Evaluation of Impression Accuracy: Digital Scanner Versus Analog Technique

NCT07252869 | Completed

• 1 other identifier: 1361
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

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

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

Interventions

impression OTHER

A Comparative Study of Digital Versus Analog Impressions

PVS Analog Impression Group

Digital impression OTHER

impression taken by intraoral scanner

CS 3600® Carestream Group; TRIOS®-3Shape Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Clinica Odontoiatrica Giorgio Vogel (Università degli studi di Milano)

Milan, Italy, Italy

Location

MeSH Terms

Interventions

Inosine Monophosphate

Intervention Hierarchy (Ancestors)

Inosine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reasearcher

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: November 28, 2025
• Study Start: July 15, 2017
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: November 28, 2025

Record last verified: 2025-05

Locations

IT (1)