Digital vs Conventional Impressions Study

Study Overview
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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.

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

Conditions
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Dental Prosthesis

Intervention / Treatment
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* Procedure: Conventional impression
* Procedure: Digital Scan 1
* Procedure: Digital Scan 2
* Procedure: Digital Scan 3


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Conventional<br> | Procedure: Conventional impression<br>* 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).<br>|
| Active Comparator: Digital 1<br> | Procedure: Digital Scan 1<br>* Direct intra-oral digital scans using Sirona Omnicam software.<br>|
| Active Comparator: Digital 2<br> | Procedure: Digital Scan 2<br>* Direct intra-oral digital scans using Planmeca Planscan software.<br>|
| Active Comparator: Digital 3<br> | Procedure: Digital Scan 3<br>* Direct intra-oral digital scans using 3M True Definition software.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |