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OpenTrials
Completed

NCT Number: NCT03146780

Digital vs Conventional Impressions Study

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

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Key information

Conditions

Dental Prosthesis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14620, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

conventional impression

Procedure

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").

Digital Scan 1

Procedure

Direct intra-oral digital scans using Sirona Omnicam software.

Digital Scan 2

Procedure

Direct intra-oral digital scans using Planmeca Planscan software.

Digital Scan 3

Procedure

Direct intra-oral digital scans using 3M True Definition software.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 10, 2017
Registry last updated
Mar 17, 2021

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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