Impression & Prosthesis Quality Made From Different Polyvinylsiloxane Impression Techniques

Not Applicable

Completed

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

• Registration Number: NCT05938400
• Lead Sponsor: Dow University of Health Sciences

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.

Study Timeline

• Study First Submitted: 2023-03-25
• Study Start: 2023-07-02
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-10
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Indication of fixed-fixed partial denture or crown
• Good oral hygiene
• Sound abutment tooth (vital/non-vital)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Two step polyvinylsiloxane impression technique	Polyvinylsiloxane impression with different techniques	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.
One step polyvinylsiloxane impression technique	Polyvinylsiloxane impression with different techniques	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

Primary Outcome Measures

Name	Time	Method
Incidence of defects in impression recorded to fabricate dental prosthesis as assessed by impression quality assessment scale	10 minutes	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

Name	Time	Method
Incidence of prosthesis proximal contact inaccuracy as assessed by prosthesis contact assessment scale	14 days	Outcome assessment scale: 1. Acceptable, same as natural proximal contact on contralateral side; 2. Unacceptable; either tight or open proximal contact.
Incidence of prosthesis margin defects as assessed by Marginal adaptation assessment scale	14 days	Outcome assessment scale: 1. Adequate, adapted to tooth margins; 2. Inadequate, not accurately adapted to tooth margin

Trial Locations

Locations (1)

Dow University of Health Sciences; 🇵🇰 Karachi, Sindh, Pakistan