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Completed

NCT Number: NCT05938400

Impression & Prosthesis Quality Made From Different Polyvinylsiloxane Impression Techniques

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.

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Key information

Conditions

Endodontically Treated Teeth Anodontia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dental Pulp Diseases Discoloration, Tooth Missing Teeth Open Margin on Tooth Restoration Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Failure Prosthesis Failure, Dental Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Discoloration Tooth Diseases Tooth, Nonvital

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dow University of Health Sciences

Karachi, Sindh, 75600, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polyvinylsiloxane impression with different techniques

Device

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

Primary outcomes

  1. Incidence of defects in impression recorded to fabricate dental prosthesis as assessed by impression quality assessment scale

    Time frame: 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 outcomes

  1. Incidence of prosthesis margin defects as assessed by Marginal adaptation assessment scale

    Time frame: 14 days

    Outcome assessment scale: 1. Adequate, adapted to tooth margins; 2. Inadequate, not accurately adapted to tooth margin

  2. Incidence of prosthesis proximal contact inaccuracy as assessed by prosthesis contact assessment scale

    Time frame: 14 days

    Outcome assessment scale: 1. Acceptable, same as natural proximal contact on contralateral side; 2. Unacceptable; either tight or open proximal contact.

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 10, 2023
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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