NCT05938400

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

July 2, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

March 25, 2023

Last Update Submit

December 11, 2023

Conditions

Endodontically Treated TeethMissing TeethDiscoloration, ToothProsthesis Failure, DentalOpen Margin on Tooth Restoration

Keywords

Polyvinylsiloxane impressionfixed prostheticsimpression techniquessingle stage impressiontwo step putty wash impressionmarginal fitprosthesis fitendodontically treated teeth

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    14 days

  • Incidence of prosthesis proximal contact inaccuracy as assessed by prosthesis contact assessment scale

    14 days

Study Arms (2)

One step polyvinylsiloxane impression technique

EXPERIMENTAL

All impressions in this group will be recorded in a single stage, mixing light-bodied PVS material and putty PVS material simultaneously and recording of impression of prepared tooth

Device: Polyvinylsiloxane impression with different techniques

Two step polyvinylsiloxane impression technique

ACTIVE COMPARATOR

All impressions in this group will be made in two stages, recording putty PVS impression first and then reloading it with light-bodied PVS material to record final impression.

Device: Polyvinylsiloxane impression with different techniques

Interventions

Polyvinylsiloxane impression with different techniquesDEVICE

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

One step polyvinylsiloxane impression techniqueTwo step polyvinylsiloxane impression technique

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Indication of fixed-fixed partial denture or crown
  • Good oral hygiene
  • Sound abutment tooth (vital/non-vital)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, 75600, Pakistan

Location

MeSH Terms

Conditions

Tooth, NonvitalAnodontiaTooth DiscolorationProsthesis Failure

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesTooth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer (Prosthodontics department), Principal investigator

Study Record Dates

First Submitted

March 25, 2023

First Posted

July 10, 2023

Study Start

July 2, 2023

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

December 12, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)