Digital vs Conventional Impressions Study

Dental Prosthesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03146780
• Other study ID #: RSRB#00065524
• Status: Completed
• Phase: N/A
• Start date: October 16, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: March 2021
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Prosthesis

Intervention

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").
• Digital Scan 1
Direct intra-oral digital scans using Sirona Omnicam software.
• Digital Scan 2
Direct intra-oral digital scans using Planmeca Planscan software.
• Digital Scan 3
Direct intra-oral digital scans using 3M True Definition software.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with a correctly fitted prosthesis	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.