Full-arch ImpressionNCT06658366
The Accuracy of Intraoral Scanning Systems for Full-Arch Impressions Is Examined in 10 Participants
A study testing impression of the teeth in people with Full-arch Impression, run by University of Zurich at 1 site in Switzerland.
Trial summary
For several decades now, modern procedures have allowed dentists to capture your teeth using digital cameras. This digital procedure is increasingly replacing traditional impressions with a viscous mass that hardens in the mouth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Full-arch Impression
- What is being tested?
- impression of the teeth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Oct 2024to 30 Apr 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All genders, minimum age for participation is 18 years
- Good general health and healthy dental conditions (gaps with a maximum of 1 missing tooth are permitted)
- Written consent after informed consent discussion is available
Who cannot join
- participants under the age of 18
- Addicts or participants with impaired cognitive abilities that do not allow the participant to assess the scope of the study
- participants suffering from periodontitis (pathological tooth mobility could falsify the study results)
- Maximal mouth opening less than 3.5 cm
- participants who wear large reconstructive works and/or have a free-end situation from at least the 2nd premolar
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Zurich, Center for Dental Medicine
Zurich, 8032
About this study
Official title: In Vivo Accuracy of Digital Intraoral Scans/Optical Impression Systems for the Production of Full-Arch Impressions
For several decades now, modern procedures have allowed dentists to capture your teeth using digital cameras. This digital procedure is increasingly replacing traditional impressions with a viscous mass that hardens in the mouth.
In the following study, the investigators want to find out whether the accuracy of these modern methods is comparable to the classic impression technique.
Three conventional impressions are taken for this purpose, and multiple digital impressions are also taken with each of the intraoral scanners. The impressions are then compared with each other. This allows the accuracy of the different intraoral scanners to be determined.
Read the detailed description
In summary, this study intends to address the need for comprehensive in vivo research on the accuracy of intraoral impression methods, especially in the context of modern digital technologies. By comparing various digital and conventional methods, this research will offer valuable information to guide dental practitioners in choosing the most precise and reliable techniques for their clinical applications.
The following study design is planned:
The study is non-randomised. The study setup is monocentric. At the beginning of the session, 3 conventional impression each of the upper and lower jaw is taken. After 8 hours the impression is moulded by a dental technician with a SuperHard plaster (type 4).After 48 hours of setting time the plaster-model is scanned with a lab scanner (inEos X5, Dentsply Sirona) to generate a .stl-file that is comparable to the following digital impressions.
This is followed by 6 digital impressions of the upper and lower jaw and the associated bite registration in habitual occlusion, divided between two experienced practitioners (3 upper, 3 lower jaw scans, 3 bite registrations per practitioner) with the 8 different intra oral scanners. In total, 6 conventional (3 upper, 3 lower jaw impressions), 48 digital impressions and 48 bite registration are taken. If it is not possible to take all the impressions in one session, a new conventional impression is taken at the start of each new session, so that a daily updated reference model is always available. Minimizing bias is achieved, by using the intra oral scanners according to the manufacturers instructions.
The number of scans was calculated as part of a power analysis based on previous study results and should therefore be meaningful.
The selection of scanners represents a heterogeneous selection of devices currently on the market. The scanners come from different price categories and use different optical measuring principles.
The precision measurement is carried out by comparing the impressions within and between the tested groups (precision and trueness respectively). For that, the scans will be exported to STL \& PLY format (depending on the scanning device) and imported into evaluation programs (Dentexion, Dentexion and Control X, Geomagic). The evaluation process follows the ISO 5725-1 criteria. After superimposition of the mesh surfaces according to the best-fit alignment, the distances will be measured point-to-point using the signed nearest neighbor method and sorted into a histogram. From that, the distance measure for each pairwise surface superimposition will be calculated from the (90%-10%)/2 percentile value.
- Conditions
- Full-arch Impression
- Being tested
- impression of the teeth
- Keywords
- accuracy, intra oral scan, full-arch impression, conventional and optical impression of the teeth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
impression of the teethDiagnostic test
Only conventional and digital impressions (comparable with taking videography) are taken of the patients teeth.
| Study group | Role | What they receive |
|---|---|---|
| Comparison conventional impression vs. digital impression | Other | The investigators would like to investigate the accuracy of various intraoral scanning systems. For this a conventional impression is taken from all patients to generate a reference model, which is then compared to full-arch impressions from various digital intraoral scanning systems.
The examination is carried out in the same way for all participants. Receives: Diagnostic Test: impression of the teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy measurement of digital impressions performed with optical impression systems are primary endpoints
The accuracy of the intraoral scanners (primary endpoint) is analyzed on the basis of precision and trueness. The unit of measure used is the same (μm).
The trueness of each test group is assessed by superimposing each scan with the reference model data set. The precision is calculated as the mean difference between all superimpositions within one test group.
Measured: It is intended that all impressions take place within half a day, the accuracy measurement should be carried out within 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start28 Oct 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Full-arch ImpressionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658366
- Sponsor's protocol ID
- 2024-00618
- Status last verified
- Jun 2025
- First submitted
- 25 Jul 2024
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The ethics application, which has already been approved, contains clear provisions on data protection. There is no provision for data to be passed on; accordingly, the investigators must protect all personal data and may not pass it on to third parties.
Publications
Ender A, Attin T, Mehl A. In vivo precision of conventional and digital methods of obtaining complete-arch dental impressions. J Prosthet Dent. 2016 Mar;115(3):313-20. doi: 10.1016/j.prosdent.2015.09.011. Epub 2015 Nov 6.
