| 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
|
|
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). |