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CTRI Number  CTRI/2023/07/055795 [Registered on: 28/07/2023] Trial Registered Prospectively
Last Modified On: 31/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A Study To Compare Digital Accuracy Of Bite Registration Materials: Polyvinyl Siloxane Versus Thermoplastic Resin. 
Scientific Title of Study   Evaluation And Comparison Of The Accuracy Of Polyvinyl Siloxane And Thermoplastic Resin Interocclusal Registration Materials Using Digital Methods: An 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 Sharwari Bhatkar 
Designation  Post Graduate Student 
Affiliation  Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. 
Address  104, First Floor, Department of Prosthodontics, Crown And Bridge, Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. Maharashtra, India

Nagpur
MAHARASHTRA
441110
India 
Phone  9970616885  
Fax    
Email  sharwaribhatkar0304@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Krishankumar Lahoti 
Designation  Reader And PG Guide 
Affiliation  Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. 
Address  104, First Floor, Department of Prosthodontics, Crown And Bridge, Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. Maharashtra, India

Nagpur
MAHARASHTRA
441110
India 
Phone  9763711501  
Fax    
Email  kk.lahoti@sdk-dentalcollege.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Krishankumar Lahoti 
Designation  Reader And PG Guide 
Affiliation  Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. 
Address  104, First Floor, Department of Prosthodontics, Crown And Bridge, Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. Maharashtra, India

Nagpur
MAHARASHTRA
441110
India 
Phone  9763711501  
Fax    
Email  kk.lahoti@sdk-dentalcollege.edu.in  
 
Source of Monetary or Material Support  
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital , Hingna, Nagpur. 
 
Primary Sponsor  
Name  Dr Sharwari Bhatkar 
Address  Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital , Hingna, Nagpur, Maharashtra 
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 
Sharwari Bhatkar  Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital  104, Department Of Prosthodontics, Crown And Bridge, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Hingna, Nagpur, Maharashtra
Nagpur
MAHARASHTRA 		 9970616885

sharwaribhatkar0304@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commitee- Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intraoral Scanner  A complete intraoral scanning will be done with the help of an intraoral scanner to get the most accurate form of tooth preparation done. 
Intervention  Polyvinyl Siloxane  Polyvinyl Siloxane is the most widely used material for bite registration. 
Intervention  Thermoplastic Resin  The newly introduced material for bite registration. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Patients requiring fixed prosthesis with respect to endodontically treated first or second
molar with no distal teeth present.
Volunteer patients who agree to give informed consent will be considered as individuals for the research. 
 
ExclusionCriteria 
Details  Patients having a neuromuscular disorder.Patients having a history or suffering from gingival and periodontal diseases.
Patients with poor oral hygiene. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate the accuracy of Polyvinyl Siloxane as an interocclusal registration material obtained from an extraoral digital scanner.
2. To evaluate the accuracy of Thermoplastic Resin as an interocclusal registration material obtained from an extraoral digital scanner.
 		 After the patients first visit Tooth preparation will be done.
Firstly Polyvinyl Siloxane will be added on all surfaces of the prepared tooth & a bite will be obtained.
Secondly, Thermoplastic Resin will be added on all surfaces of the prepared tooth and a bite will be obtained.
The thickness and accuracy of the materials will be assessed after a day. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the accuracy of Polyvinyl Siloxane & Thermoplastic Resin as an interocclusal registration material obtained from an extraoral digital scanner with the intraoral scanner.  After obtaining bites from both the bite registration materials, it will be compared extraorally with the extraoral scanner.
The bites obtained will then be compared with an intraoral scanner within a week. 
 
Target Sample Size   Total Sample Size="14"
Sample Size from India="14" 
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
Modification(s)  		 N/A 
Date of First Enrollment (India)   14/08/2023 
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="1"
Months="3"
Days="2" 
Recruitment Status of Trial (Global)
Modification(s)  		 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   Dentistry has witnessed significant advancements due to new technologies, particularly digital scanners and improved materials. These innovations have revolutionized dental practices, providing better options for oral health through enhanced durability and aesthetics.According to the Glossary of Prosthodontics Terms 9th Edition-“An interocclusal record is defined as a registration of the positional relationship of the opposing teeth or arches; a record of the positional relationship of the teeth or jaws to each other.”Interocclusal registration materials have the main purpose of accurately replicating cuspal morphology, withstanding compressive forces, and maintaining dimensional stability during transport. These materials are used to record the occlusal relationship between natural and artificial teeth, particularly for prosthesis planning. They should offer minimal resistance before setting, be rigid or resilient post-setting with minimal dimensional changes, and be easy to manipulate without adverse effects on tissues. It’s crucial for the material to accurately record the incisal and occlusal surfaces of teeth and be verifiable for precise bite registration. Examples of interocclusal materials include Addition silicone impression material, Zinc oxide eugenol paste, Corrected wax, Metalized wax, Elastomers, Impression plaster, Acrylic resin, and Pressure-sensitive films. The selection of the right interocclusal recording material is crucial for reliable prosthodontic treatment. New materials have led to significant advancements in achieving accurate results. Intraoral scanners have improved precision compared to conventional methods. Polyvinyl siloxane is considered the optimal material, and its accuracy will be compared to thermoplastic resin using intraoral scanners.PRIMARY OBJECTIVES 1)To evaluate the accuracy of Polyvinyl Siloxane as an interocclusal registration material obtained from an extraoral digital scanner. 2)To evaluate the accuracy of Thermoplastic Resin as an interocclusal registration material obtained from an extraoral digital scanner. 3)To compare the accuracy of Polyvinyl Siloxane and Thermoplastic Resin as an interocclusal registration material obtained from an extraoral digital scanner with the intraoral scanner. Method of measurement:In the study, 14 candidates will be carefully selected based on specific criteria. Tooth preparation for crown prosthesis will be carried out on endodontically treated teeth without distal teeth present. Intraoral scanning will be performed following the manufacturer’s instructions, including air-drying the teeth before scanning. Both upper and lower arches, along with their occlusal surfaces and interocclusal relationship, will be thoroughly scanned. The subjects will be instructed to position their mandible in the maximal intercuspal position, and the facial surfaces of the maxillary and mandibular arches will be scanned without any pauses. The captured images will be exported in STL format. Additionally, two sets of impressions will be taken using Addition silicone impression material, and intermaxillary relationships will be recorded with either Polyvinyl Siloxane or Thermoplastic Resin materials. 
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