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Digital vs Conventional Impressions Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03146780
Enrollment
22
Registered
2017-05-10
Start date
2017-10-16
Completion date
2018-08-01
Last updated
2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Prosthesis

Brief summary

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

Interventions

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).

PROCEDUREDigital Scan 1

Direct intra-oral digital scans using Sirona Omnicam software.

PROCEDUREDigital Scan 2

Direct intra-oral digital scans using Planmeca Planscan software.

PROCEDUREDigital Scan 3

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

Sponsors

University of Rochester
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with a correctly fitted prosthesisFrom 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026