Accuracy and Precision of Noninvasive MeasurementNCT07252869
Evaluation of Impression Accuracy: Digital Scanner Versus Analog Technique
An observational study of Accuracy and Precision of Noninvasive Measurement, run by University of Milan at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Accuracy and Precision of Noninvasive Measurement
- What is being tested?
- impression and Digital impression
- How many people
- 51 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jul 2017to 15 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Clinica Odontoiatrica Giorgio Vogel (Università degli studi di Milano)
Milan, Italy
About this study
Official title: 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.
- Being tested
- impression, Digital impression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
impressionOther
A Comparative Study of Digital Versus Analog Impressions
Digital impressionOther
impression taken by intraoral scanner
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: impression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Patients included in this prospective study were recruited from 2017 to 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start15 Jul 2017
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accuracy and Precision of Noninvasive MeasurementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Storelli, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252869
- Sponsor's protocol ID
- 1361
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy of Intraoral Scanner Versus Analog Impression in Implant Supported Rehabilitations Performed With Flapless Computer-Guided Implantology
- ClinicalTrials.gov ID
- NCT07252869
- Acronym / sponsor ID
- 1361
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 15 Jul 2017 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TRIOS®-3Shape Group | – | Other: Digital impressionParticipants 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. |
| CS 3600® Carestream Group | – | Other: Digital impressionParticipants 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. |
| PVS Analog Impression Group | – | Other: impressionParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| impressionA Comparative Study of Digital Versus Analog Impressions | Other | PVS Analog Impression Group |
| Digital impressionimpression taken by intraoral scanner | Other | CS 3600® Carestream Group, TRIOS®-3Shape Group |
Primary outcome
Clinical and radiological evaluation of soft tissues and bone level in implant supported rehabilitations performed with Flapless Computer-Guided implantology. A prospective clinical study.
Time frame: Patients included in this prospective study were recruited from 2017 to 2022
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Accuracy and Precision of Noninvasive Measurement, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and radiological evaluation of soft tissues and bone level in implant supported rehabilitations performed with Flapless Computer-Guided implantology. A prospective clinical study. (time frame: Patients included in this prospective study were recruited from 2017 to 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.