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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05938400
Other study ID # 2932
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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