Evaluation of Impression Accuracy: Digital Scanner Versus Analog Technique

NCT ID: NCT07252869

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 51 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-15
• Study Completion Date: 2022-12-15

Brief Summary

The goal of this study is to evaluate the accuracy of intraoral impressions obtained using the Trios 3Shape® and Carestream CS 3600™ scanners, as well as traditional analog impressions using polyvinyl siloxane (PVS), in comparison to a gold standard represented by a laboratory scanner in 51 dental models from 42 patients affected by partial edentulism who required at least two implants.

Researchers compare Trios 3Shape®, Carestream CS 3600™ and polyvinyl siloxane (PVS) to see if there is a different accuracy.

Conditions

Accuracy and Precision of Noninvasive Measurement

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

TRIOS®-3Shape Group

Participants whose models were scanned using the TRIOS®-3Shape intraoral digital scanner. The deviation from the reference model was calculated to assess the accuracy of this technique.

Digital impression

Intervention Type: OTHER

impression taken by intraoral scanner

CS 3600® Carestream Group

Participants whose models were scanned using the CS 3600® Carestream Dental intraoral scanner. The deviation from the reference model was analyzed to evaluate the technique's precision.

Digital impression

Intervention Type: OTHER

impression taken by intraoral scanner

PVS Analog Impression Group

Participants whose impressions were taken using conventional polyvinylsiloxane (PVS) material. Cast models were scanned and compared to the reference to determine the accuracy of analog impressions.

impression

Intervention Type: OTHER

A Comparative Study of Digital Versus Analog Impressions

Interventions

impression

A Comparative Study of Digital Versus Analog Impressions

Intervention Type: OTHER

Digital impression

impression taken by intraoral scanner

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 80 years;
• Implant placement in healed bone sites (at least 8 weeks post-tooth extraction or at least 6 months after regenerative procedures), allowing guided implant insertion of at least 3.3 mm in diameter or 8.5 mm in length;
• Implant site without ongoing infections or dental extraction residues;
• Good systemic health conditions and adequate oral hygiene;
• Periapical and periodontal health of opposing teeth/implants in occlusion;
• Edentulism of at least two adjacent dental elements.

Exclusion Criteria

• Ongoing diseases requiring prolonged use of corticosteroids;
• Leukocyte dysfunction or deficiencies;
• Severe hemophilia;
• Current pregnancy;
• Past and/or current head/neck radiotherapy and/or chemotherapy;
• Renal insufficiency;
• Past and/or current use of bisphosphonates;
• Uncompensated endocrine disorders;
• Physical disabilities preventing adequate oral hygiene;
• Alcohol abuse and drug use;
• Smokers (>10 cigarettes/day);
• Untreated periodontitis;
• Mucosal diseases (e.g., erosive Lichen Planus);
• Severe parafunctional habits (e.g., bruxism or clenching);
• Persistent intraoral infections;
• Allergies or adverse reactions to restorative materials;
• Completely edentulous arches;
• Limited mouth opening;
• Inadequate oral hygiene or lack of motivation for self-care;
• Uncontrolled systemic diseases;
• Untreated or chronic oral cavity diseases;
• Fully edentulous arches.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Milan

OTHER

Sponsor Role: lead

Responsible Party

Stefano Storelli

Reasearcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinica Odontoiatrica Giorgio Vogel (Università degli studi di Milano)

Milan, Italy, Italy

Countries

Italy

Other Identifiers

1361

Identifier Type: -

Identifier Source: org_study_id