NCT03146780CompletedNot Applicable
Clinical Evaluation of Digital Versus Conventional Impressions Part I: Marginal and Internal Fit
University of Rochester1 site in 1 country22 target enrollmentStarted: October 16, 2017Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Rochester
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Number of participants with a correctly fitted prosthesis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Conventional
Placebo Comparator
Intervention: Conventional impression (Procedure)
Digital 1
Active Comparator
Intervention: Digital Scan 1 (Procedure)
Digital 2
Active Comparator
Intervention: Digital Scan 2 (Procedure)
Digital 3
Active Comparator
Intervention: Digital Scan 3 (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Konstantinos Chochlidakis
Associate Professor
University of Rochester
Study Sites (1)
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