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CTRI Number  CTRI/2017/11/010544 [Registered on: 17/11/2017] Trial Registered Retrospectively
Last Modified On: 23/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Accuracy Impression materials-Vinyl Polyether Silicone & Addition Silicone using Monophase impression Technique 
Scientific Title of Study   A comparative evaluation of Accuracy between Vinyl Polyether Silicone and Addition Silicone using Monophase Impression Technique in Fixed Partial Denture 
Trial Acronym  Randomized Controlled Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSonia Abraham 
Designation  Student 
Affiliation  Indira Gandhi Institute Of Dental Sciences 
Address  Dept. of Prosthodontics and Crown& Bridge Sri Balaji Vidyapeeth Univ., MGMCRI Campus Pillayarkuppam Puducherry

Pondicherry
PONDICHERRY
Sonia Abraham
India 
Phone  9092064531  
Fax  9092064531  
Email  abrahamsonia10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sonia Abraham 
Designation  Student 
Affiliation  Indira Gandhi Institute Of Dental Sciences 
Address  Department of Prosthodontics and Crown & Bridge,SBV University, pillayarkuppam Puducherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9092064531  
Fax    
Email  abrahamsonia10@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manoharan PS 
Designation  Professor and Head 
Affiliation  Indira Gandhi Institute Of Dental Sciences 
Address  Department of Prosthodontics and Crown& Bridge, SBV university, Pillayarkuppam Puducherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9865019673  
Fax    
Email  manoharanps@igids.ac.in  
 
Source of Monetary or Material Support  
Dr.Sonia Abraham, Department of Prosthodontics and Crown & Bridge, Indira Gandhi Institute of Dental Sciences,Sri Balaji Vidyapeeth University,Pillayarkuppam, Puducherry607402 
 
Primary Sponsor  
Name  DrSonia Abraham 
Address  Department of Prosthodontics,Indira Gandhi Institute of Dental Sciences Pillayarkuppam Puducherry 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Sonia Abraham  Indira Gandhi Institute of Dental Sciences Pillayarkuppam 
 
Countries of Recruitment     United States of America
India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sonia Abraham  Indira Gandhi Institute of Dental Sciences  Pillayarkuppam, Puducherry
Pondicherry
PONDICHERRY 
9092064531

abrahamsonia10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional_Ethical _Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  , patient who need FPD which missing first molar or second premolar in upper or lower arch,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Addition Silicone  elastomeric impression material,Monophase Impression technique 
Intervention  Vinyl Polyether Silicone  Elastomeric Impression Material,Monophase impression technique 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Patient who needs Fixed Partial Denture in which missing tooth of first molar or second premolar in upper or lower arch 
 
ExclusionCriteria 
Details  xerostomia
limited mouth opening
pregnancy
alcohol/HIV
allergy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Linear dimensional accuracy,
Dimensional accuracy of dies 
Cast poured on 1st day and 7th day 
 
Secondary Outcome  
Outcome  TimePoints 
Tear,Voids  Magnification Loupes- 0 or 1 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   11/12/2015 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="10"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
on process  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

 Elastomeric impression is used for making final impression in fixed partial denture and for various different purposes in Prosthodontics. Addition Silicone is commonly used material which has various advantages and some limitations when evaluating accuracy especially when it is in contact with patients saliva, blood and room temperature. Recently Vinyl Poly Ether Silicone (VPES) have been stated to overcome the limitations as they are having different properties in evaluating accuracy in patients even after delayed pouring(after 7days). However, literature lacks in prospective randomised controlled trials in this topic to define the accuracy of both materials using monophase impression technique. Here in this study is to compare whether the impressions made from Vinyl polyether silicone (VPES) and Addition Silicone have maintained accuracy between 1st day and 7th day .

             In this parallel group randomised controlled trial 64 impressions were made in partially edentulous patients who were selected based on inclusion and exclusion criteria and were randomly assigned to two groups 1 and 2 through simple randomization. Impressions were made using group 1(VPES) and group 2(Addition Silicone) in same patient using monophase impression technique. After making final impressions, tear and voids (presence/ absence  of tear and voids) was evaluated using magnification loupes(3x).64 impressions were poured immediately as per manufacturer instructions and in same impressions cast were poured after 7 days of storage in humid lock safety pouches. 128 casts obtained on day 1 and day 7 from two groups were evaluated using Vernier Caliper (linear dimensional accuracy – AB,BC,CA that is two anteroposterior and one cross arch measurements) and also using stereomicroscope in dies of distal abutment (accuracy of dies –BL and MD that is buccolingual and mesiodistal measurements). Stereomicroscope measurements were evaluated using axio vision rel.48 software. These measurements were evaluated for both the groups by two different independent (blinded) observers who knew to operate the instrument. The observations obtained were tabulated and statistical analysis was done.

Primary objective

            To compare the linear dimensional accuracy of the impressions from first day to seventh day by measuring the casts obtained from the impressions in 3 planes: AB,BC,CA- anteroposteriorly two planes and cross arch using digital vernier caliper.

          To compare  the dimensional accuracy of dies of the impression from first day to seventh day by measuring the distal abutment in dies obtained from the impressions the buccolingual and mesiodistal dimensions of the dies using stereomicroscope and

Secondary objective

            To compare the tear and voids (or air bubbles) of the impressions made from Vinyl polyether silicone(VPES)  and Addition Silicone  using  magnification loupes(3X).

 
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