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Impression & Prosthesis Quality Made From Different Polyvinylsiloxane Impression Techniques

Primary Purpose

Endodontically Treated Teeth, Missing Teeth, Discoloration, Tooth

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Polyvinylsiloxane impression with different techniques
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontically Treated Teeth focused on measuring Polyvinylsiloxane impression, fixed prosthetics, impression techniques, single stage impression, two step putty wash impression, marginal fit, prosthesis fit, endodontically treated teeth

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Indication of fixed-fixed partial denture or crown Good oral hygiene Sound abutment tooth (vital/non-vital) Exclusion Criteria: Failure to provide written consent to participation in study Long span bridges (Greater than 3 units) Patients with bleeding disorders Cases indicated for resin-bonded prosthesis

Sites / Locations

  • Dow University of Health SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

One step polyvinylsiloxane impression technique

Two step polyvinylsiloxane impression technique

Arm Description

All impressions in this group will be recorded in a single stage, mixing light-bodied PVS material and putty PVS material simultaneously and recording of impression of prepared tooth

All impressions in this group will be made in two stages, recording putty PVS impression first and then reloading it with light-bodied PVS material to record final impression.

Outcomes

Primary Outcome Measures

Incidence of defects in impression recorded to fabricate dental prosthesis as assessed by impression quality assessment scale
Outcome assessment scale: 1. Perfect impression, no voids or defects; 2. Acceptable impression, minimal defects in non critical region; 3. Unacceptable impression, defects involving critical region.

Secondary Outcome Measures

Incidence of prosthesis margin defects as assessed by Marginal adaptation assessment scale
Outcome assessment scale: 1. Adequate, adapted to tooth margins; 2. Inadequate, not accurately adapted to tooth margin
Incidence of prosthesis proximal contact inaccuracy as assessed by prosthesis contact assessment scale
Outcome assessment scale: 1. Acceptable, same as natural proximal contact on contralateral side; 2. Unacceptable; either tight or open proximal contact.

Full Information

First Posted
March 25, 2023
Last Updated
July 3, 2023
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05938400
Brief Title
Impression & Prosthesis Quality Made From Different Polyvinylsiloxane Impression Techniques
Official Title
Clinical Evaluation of Impressions Made Using One Step & Two Step Polyvinylsiloxane Impression Techniques and Resulting Fixed Prosthesis-A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This randomized controlled trial is to clinically assess and compare impression quality of polyvinylsiloxane impression material using one step (experimental) and two step (control) impression techniques and its effect on marginal fit of prosthesis and proximal contact of prosthesis.
Detailed Description
Study participants will be randomly allocated to either of the two groups (experimental or control) through software-generated random numbers. Indicated tooth will be prepared to receive a fixed prosthesis under local anesthesia as per standard guidelines. Polyvinylsiloxane (PVS) impressions will be recorded in stock tray after moisture control, according to the assigned group. In experimental group, light body and putty PVS will be mixed simultaneously and placed in stock tray to record impressions in single stage. In control group, a putty PVS impression will be recorded first in stock tray and allowed to set. After setting of putty PVS, light-bodied PVS material will be applied to recorded impression surface and reseated in mouth to record final impression in second stage. All impressions will be disinfected according to the recommended guidelines. All impressions will then be assessed by a senior clinician using 3.5 x magnification loupe and graded according to the selected criteria. Impressions will then be poured in dental stone and prosthesis will be manufactured in dental lab. Participants will be recalled for prosthesis trial and fit assessment of prosthesis margins using a dental explorer instrument and visual evaluation. Proximal contact of prosthesis will be graded according the criteria and assessed using dental floss. Satisfactory prostheses will be cemented after final adjustments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontically Treated Teeth, Missing Teeth, Discoloration, Tooth, Prosthesis Failure, Dental, Open Margin on Tooth Restoration
Keywords
Polyvinylsiloxane impression, fixed prosthetics, impression techniques, single stage impression, two step putty wash impression, marginal fit, prosthesis fit, endodontically treated teeth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
One step polyvinylsiloxane impression technique
Arm Type
Experimental
Arm Description
All impressions in this group will be recorded in a single stage, mixing light-bodied PVS material and putty PVS material simultaneously and recording of impression of prepared tooth
Arm Title
Two step polyvinylsiloxane impression technique
Arm Type
Active Comparator
Arm Description
All impressions in this group will be made in two stages, recording putty PVS impression first and then reloading it with light-bodied PVS material to record final impression.
Intervention Type
Device
Intervention Name(s)
Polyvinylsiloxane impression with different techniques
Intervention Description
One step impression technique will be compared with the standard two step technique
Primary Outcome Measure Information:
Title
Incidence of defects in impression recorded to fabricate dental prosthesis as assessed by impression quality assessment scale
Description
Outcome assessment scale: 1. Perfect impression, no voids or defects; 2. Acceptable impression, minimal defects in non critical region; 3. Unacceptable impression, defects involving critical region.
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Incidence of prosthesis margin defects as assessed by Marginal adaptation assessment scale
Description
Outcome assessment scale: 1. Adequate, adapted to tooth margins; 2. Inadequate, not accurately adapted to tooth margin
Time Frame
14 days
Title
Incidence of prosthesis proximal contact inaccuracy as assessed by prosthesis contact assessment scale
Description
Outcome assessment scale: 1. Acceptable, same as natural proximal contact on contralateral side; 2. Unacceptable; either tight or open proximal contact.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Indication of fixed-fixed partial denture or crown Good oral hygiene Sound abutment tooth (vital/non-vital) Exclusion Criteria: Failure to provide written consent to participation in study Long span bridges (Greater than 3 units) Patients with bleeding disorders Cases indicated for resin-bonded prosthesis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Humera Nasim, M.Sc.
Phone
922199215754
Email
hnasim690@gmail.com
Facility Information:
Facility Name
Dow University of Health Sciences
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75600
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Humera Nasim, M.Sc.
Phone
922199215754
Email
hnasim690@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Impression & Prosthesis Quality Made From Different Polyvinylsiloxane Impression Techniques

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