Impression & Prosthesis Quality Made From Different Polyvinylsiloxane Impression Techniques

Endodontically Treated Teeth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05938400
• Other study ID #: 2932
• Status: Completed
• Phase: N/A
• Start date: July 2, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: December 2023
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anodontia
• Discoloration, Tooth
• Endodontically Treated Teeth
• Missing Teeth
• Prosthesis Failure
• Tooth Discoloration
• Tooth Loss
• Tooth, Nonvital

Intervention

Device:
• Polyvinylsiloxane impression with different techniques
One step impression technique will be compared with the standard two step technique

Locations

Country	Name	City	State
Pakistan	Dow University of Health Sciences	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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