Impression & Prosthesis Quality Made From Different Polyvinylsiloxane Impression Techniques

NCT ID: NCT05938400

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-02

Study Completion Date

2023-09-30

Brief Summary

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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

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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.

Conditions

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Endodontically Treated Teeth Missing Teeth Discoloration, Tooth Prosthesis Failure, Dental Open Margin on Tooth Restoration

Keywords

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Polyvinylsiloxane impression fixed prosthetics impression techniques single stage impression two step putty wash impression marginal fit prosthesis fit endodontically treated teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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One step polyvinylsiloxane impression technique

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

Group Type EXPERIMENTAL

Polyvinylsiloxane impression with different techniques

Intervention Type DEVICE

One step impression technique will be compared with the standard two step technique

Two step polyvinylsiloxane impression technique

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.

Group Type ACTIVE_COMPARATOR

Polyvinylsiloxane impression with different techniques

Intervention Type DEVICE

One step impression technique will be compared with the standard two step technique

Interventions

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Polyvinylsiloxane impression with different techniques

One step impression technique will be compared with the standard two step technique

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dow University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Humera Nasim

Lecturer (Prosthodontics department), Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dow University of Health Sciences

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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2932

Identifier Type: -

Identifier Source: org_study_id