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CTRI Number  CTRI/2022/05/042694 [Registered on: 20/05/2022] Trial Registered Prospectively
Last Modified On: 29/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   A study using different bite registration materials to check its accuracy and reproducibility. 
Scientific Title of Study   An In-vivo Study To Analyse The Clinical Accuracy And Reproducibility Of Interocclusal Records Made By Aluwax Bite Registration Material, Vinyl Polysiloxane Bite Registration Material And Intraoral Scanning Device.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Charmi B Panchal 
Designation  PG Student 
Affiliation  Vishwajyoti Ashram Near, Muj Mahuda, Vadodara, Gujarat 390011 
Address  Department of Prosthodontics, Manubhai Patel Dental College and Research Centre, Ground floor, Vadodara

Vadodara
GUJARAT
390011
India 
Phone    
Fax    
Email  drcharmipanchal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrSonal Mehta 
Designation  Professor and PG Guide 
Affiliation  Vishwajyoti Ashram Near, Muj Mahuda, Vadodara, Gujarat 390011 
Address  Department of Prosthodontics, Manubhai Patel Dental College and Research Centre, Ground floor, Vadodara

Vadodara
GUJARAT
390011
India 
Phone  9428974820  
Fax    
Email  docsonalmehta@gmail.com  
 
Details of Contact Person
Public Query  
Name  Charmi B Panchal 
Designation  PG Student 
Affiliation  Vishwajyoti Ashram Near, Muj Mahuda, Vadodara, Gujarat 390011 
Address  Department of Prosthodontics, Manubhai Patel Dental College and Research Centre, Ground floor, Vadodara

Vadodara
GUJARAT
390011
India 
Phone    
Fax    
Email  drcharmipanchal@gmail.com  
 
Source of Monetary or Material Support  
Department of Prosthodontics, Manubhai Patel Dental College and Research Centre, Vishwajyoti Ashram Near Vidyakunj School, Muj Mahuda, Vadodara, Gujarat 390011 
 
Primary Sponsor  
Name  Charmi B Panchal 
Address  Department of Prosthodontics, Manubhai Patel Dental College and Resaerch Centre, Grounf floor,Vadodara 
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 
Charmi B Panchal  Manubhai Patel Dental College  Department of Prosthodontics, Manubhai Patel Dental College and Research Centre, Ground floor, Vadodara
Vadodara
GUJARAT 		 7043504545

drcharmipanchal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Intitutional ethics committee (IEC) for Research  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 
Intervention  Inter occlusal bite registration materials , vinyl polysiloxane bite registration material   vinyl polysiloxane bite registration material as an intervention material for the study and the duration of study is 12 month 
Comparator Agent  Inter occlusal bite registration materials,Intra-oral, Extra-oral scanning device  Aluwax interocclusal records,Virtual interocclusal records..the duration of study is for 12 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Gender: Male or Female,
Age: 18 years to 40 years old,
Angle’s class-1 occlusion,
Fully dentate maxillary and
mandibular arches. [At least 28 teeth
present] 
 
ExclusionCriteria 
Details  Restored teeth,
Developmental anomalies of enamel, dentin and pulp,
Pathological attrition,
Worn-out dentition,
TMJ disorders.
o Neuromuscular disorders.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1)To evaluate the clinical accuracy and reproducibility of aluwax interocclusal records
2)To evaluate clinical accuracy and reproducibility of vinyl polysiloxane interocclusal records
3)To evaluate clinical accuracy and reproducibility of virtual interocclusal records 		 Single Base line time 
 
Secondary Outcome  
Outcome  TimePoints 
1) To evaluate the clinical accuracy and
reproducibility of aluwax interocclusal records and virtual interocclusal records
2)To evaluate the clinical accuracy and
reproducibility of vinyl polysiloxane interocclusal records and virtual interocclusal records
3)To evaluate the clinical accuracy and
reproducibility of aluwax interocclusal records and vinyl polysiloxane interocclusal records 		 Single base line time 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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)   06/06/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  06/06/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   In this study will evaluate the clinical accuracy and reproducibility of the various interocclusal bite registration material like aluwax interocclusal record material, vinyl polysiloxan interocclusal record material and virtual interocclusal records. This study will help to choose the best interocclusal record material by its accuracy and reproducibility for various prosthetic rehabilitation procedure. In this study will choose 12 participants by inclusion and exclusion criteria of the study and will inform about the study to patient by consent form. With the help of the intraoral scanning device will do baccal scan three times from left molar to right molar region  and save these 3 scans individually as a STL file. Will take aluwax interocclusal records and vinyl polysiloxane interocclusal record 3 times in same participant by same process and will also make upper and lower individual impression with vinyl polysiloxan putty impression material and these interocclusal record made by aluwax and vinyl polysiloxane materials and individual impression of upper and lower jaw will be scanned by the extraoral scanning device .After scanning, digital articulation will be done save these data as STL file. Now all the data saved as STL file will send to the comparartor software to analyse the clinical accuracy and reproducibility of the interocclusal bite registration material. 
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