Maxillary Complete-arch Digital Scans for Implant-supported OverdenturesNCT07295899
Assessing the Influence of Implant Scanning Techniques on the Accuracy of Maxillary Complete-Arch Digital Scans for Implant Overdentures: A Comparative Clinical Study
An observational study of Maxillary Complete-arch Digital Scans for Implant-supported Overdentures, run by National and Kapodistrian University of Athens.
Trial summary
Recently different protocols have been developed for the implementation of intraoral scanning in full-arch implant workflows, as horizontal scan body scanning, 1 reverse scanning 2 and scan body systems with an integrated verification jig 3 . Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Maxillary Complete-arch Digital Scans for Implant-supported Overdentures
- What is being tested?
- Intraoral scanning
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 15 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Dental clinical patients
Who may be able to join
- 4 implants places in fully edentelous patient that is planned to be treated with implant supported overdenture
- -
Who cannot join
- Diseases / Conditions That Can Contraindicate Dental Treatment
- Uncontrolled Systemic Conditions
- Dental procedures-especially invasive ones-are often postponed if the condition is not medically stable:
- Uncontrolled Hypertension
- BP typically >180/110 mmHg is considered unsafe for elective dental care.
- Risk: stroke, heart attack during treatment.
Show all 46Show fewer
- Uncontrolled Diabetes
- High blood glucose (e.g., >300 mg/dL) increases infection risk and poor healing.
- Uncontrolled Thyroid Disease
- Hyperthyroidism raises risk of thyroid storm, especially with epinephrine.
- Recent Major Cardiac Events
- Elective dental treatment is usually deferred for:
- Heart attack (MI) within past 6 months
- Stroke within past 6 months
- Unstable angina
- Severe arrhythmias
- Decompensated heart failure
- These conditions can make dental stress or anesthesia dangerous.
- Infectious Diseases (Active Phase)
- Dental treatment may be delayed to protect the patient or others.
- Active Herpetic Lesions (Cold Sores) around the mouth
- Active Tuberculosis (TB)
- COVID-19 or other acute respiratory infections with fever
- Hematologic Disorders
- If blood does not clot properly, dental surgery can be risky.
- Severe Thrombocytopenia
- Platelets too low for safe extraction or surgery.
- Hemophilia or bleeding disorders
- Require management with a hematologist first.
- Patients on certain anticoagulants (e.g., warfarin with very high INR)
- May need medical adjustment before invasive care.
- Pregnancy (Certain Situations)
- Most dental care is safe, but some procedures are postponed:
- Elective treatments during 1st trimester
- Avoid certain medications (e.g., some anesthetics, antibiotics, NSAIDs)
- Severe hypertension or pregnancy complications (eclampsia)
- Severe Psychiatric Conditions (Unstable)
- When a patient cannot cooperate safely:
- Acute psychosis
- Severe anxiety uncontrolled by medication
- Need medical stabilization vs. dental sedation coordination
- Substance Intoxication
- Dental care is not performed if patient is intoxicated with:
- Alcohol
- Recreational drugs (especially stimulants like cocaine or meth)
- Risk of cardiovascular events or inability to consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Impact of Implant Scanning Technique on the Accuracy of Maxillary Complete-arch Digital Scans for Implant-supported Overdentures
Recently different protocols have been developed for the implementation of intraoral scanning in full-arch implant workflows, as horizontal scan body scanning, 1 reverse scanning 2 and scan body systems with an integrated verification jig 3 . The aforementioned approaches are aiming to reduce the inaccuracies related with the implementation of intraoral scanners in full-arch implant cases and to improve the efficiency of the whole digital workflow. However the efficiency of these methods and the parameters that can influence their accuracy, as the design of the scan body have not been investigated.
The purpose of the present in vivo study is to compare the trueness and the precision of the recorded implant's position, between conventional and novel implant acquisition protocols.
Read the detailed description
The collection of the clinical data for the present research is going to be performed in a private dental clinic.A single patient presenting with an edentulous maxillary arch will be enrolled in the present study.
