibiotics All patients will be instructed to continue on soft diet for 4 weeks.

Patients will be observed for postoperative complication like Paresthesia, infection, masticatory difficulty, nonunion and malunion 

Postoperative evaluation: Assessment of occlusal stability and lingual splaying

a)   The occlusion achieved after fixation of mandibular fracture will be recorded and evaluated for change and stability during the first, second, fourth and 12th weeks following surgery.

Occlusal score proforma is given to operative surgeon who gives score accordingly:

        i.   1. Complete bilateral loss of occlusal contact of molars or cross bite or open bite: -1

      ii.    2. Unilateral loss of molar relationship: 0.

    iii.    3. No/minimal loss of molar relationship: +1.

Patient will be questioned about symptoms of possible complications and clinically evaluated postoperatively in the first, second, fourth and 12th weeks following surgery and details were recorded. The amount of mouth opening and patient’s ability to return to normal activities will be recorded.

The amount of reduction of lingual splay is evaluated by the operating surgeon using occlusal radiographs taken preoperatively and 3rd postoperative day.

The score for lingual splay evaluation is given as follows:

1. There is increase in lingual splay: -1.

2. Minimal/no change in lingual splay: 0.

3. Significant reduction in lingual splay: +1.

c)  Infinite Element analysis to determine: CBCT reports will be collected and the document will be transferred to COMSOL MultiPhysics Software along with pull forces of Masseter, Temporalis and medial Pterygoid muscle to determine:

1. Stability of the plate. 

2. Stress distribution along the plate and bone.

3. Ability to withstand the torsional and rotational forces

 
Close