Clinical trial NCT05938400: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of defects in impression recorded to fabricate dental prosthesis as assessed by impression quality assessment scale
timeFrame: 10 minutes
Secondary outcomes:
measure: Incidence of prosthesis margin defects as assessed by Marginal adaptation assessment scale
timeFrame: 14 days
measure: Incidence of prosthesis proximal contact inaccuracy as assessed by prosthesis contact assessment scale
timeFrame: 14 days
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow University of Health Sciences
state: Sindh
Study officials:
References: