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CTRI Number  CTRI/2024/01/061556 [Registered on: 18/01/2024] Trial Registered Prospectively
Last Modified On: 16/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   cross sectional study 
Study Design  Other 
Public Title of Study   OCCLUSAL EVALUATION OF TOOTH/TEETH SUPPORTED RESTORATIONS –A POST RESTORATION QUANTITATIVE ANALYSIS 
Scientific Title of Study   OCCLUSAL EVALUATION OF TOOTH/TEETH SUPPORTED RESTORATIONS –A POST RESTORATION QUANTITATIVE ANALYSIS 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashika 
Designation  Postgraduate student 
Affiliation  Sri Siddhartha dental college and hospital 
Address  Department of Prosthodontics and Crown & Bridge Room number 4 Sri Siddhartha dental college & hospital agalakote B H Road tumkur 07

Tumkur
KARNATAKA
572107
India 
Phone  8105092461  
Fax    
Email  ashika.maruthi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Ramesh chaudhary 
Designation  Proffesor 
Affiliation  Sri Siddhartha dental college and hospital 
Address  Department of Prosthodontics and Crown & Bridge Room number 4 Sri Siddhartha Dental College & Hospital agalakote

Tumkur
KARNATAKA
572107
India 
Phone  9845206898  
Fax    
Email  drramco@gmail.com  
 
Details of Contact Person
Public Query
 
Name  ashika 
Designation  postgraduate student 
Affiliation  sri siddhartha dental college and hospital 
Address  department of prosthodontics and crown & bridge Room number 4 sri siddhartha dental college & hospital agalakote

Tumkur
KARNATAKA
572103
India 
Phone  8105092461  
Fax    
Email  ashika.maruthi@gmail.com  
 
Source of Monetary or Material Support  
Sri Siddhartha dental college and hospital  
 
Primary Sponsor  
Name  AshikaM 
Address  sri siddhartha dental college and hospital agalkote b h road tumkur  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Pooja pandurangi  Sri Siddhartha Dental College and Hospital Agalkote B H Road tumkur  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrAshika  Sri Siddhartha Dental College and Hospital   Department of Prosthodontics and Crown & Bridge Room number 4 Sri Siddhartha Dental College & Hospital Agalakote
Tumkur
KARNATAKA 
8105092461

ashika.maruthi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Clearance Certificate  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Age from 18-60 years males and females people having posterior crown/bridges apposing natural teeth and restored within 1 year no relatively obvious tmj abnormalities  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients who are restored within one year
The patient having bridge in the posterior region
Patient having no relatively obvious TMJ abnormalities
Prosthesis opposing should be natural teeth
All Full crown restorations considered
Patients belonging to both genders considered
 
 
ExclusionCriteria 
Details  Patients having prostheses opposing the restoration
Patients having long-span bridges in the posterior region.
Patients having TMJ-related problems
Patients restored more than a year of restoration
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the occlusal discrepancy using t scan system in the patients   4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
to assess the relation between patient perception & t scan report on occlusal discrepancies  4 weeks 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   24/01/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  24/01/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
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  

Controlling occlusal forces is the main focus of occlusal adjustments and restorative dentistry, aiming to ensure their effective management. Despite the dentist’s unwavering commitment to this objective, challenges related to imbalances in occlusal forces continue to persist.

Achieving optimal force distribution can significantly reduce the stress exerted on teeth, dental implants, and restorative materials. To visualize the occlusal contacts, different inks, and films are employed, aiding in making informed decisions regarding adjustment therapy. However, these decisions often rely on the subjective interpretation of the operator regarding the force experienced at each contact point.

By utilizing a computerized occlusal analysis system (T-Scan II, Tekscan Inc. S. Boston, MA, USA), operators can employ a measurement-based approach to obtain objective data on occlusal contact relative force in real time. This advanced system has been proven to enhance the process of achieving refined occlusal force equalization. The entire system affords the operator qualitative and quantitative occlusal data, from which occlusal adjustment therapy decisions can be measurably discerned.

Thus this short study evaluates the occlusal discrepancies in patients with 3 unit metal-ceramic restorations using T scan

 
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