The patient has to be treated with the placement of four implants and to be planned to be restored with an implant-supported overdenture.In total 3 different scan body systems are going to be evaluated in the present research: conventional scan-bodies (Cares Mono Scan body, Straumann), scan-bodies designed for a horizontal intraoral scanning (Apollo and Reference Scan body, Dynamic abutment), reverse scan bodies (ReveX, Straumann; Scanalog, Dynamic abutment) The scan-bodies will be hand-tightening over the multi-units, which previously will be fixed on 4 implants in patient's maxilla. Each one of the evaluated scan bodies is going to be scanned using an intraoral scanner Trios 5 (3Shape). The verified dentate scan path
recommended by the manufacturer is going to be followed, to scan the reference cast 10 times, for each one of the evaluated scan body systems. The digital scans for each group are going to be performed without removing the scan-bodies in order to eliminate the effect of scan body fit. Finally, an analog impression of splinted impression posts is going to be taken in order to serve as a reference. Based to the analog impression a reference cast is going to be fabricated using a plaster (Type 3, Moldano, Kulzer) and be scanned by a desktop scanner (T710, Medit) using laboratory scan bodies to serve as a reference.The STL files for each evaluated group along with the scans from the industrial scanner will be imported in a metrology software (Geomagic, control X). The digital model derived from each evaluated group is going to be superimposed with the model obtained from the industrial scanner respectively. In order to achieve an accurate superimposition, first "align between measured data" function will be utilized, followed by "best-fit alignment". During the alignment, the area of the scan bodies will be excluded, in order to prevent them from influencing the alignment and the subsequent evaluation. This will be accomplished by using the "use select data only" function. In order to standardize the aforementioned procedure, all superimposed models will be cut simultaneously in the same region.
Afterwards, the overall deviation will be calculated, by using "3D compare" function on Geomagic software, by creating a color map in superimposed digital models to qualitative analyze any 3D deviation. The color map is going to be ranged from -0.5mm to +0.5mm. Mean discrepancy is going to be measured in root mean square RMS, which is a mathematical measure of magnitude of a set of numbers. Trueness will be defined in terms of the mean discrepancy on the positions of the implant abutments, between the digitized by the industrial scanner reference cast and each evaluated group. Precision will be described as the standard deviation of the mean absolute discrepancies computed between the digitized by the industrial scanner reference cast and each evaluated group. A smaller SD indicates that measurements are more precise and consistent, while larger SD will imply greater variability.A power analysis was performed utilizing the G*Power software (G*Power, Heinrich- Heine-Universität Düsseldorf, Germany). The total sample size was calculated based on an effect size of 0.4, an alpha error probability of 0.05, a power of 0.8 and an estimated correlation between measurements of 0.5. The power analysis revealed that a minimum of 10 data sets per evaluated group is required to perform the present study. Statistical analysis will be performed using SPSS statistics software (version 29, IBM software).
Descriptive statistics will be calculated for each evaluated group. The Shapiro-Wilk test will be performed in order to test if the data are normally distributed (P\<0.05). For the trueness and the precision, post-hoc analysis (Tukey, Scheffe) will be conducted to assess which evaluated implant acquisition technique will be statistically significantly different.
Fisher's exact test will be used to assess the association between the implant acquisition method and the accuracy of the fit. The level of significance will be set at 0.05. The agreement of fit assessment between the two experienced clinicians will be tested with κ statistics (Cohen's k-score).
- Being tested
- Intraoral scanning
- Keywords
- Overdenture, Intraoral scanner, Accuracy, Implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoral scanningDevice
Different designs of scanbodies will be used
| Study group | Role | What they receive |
|---|---|---|
| Scan body (Conventional) | Not described Receives: Device: Intraoral scanning | |
| Scan body (Reverse design) | Not described Receives: Device: Intraoral scanning | |
| Scan body (Apollo design) | Not described Receives: Device: Intraoral scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear measurements
The difference in the linear position between the control and each investigation method would be calculated.
Measured: Through study completion, an average of 1 year, after the execution of all intraoral scans. (Cross-sectional)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion25 Dec 2025 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Maxillary Complete-arch Digital Scans for Implant-supported OverdenturesStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panagiotis Ntovas, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295899
- Sponsor's protocol ID
- 47/17.07.2025
- Status last verified
- Dec 2025
- First submitted
- 28 Nov 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu HK, Wang J, Chen G, Huang X, Deng F, Li Y. Effect of novel prefabricated auxiliary devices attaching to scan bodies on the accuracy of intraoral scanning of complete-arch with multiple implants: An in-vitro study. J Dent. 2023 Nov;138:104702. doi: 10.1016/j.jdent.2023.104702. Epub 2023 Sep 14.
PubMed 37714453Carneiro Pereira AL, Souza Curinga MR, Melo Segundo HV, da Fonte Porto Carreiro A. Factors that influence the accuracy of intraoral scanning of total edentulous arches rehabilitated with multiple implants: A systematic review. J Prosthet Dent. 2023 Jun;129(6):855-862. doi: 10.1016/j.prosdent.2021.09.001. Epub 2021 Oct 13.
PubMed 34656307Gomez-Polo M, Donmez MB, Cakmak G, Yilmaz B, Revilla-Leon M. Influence of implant scan body design (height, diameter, geometry, material, and retention system) on intraoral scanning accuracy: A systematic review. J Prosthodont. 2023 Dec;32(S2):165-180. doi: 10.1111/jopr.13774. Epub 2023 Oct 18.
PubMed 37771200Revilla-Leon M, Smith Z, Methani MM, Zandinejad A, Ozcan M. Influence of scan body design on accuracy of the implant position as transferred to a virtual definitive implant cast. J Prosthet Dent. 2021 Jun;125(6):918-923. doi: 10.1016/j.prosdent.2020.03.019. Epub 2020 May 31.
PubMed 32493568Papaspyridakos P, Bedrossian A, Kudara Y, Ntovas P, Bokhary A, Chochlidakis K. Reverse scan body: A complete digital workflow for prosthesis prototype fabrication. J Prosthodont. 2023 Jun;32(5):452-457. doi: 10.1111/jopr.13664. Epub 2023 Mar 3.
PubMed 36779654Giglio GD, Giglio AB, Tarnow DP. A Paradigm Shift Using Scan Bodies to Record the Position of a Complete Arch of Implants in a Digital Workflow. Int J Periodontics Restorative Dent. 2024;44(1):115-126. doi: 10.11607/prd.6733.
PubMed 37552170
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Impact of Implant Scanning Technique on the Accuracy of Maxillary Complete-arch Digital Scans for Implant-supported Overdentures
- ClinicalTrials.gov ID
- NCT07295899
- Acronym / sponsor ID
- 47/17.07.2025
- Keywords
- Overdenture, Intraoral scanner, Accuracy, Implants
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 25 Dec 2025 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 22 Dec 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.
Recently different protocols have been developed for the implementation of intraoral scanning in full-arch implant workflows, as horizontal scan body scanning, 1 reverse scanning 2 and scan body systems with an integrated verification jig 3 . The aforementioned approaches are aiming to reduce the inaccuracies related with the implementation of intraoral scanners in full-arch implant cases and to improve the efficiency of the whole digital workflow. However the efficiency of these methods and the parameters that can influence their accuracy, as the design of the scan body have not been investigated.
The purpose of the present in vivo study is to compare the trueness and the precision of the recorded implant's position, between conventional and novel implant acquisition protocols.
Detailed description
The collection of the clinical data for the present research is going to be performed in a private dental clinic.A single patient presenting with an edentulous maxillary arch will be enrolled in the present study.
The patient has to be treated with the placement of four implants and to be planned to be restored with an implant-supported overdenture.In total 3 different scan body systems are going to be evaluated in the present research: conventional scan-bodies (Cares Mono Scan body, Straumann), scan-bodies designed for a horizontal intraoral scanning (Apollo and Reference Scan body, Dynamic abutment), reverse scan bodies (ReveX, Straumann; Scanalog, Dynamic abutment) The scan-bodies will be hand-tightening over the multi-units, which previously will be fixed on 4 implants in patient's maxilla. Each one of the evaluated scan bodies is going to be scanned using an intraoral scanner Trios 5 (3Shape). The verified dentate scan path
recommended by the manufacturer is going to be followed, to scan the reference cast 10 times, for each one of the evaluated scan body systems. The digital scans for each group are going to be performed without removing the scan-bodies in order to eliminate the effect of scan body fit. Finally, an analog impression of splinted impression posts is going to be taken in order to serve as a reference. Based to the analog impression a reference cast is going to be fabricated using a plaster (Type 3, Moldano, Kulzer) and be scanned by a desktop scanner (T710, Medit) using laboratory scan bodies to serve as a reference.The STL files for each evaluated group along with the scans from the industrial scanner will be imported in a metrology software (Geomagic, control X). The digital model derived from each evaluated group is going to be superimposed with the model obtained from the industrial scanner respectively. In order to achieve an accurate superimposition, first "align between measured data" function will be utilized, followed by "best-fit alignment". During the alignment, the area of the scan bodies will be excluded, in order to prevent them from influencing the alignment and the subsequent evaluation. This will be accomplished by using the "use select data only" function. In order to standardize the aforementioned procedure, all superimposed models will be cut simultaneously in the same region.
Afterwards, the overall deviation will be calculated, by using "3D compare" function on Geomagic software, by creating a color map in superimposed digital models to qualitative analyze any 3D deviation. The color map is going to be ranged from -0.5mm to +0.5mm. Mean discrepancy is going to be measured in root mean square RMS, which is a mathematical measure of magnitude of a set of numbers. Trueness will be defined in terms of the mean discrepancy on the positions of the implant abutments, between the digitized by the industrial scanner reference cast and each evaluated group. Precision will be described as the standard deviation of the mean absolute discrepancies computed between the digitized by the industrial scanner reference cast and each evaluated group. A smaller SD indicates that measurements are more precise and consistent, while larger SD will imply greater variability.A power analysis was performed utilizing the G*Power software (G*Power, Heinrich- Heine-Universität Düsseldorf, Germany). The total sample size was calculated based on an effect size of 0.4, an alpha error probability of 0.05, a power of 0.8 and an estimated correlation between measurements of 0.5. The power analysis revealed that a minimum of 10 data sets per evaluated group is required to perform the present study. Statistical analysis will be performed using SPSS statistics software (version 29, IBM software).
