Digital vs Conventional Impressions Study

March 15, 2021 updated by: Konstantinos Chochlidakis, University of Rochester

Clinical Evaluation of Digital Versus Conventional Impressions Part I: Marginal and Internal Fit

This study aims to compare how a single cap best fit on a tooth that is fabricated with digital and conventional impression techniques.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14620
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age of patient ≥ 18 years old
  • Good oral hygiene and compliance
  • In need of a single full-coverage crown on any vital premolar or first molar tooth
  • Opposing tooth is free of indirect restoration (crown)
  • Asymptomatic tooth free of pathology
  • No requirement for additional treatment (endodontic treatment, post and core, crown lengthening)
  • Anticipated supragingival or equigingival crown margin
  • Anticipated crown margin on natural tooth structure
  • Adequate abutment height after tooth preparation (minimum 4mm)

Exclusion Criteria:

  • Age of patient less than 18 years old
  • Poor oral hygiene and calculus on sample teeth
  • In need of a single full-coverage crown on tooth other than a vital premolar or first molar tooth
  • Opposing tooth is restored with indirect restoration
  • Periapical or periodontal pathology
  • Anticipated pulp exposure or need for additional treatment (endodontic treatment, post and core, crown lengthening)
  • Anticipated subgingival crown margin
  • Anticipated crown margin on direct restoration
  • Inadequate abutment height after tooth preparation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Conventional
Procedure: Conventional impression
A dental impression is a negative imprint of hard (teeth) and soft tissues in the mouth from which a positive reproduction (or cast) can be form using alginate material. They are made by using a container which is designed to roughly fit over the dental arches ("trays").
Active Comparator: Digital 1
Procedure: Digital Scan 1
Direct intra-oral digital scans using Sirona Omnicam software.
Active Comparator: Digital 2
Procedure: Digital Scan 2
Direct intra-oral digital scans using Planmeca Planscan software.
Active Comparator: Digital 3
Procedure: Digital Scan 3
Direct intra-oral digital scans using 3M True Definition software.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with a correctly fitted prosthesis
Time Frame: From impression stage to crown delivery, approximately four weeks. There are no follow up visits once crown is delivered.
Correct fit assessed by clinical assessment of internal and marginal crown fit.
From impression stage to crown delivery, approximately four weeks. There are no follow up visits once crown is delivered.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2017

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

May 1, 2017

First Submitted That Met QC Criteria

May 8, 2017

First Posted (Actual)

May 10, 2017

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • RSRB#00065524

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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