Impression & Prosthesis Quality Made From Different Polyvinylsiloxane Impression Techniques

Clinical Evaluation of Impressions Made Using One Step & Two Step Polyvinylsiloxane Impression Techniques and Resulting Fixed Prosthesis-A Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Endodontically Treated Teeth; Discoloration, Tooth; Missing Teeth; Prosthesis Failure, Dental; Open Margin on Tooth Restoration
• Intervention / Treatment: Device: Polyvinylsiloxane impression with different techniques

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75600
      • Dow University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Polyvinylsiloxane impression with different techniques; One step impression technique will be compared with the standard two step technique
Active Comparator: 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.	Device: Polyvinylsiloxane impression with different techniques; One step impression technique will be compared with the standard two step technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	14 days
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.	14 days

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2023
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: March 25, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: impression techniques; endodontically treated teeth; Polyvinylsiloxane impression; fixed prosthetics; single stage impression; two step putty wash impression; marginal fit; prosthesis fit
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Congenital Abnormalities; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Dental Pulp Diseases; Tooth Abnormalities; Tooth Loss; Tooth, Nonvital; Tooth Discoloration; Prosthesis Failure; Anodontia
• Other Study ID Numbers: 2932

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No