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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05938400
Enrollment
62
Registered
2023-07-10
Start date
2023-07-02
Completion date
2023-09-30
Last updated
2023-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

DEVICEPolyvinylsiloxane impression with different techniques

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

Sponsors

Dow University of Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of defects in impression recorded to fabricate dental prosthesis as assessed by impression quality assessment scale10 minutesOutcome 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

MeasureTime frameDescription
Incidence of prosthesis margin defects as assessed by Marginal adaptation assessment scale14 daysOutcome 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 scale14 daysOutcome assessment scale: 1. Acceptable, same as natural proximal contact on contralateral side; 2. Unacceptable; either tight or open proximal contact.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026