PubMed 26548890
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Accuracy of Digital Intraoral Scans/Optical Impression Systems for the Production of Full-Arch Impressions
- ClinicalTrials.gov ID
- NCT06658366
- Acronym / sponsor ID
- 2024-00618
- Conditions
- Full-arch Impression
- Keywords
- accuracy, intra oral scan, full-arch impression, conventional and optical impression of the teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 26 Oct 2024 (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.
For several decades now, modern procedures have allowed dentists to capture your teeth using digital cameras. This digital procedure is increasingly replacing traditional impressions with a viscous mass that hardens in the mouth.
In the following study, the investigators want to find out whether the accuracy of these modern methods is comparable to the classic impression technique.
Three conventional impressions are taken for this purpose, and multiple digital impressions are also taken with each of the intraoral scanners. The impressions are then compared with each other. This allows the accuracy of the different intraoral scanners to be determined.
Detailed description
In summary, this study intends to address the need for comprehensive in vivo research on the accuracy of intraoral impression methods, especially in the context of modern digital technologies. By comparing various digital and conventional methods, this research will offer valuable information to guide dental practitioners in choosing the most precise and reliable techniques for their clinical applications.
The following study design is planned:
The study is non-randomised. The study setup is monocentric. At the beginning of the session, 3 conventional impression each of the upper and lower jaw is taken. After 8 hours the impression is moulded by a dental technician with a SuperHard plaster (type 4).After 48 hours of setting time the plaster-model is scanned with a lab scanner (inEos X5, Dentsply Sirona) to generate a .stl-file that is comparable to the following digital impressions.
This is followed by 6 digital impressions of the upper and lower jaw and the associated bite registration in habitual occlusion, divided between two experienced practitioners (3 upper, 3 lower jaw scans, 3 bite registrations per practitioner) with the 8 different intra oral scanners. In total, 6 conventional (3 upper, 3 lower jaw impressions), 48 digital impressions and 48 bite registration are taken. If it is not possible to take all the impressions in one session, a new conventional impression is taken at the start of each new session, so that a daily updated reference model is always available. Minimizing bias is achieved, by using the intra oral scanners according to the manufacturers instructions.
The number of scans was calculated as part of a power analysis based on previous study results and should therefore be meaningful.
The selection of scanners represents a heterogeneous selection of devices currently on the market. The scanners come from different price categories and use different optical measuring principles.
The precision measurement is carried out by comparing the impressions within and between the tested groups (precision and trueness respectively). For that, the scans will be exported to STL \& PLY format (depending on the scanning device) and imported into evaluation programs (Dentexion, Dentexion and Control X, Geomagic). The evaluation process follows the ISO 5725-1 criteria. After superimposition of the mesh surfaces according to the best-fit alignment, the distances will be measured point-to-point using the signed nearest neighbor method and sorted into a histogram. From that, the distance measure for each pairwise surface superimposition will be calculated from the (90%-10%)/2 percentile value.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comparison conventional impression vs. digital impression | Other | Diagnostic Test: impression of the teethThe investigators would like to investigate the accuracy of various intraoral scanning systems. For this a conventional impression is taken from all patients to generate a reference model, which is then compared to full-arch impressions from various digital intraoral scanning systems. The examination is carried out in the same way for all participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All genders, minimum age for participation is 18 years
- Good general health and healthy dental conditions (gaps with a maximum of 1 missing tooth are permitted)
- Written consent after informed consent discussion is available
Key exclusion criteria (5 listed)
- participants under the age of 18
- Addicts or participants with impaired cognitive abilities that do not allow the participant to assess the scope of the study
- participants suffering from periodontitis (pathological tooth mobility could falsify the study results)
- Maximal mouth opening less than 3.5 cm
- participants who wear large reconstructive works and/or have a free-end situation from at least the 2nd premolar
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 |
|---|---|---|
| impression of the teethOnly conventional and digital impressions (comparable with taking videography) are taken of the patients teeth. | Diagnostic test | Comparison conventional impression vs. digital impression |
Primary outcome
Accuracy measurement of digital impressions performed with optical impression systems are primary endpoints
Time frame: It is intended that all impressions take place within half a day, the accuracy measurement should be carried out within 6 weeks.
The accuracy of the intraoral scanners (primary endpoint) is analyzed on the basis of precision and trueness. The unit of measure used is the same (μm). The trueness of each test group is assessed by superimposing each scan with the reference model data set. The precision is calculated as the mean difference between all superimpositions within one test group.
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 26 Jan 2026.
- Results publication: PubMed 26548890Ender A, Attin T, Mehl A. In vivo precision of conventional and digital methods of obtaining complete-arch dental impressions. J Prosthet Dent. 2016 Mar;115(3):313-20. doi: 10.1016/j.prosdent.2015.09.011. Epub 2015 Nov 6.
- Individual participant dataSharing planned: No. The ethics application, which has already been approved, contains clear provisions on data protection. There is no provision for data to be passed on; accordingly, the investigators must protect all personal data and may not pass it on to third parties.
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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?
A study testing impression of the teeth in people with Full-arch Impression, run by University of Zurich at 1 site in Switzerland.
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 3 inclusion and 5 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 26 Jan 2026. 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 Switzerland. 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?
Accuracy measurement of digital impressions performed with optical impression systems are primary endpoints (time frame: It is intended that all impressions take place within half a day, the accuracy measurement should be carried out within 6 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06658366, which also lists 1 linked publication.
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 26 Jan 2026.