Digital vs Conventional Impressions Study
Clinical Evaluation of Digital Versus Conventional Impressions Part I: Marginal and Internal Fit
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2017
CompletedFirst Posted
Study publicly available on registry
May 10, 2017
CompletedStudy Start
First participant enrolled
October 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedMarch 17, 2021
March 1, 2021
10 months
May 1, 2017
March 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (4)
Conventional
PLACEBO COMPARATORDigital 1
ACTIVE COMPARATORDigital 2
ACTIVE COMPARATORDigital 3
ACTIVE COMPARATORInterventions
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").
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rochester
Rochester, New York, 14620, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 1, 2017
First Posted
May 10, 2017
Study Start
October 16, 2017
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
March 17, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share