Descriptive statistics will be calculated for each evaluated group. The Shapiro-Wilk test will be performed in order to test if the data are normally distributed (P\<0.05). For the trueness and the precision, post-hoc analysis (Tukey, Scheffe) will be conducted to assess which evaluated implant acquisition technique will be statistically significantly different.
Fisher's exact test will be used to assess the association between the implant acquisition method and the accuracy of the fit. The level of significance will be set at 0.05. The agreement of fit assessment between the two experienced clinicians will be tested with κ statistics (Cohen's k-score).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Scan body (Conventional) | – | Device: Intraoral scanning |
| Scan body (Reverse design) | – | Device: Intraoral scanning |
| Scan body (Apollo design) | – | Device: Intraoral scanning |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Dental clinical patients
Key inclusion criteria (2 listed)
- 4 implants places in fully edentelous patient that is planned to be treated with implant supported overdenture
- -
Key exclusion criteria (46 listed)
- Diseases / Conditions That Can Contraindicate Dental Treatment
- Uncontrolled Systemic Conditions
- Dental procedures-especially invasive ones-are often postponed if the condition is not medically stable:
- BP typically >180/110 mmHg is considered unsafe for elective dental care.
- Risk: stroke, heart attack during treatment.
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 |
|---|---|---|
| Intraoral scanningDifferent designs of scanbodies will be used | Device | Scan body (Apollo design), Scan body (Conventional), Scan body (Reverse design) |
Primary outcome
Linear measurements
Time frame: Through study completion, an average of 1 year, after the execution of all intraoral scans. (Cross-sectional)
The difference in the linear position between the control and each investigation method would be calculated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 37714453Wu HK, Wang J, Chen G, Huang X, Deng F, Li Y. Effect of novel prefabricated auxiliary devices attaching to scan bodies on the accuracy of intraoral scanning of complete-arch with multiple implants: An in-vitro study. J Dent. 2023 Nov;138:104702. doi: 10.1016/j.jdent.2023.104702. Epub 2023 Sep 14.
- Results publication: PubMed 34656307Carneiro Pereira AL, Souza Curinga MR, Melo Segundo HV, da Fonte Porto Carreiro A. Factors that influence the accuracy of intraoral scanning of total edentulous arches rehabilitated with multiple implants: A systematic review. J Prosthet Dent. 2023 Jun;129(6):855-862. doi: 10.1016/j.prosdent.2021.09.001. Epub 2021 Oct 13.
- Results publication: PubMed 37771200Gomez-Polo M, Donmez MB, Cakmak G, Yilmaz B, Revilla-Leon M. Influence of implant scan body design (height, diameter, geometry, material, and retention system) on intraoral scanning accuracy: A systematic review. J Prosthodont. 2023 Dec;32(S2):165-180. doi: 10.1111/jopr.13774. Epub 2023 Oct 18.
- Results publication: PubMed 32493568Revilla-Leon M, Smith Z, Methani MM, Zandinejad A, Ozcan M. Influence of scan body design on accuracy of the implant position as transferred to a virtual definitive implant cast. J Prosthet Dent. 2021 Jun;125(6):918-923. doi: 10.1016/j.prosdent.2020.03.019. Epub 2020 May 31.
- Results publication: PubMed 36779654Papaspyridakos P, Bedrossian A, Kudara Y, Ntovas P, Bokhary A, Chochlidakis K. Reverse scan body: A complete digital workflow for prosthesis prototype fabrication. J Prosthodont. 2023 Jun;32(5):452-457. doi: 10.1111/jopr.13664. Epub 2023 Mar 3.
- Results publication: PubMed 37552170Giglio GD, Giglio AB, Tarnow DP. A Paradigm Shift Using Scan Bodies to Record the Position of a Complete Arch of Implants in a Digital Workflow. Int J Periodontics Restorative Dent. 2024;44(1):115-126. doi: 10.11607/prd.6733.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Maxillary Complete-arch Digital Scans for Implant-supported Overdentures, run by National and Kapodistrian University of Athens.
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 2 inclusion and 46 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: opening soon, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Panagiotis Ntovas, DDS, MSc (+306985122220, pan.ntovas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear measurements (time frame: Through study completion, an average of 1 year, after the execution of all intraoral scans. (Cross-sectional)). 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 NCT07295899, which also lists 6 linked publications.
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 22 Dec 2025.