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CTRI Number  CTRI/2024/12/078282 [Registered on: 18/12/2024] Trial Registered Prospectively
Last Modified On: 10/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing occlusion when two types of metal crowns are fabricated and cemented on molars  
Scientific Title of Study   Assessment of occlusal force distribution using T-SCAN pre-operative and post-cementation of full metal crowns fabricated by conventional and direct metal laser sintered (DMLS) technique -A split-mouth randomized clinical 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  Mayuri Suresh Rajavadha 
Designation  PG student 
Affiliation  KLE VK Institute of dental sciences 
Address  Department number 3, Prosthodontics and crown and bridge, Ground floor, KAHERS KLE Vishwanath Katti Institute of Dental Sciences, JNMC campus, Nehru nagar, Belagavi 590010, Karnataka, India
Nehru Nagar
Belgaum
KARNATAKA
590010
India 
Phone  09503096519  
Fax    
Email  rajavadha.mayuri@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Prashant Karni 
Designation  Reader 
Affiliation  KLE VK Institute of dental sciences 
Address  Department number 3, Prosthodontics and crown and bridge, Ground floor, KAHERS KLE Vishwanath Katti Institute of Dental Sciences, JNMC campus, Nehru nagar, Belagavi 590010, Karnataka, India
Nehru Nagar

KARNATAKA
590010
India 
Phone  9986497005  
Fax    
Email  prashantkarni@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr. Mayuri Suresh Rajavadha 
Designation  PG student 
Affiliation  KLE VK Institute of dental sciences 
Address  Department number 3, Prosthodontics and crown and bridge, Ground floor, KAHERS KLE Vishwanath Katti Institute of Dental Sciences, JNMC campus, Nehru nagar, Belagavi 590010, Karnataka, India
Nehru Nagar

KARNATAKA
590010
India 
Phone  09503096519  
Fax    
Email  rajavadha.mayuri@gmail.com  
 
Source of Monetary or Material Support  
Department of Prosthodontics and crown and bridge, KAHERs KLE Vishwanath Katti Institute of Dental Sciences, JNMC campus, Nehru nagar, Belagavi-590010, Karnataka, India 
 
Primary Sponsor  
Name  Dr. Mayuri Rajavadha 
Address  Department of Prosthodontics and crown and bridge, KAHERs KLE Vishwanath Katti Institute of Dental Sciences, JNMC campus, Nehru Nagar, Belagavi-590010, Karnataka, India 
Type of Sponsor  Other [(Self funded)] 
 
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 Mayuri Rajavadha  KAHERs KLE VK Institute of dental sciences  Department number 3, Ground floor, Prosthodontics and crown and bridge, KLE VK Institute of dental sciences, JNMC campus, Nehru nagar
Belgaum
KARNATAKA 
9503096519

rajavadha.mayuri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research and Ethics Committee KLE KVIDS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional metal crowns  Molar crowns fabricated by conventional lost salt technique for 3 months 
Intervention  DMLS metal crowns  Molar metal crowns fabricated by Direct Metal Laser Sintered technique for 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  54.00 Year(s)
Gender  Both 
Details  1) Patients who have undergone endodontic treatment in posterior teeth bilaterally, followed by post-obturation restoration in occlusion.
2) Teeth with one- or two-walled defects
3) Opposing teeth should have sound tooth structure without any restorations
 
 
ExclusionCriteria 
Details  1) Patients are not willing to participate in the study.
2) Patients treated with post and core.
3) Teeth having more than 2 walled defects
4) Patients having para-functional habits like bruxism and TMDs
5) Patients having missing teeth adjacent and opposite to endodontically treated teeth.
6) Patients having periapical pathologies after RCT.
7) Patients having periodontally compromised teeth
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1) To evaluate the occlusal force distribution by using T-scan pre-operative and post-cementation of full metal crowns fabricated by conventional technique.
2) To assess the occlusal force distribution by using T-scan pre-operative and post-cementation of crowns fabricated by DMLS technique.
3) To evaluate and compare the occlusal force distribution by using T-scan pre-operative and post-cementation of crowns fabricated by conventional and DMLS techniques. 
Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1) Patient comfort  Baseline 
 
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   Phase 2 
Date of First Enrollment (India)   11/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
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  

In patients who have undergone prosthetic rehabilitation with crowns and bridges, the distribution of occlusal forces may not be the same as before. Bite force evaluation helps to understand the mechanics of mastication, muscle activity during mastication, and the influence of physiological factors during the masticatory performance. These forces need to be evaluated and eliminated to achieve harmonious occlusal force distribution to protect the stomatognathic system. The prostheses fabricated by using conventional (lost wax technique) or DMLS technique are clinically acceptable. Comparative studies on the accuracy and precision of DMLS and conventionally fabricated crowns have been done. The studies have shown that a range of 0.4mm–2.8mm occlusal discrepancy is seen and is variable when posterior dental crowns are fabricated by conventional method or by DMLS method. The T-SCAN system records an accurate way of determining and evaluating the time sequence and force magnitude of occlusal contacts by converting qualitative data into quantitative parameters and displaying them digitally. Using this system, multiple corrections of occlusal discrepancies can be performed for every segment of the dentition. Comparative studies have been done to evaluate occlusal discrepancy by conventional methods, but the literature on T scans is sparse. Hence, the present study is undertaken to assess the occlusal force distribution by using T-scan pre-operative and post-cementation of metal crowns fabricated by conventional and DMLS techniques—a split-mouth randomized clinical study.

 
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