Digital vs Conventional Impressions Study

NCT ID: NCT03146780

Last Updated: 2021-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-16

Study Completion Date

2018-08-01

Brief Summary

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

Detailed Description

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Conditions

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Dental Prosthesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Conventional

Group Type PLACEBO_COMPARATOR

Conventional impression

Intervention Type 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 1

Group Type ACTIVE_COMPARATOR

Digital Scan 1

Intervention Type PROCEDURE

Direct intra-oral digital scans using Sirona Omnicam software.

Digital 2

Group Type ACTIVE_COMPARATOR

Digital Scan 2

Intervention Type PROCEDURE

Direct intra-oral digital scans using Planmeca Planscan software.

Digital 3

Group Type ACTIVE_COMPARATOR

Digital Scan 3

Intervention Type PROCEDURE

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

Interventions

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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").

Intervention Type PROCEDURE

Digital Scan 1

Direct intra-oral digital scans using Sirona Omnicam software.

Intervention Type PROCEDURE

Digital Scan 2

Direct intra-oral digital scans using Planmeca Planscan software.

Intervention Type PROCEDURE

Digital Scan 3

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Konstantinos Chochlidakis

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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RSRB#00065524

Identifier Type: -

Identifier Source: org_study_id

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