Evaluation of Impression Accuracy: Digital Scanner Versus Analog Technique

Evaluation of the Accuracy of Intraoral Scanner Versus Analog Impression in Implant Supported Rehabilitations Performed With Flapless Computer-Guided Implantology

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.

Study Overview

• Status: Completed
• Conditions: Accuracy and Precision of Noninvasive Measurement
• Intervention / Treatment: Other: Digital impression; Other: impression

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• Italy
  • Italy
    • Milan, Italy, Italy
      • Clinica Odontoiatrica Giorgio Vogel (Università degli studi di Milano)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of patients seeking implant treatment at the Implantology and Prosthodontics Department of the Giorgio Vogel Odontostomatological Clinic, ASST Santi Paolo e Carlo, Milan.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Digital impression; 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.	Other: Digital impression; 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.	Other: impression; A Comparative Study of Digital Versus Analog Impressions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical and radiological evaluation of soft tissues and bone level in implant supported rehabilitations performed with Flapless Computer-Guided implantology. A prospective clinical study.	The statistical analyses were performed using AnalystSoft StatPlus®. Using GOM Inspect by Zeiss®, the mean deviation values from the reference file were calculated for each model. They were expressed in absolute terms. In our study, for each of the three test techniques (TRIOS®-3Shape, CS 3600® Carestream Dental, and PVS), the average of the values obtained from the superimpositions of 51 models was calculated, resulting in the mean deviation of each method from the reference. For data analysis, a one-way ANOVA test and a two-sample Z-test were applied, with a significance level (α) set at 0.05. These tests were used both to compare the mean distances and to assess the standard deviations of the deviations. Each technique was considered accurate if its mean deviation was less than 30 μm.	Patients included in this prospective study were recruited from 2017 to 2022

Collaborators and Investigators

• Sponsor: University of Milan

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2017
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: May 21, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleic Acids, Nucleotides, and Nucleosides; Purines; Ribonucleotides; Nucleotides; Purine Nucleotides; Inosine Nucleotides; Inosine Monophosphate
• Other Study ID Numbers: 1361

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No