Prosthesis User, DigitalismNCT07466355
Evaluation of Implant Abutment-Level Digitalization Techniques
A study testing Digital workflows using an intraoral scanner (TRIOS, 3Shape) in people with Prosthesis User, Digitalism, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This methodological clinical study aims to evaluate digital workflows used for the intraoral digitalization of cement-retained implant abutments in situations where implant impression components are unavailable and abutment replacement is not feasible. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prosthesis User, Digitalism
- What is being tested?
- Digital workflows using an intraoral scanner (TRIOS, 3Shape)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Mar 2025to 14 Oct 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Voluntary participation in the study after reading and signing the informed consent form 2. Adult patient over the age of 18 who has completed growth and development 3. Having healthy dental and periodontal conditions 4. Presence of partial edentulism in the functional region requiring two-implant-supported restorations with two or three occlusal units 5. Having a fixed dentition in the arch with edentulism 6. Having a fixed dentition in the opposing arch 7. No need for vertical or horizontal prosthetic correction in the interarch occlusal relationship 8. Presence of bone-level implants placed with "straightforward" surgical approach (as defined by the SAC classification system [195]), without advanced surgical techniques
- -
Who cannot join
- 1. Refusal to participate voluntarily in the study after reading the informed consent form 2. Presence of any absolute contraindication to implant treatment (e.g., history of radiation therapy, bone cancer, metabolic disorders) 3. Presence of systemic risk factors for implant treatment (e.g., steroid therapy, uncontrolled diabetes, immunological disorders, pregnancy) 4. Presence of local risk factors for implant treatment (e.g., periodontal disease, bruxism, poor oral hygiene) 5. Presence of temporomandibular joint disorders that limit jaw movements
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Dentistry Department of Prosthodontics
Ankara, 06230
About this study
Official title: Evaluation of Implant Abutment Level Digitalization Techniques: A Clinical Methodological Study
This methodological clinical study aims to evaluate digital workflows used for the intraoral digitalization of cement-retained implant abutments in situations where implant impression components are unavailable and abutment replacement is not feasible. Three digital impression workflows were compared through quantitative analysis of three-dimensional implant positions derived from digital datasets obtained using scan bodies and abutment-level scans. Implant positions were defined by virtual implant axes and analyzed using reverse engineering software. The study evaluates whether combined intraoral-extraoral abutment scanning provides comparable accuracy to direct intraoral abutment scanning.
Read the detailed description
Digital workflows have increasingly been integrated into implant prosthodontics through the use of intraoral scanners and CAD-CAM technologies. While scan bodies are considered the gold standard for transferring implant position digitally, clinical situations may arise in which implant impression components are unavailable or replacement of the existing abutment is not feasible. In such scenarios, direct intraoral digitalization of the existing implant abutment has been proposed as an alternative method for capturing implant position during prosthetic maintenance or restoration replacement. However, the accuracy and clinical reliability of abutment-level digitalization remain uncertain.
The aim of this methodological clinical study is to compare different digital workflows for the intraoral digitalization of cement-retained implant abutments in clinical conditions where conventional implant impression components cannot be used. Three digital impression workflows were evaluated by comparing three-dimensional implant positions obtained from digital datasets. Implant positions were defined by virtual implant axes derived from scan body data and abutment-level scans, and analyzed using reverse engineering software.
- Conditions
- Prosthesis User, Digitalism
- Being tested
- Digital workflows using an intraoral scanner (TRIOS, 3Shape)
- Keywords
- digital dentistry, intraoral scanner, cement-retained abutment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital workflows using an intraoral scanner (TRIOS, 3Shape)Other
Also called Straumann (CARES Mono Scanbody; Straumann Holding AG, ), Straumann ( Bone Level Cementable Abutment; Straumann Holding AG) ,3Shape (3Shape A/S, Copenhagen, Denmark)
In this clinical study, three digital workflows were applied to each participant for the digitalization of cement-retained implant abutments. All digital impressions were obtained using an intraoral scanner (TRIOS, 3Shape). The workflows included: (1) intraoral scanning using the original scan body (Straumann), (2) direct intraoral scanning of the cement-retained abutment, and (3) a combined workflow involving intraoral and extraoral scanning of the abutment followed by best-fit alignment. Three-dimensional implant positions were defined by virtual implant axes derived from the digital datasets. Angular deviation analysis was performed using reverse engineering software to compare implant position outcomes among the digital workflows.
| Study group | Role | What they receive |
|---|---|---|
| Comparison of Different Digital Workflows | Experimental | In this clinical study, three different digital workflows were applied sequentially to the same group of participants for the digitalization of cement-retained implant abutments. The workflows included: (1) direct intraoral scanning using a scan body, (2) direct intraoral scanning of the cement-retained abutment, and (3) a combined workflow involving intraoral and extraoral scanning of the abutment followed by best-fit alignment. Three-dimensional implant positions were defined by virtual implant axes derived from the digital datasets. Angular deviation analysis was performed using reverse engineering software to compare implant position outcomes among the workflows. Receives: Other: Digital workflows using an intraoral scanner (TRIOS, 3Shape) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angular deviation of virtual implant axes among digital workflows
Deviation of implant positions defined by virtual implant axes derived from digital datasets obtained using different digital impression workflows and analyzed using reverse engineering software.
Measured: Immediately after digital model analysis.
Secondary outcomes (1)
Angular deviation of virtual implant axes
Angular deviation between virtual implant axes derived from scan body datasets and abutment-level digital datasets generated through different digital workflows.
Measured: Immediately after digital model analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start21 Mar 2025
- Primary completion29 Sep 2025
- Study completion14 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prosthesis User, DigitalismStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kıvanç Akça, Hacettepe University
- Investigators
- Kıvanç Akça, DDS, PhD, Study director, Hacettepe University, Faculty of Dentistry, Department of Prosthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466355
- Sponsor's protocol ID
- KA-24057
- Status last verified
- Jan 2026
- First submitted
- 4 Mar 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared for this study.
Publications
Cho WT, Bae EB, Ahn JJ, Huh JB. Cordless digital workflow for scanning implant-supported prostheses at the abutment level: A dental technique. J Prosthet Dent. 2020 Oct;124(4):428-430. doi: 10.1016/j.prosdent.2019.11.003. Epub 2020 Jan 7.
PubMed 31918894Sancho-Puchades M, Crameri D, Ozcan M, Sailer I, Jung RE, Hammerle CHF, Thoma DS. The influence of the emergence profile on the amount of undetected cement excess after delivery of cement-retained implant reconstructions. Clin Oral Implants Res. 2017 Dec;28(12):1515-1522. doi: 10.1111/clr.13020. Epub 2017 Apr 13.
PubMed 28407306
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Implant Abutment Level Digitalization Techniques: A Clinical Methodological Study
- ClinicalTrials.gov ID
- NCT07466355
- Acronym / sponsor ID
- KA-24057
- Conditions
- Prosthesis User, Digitalism
- Keywords
- digital dentistry, intraoral scanner, cement-retained abutment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 14 Oct 2025 (actual)
- First posted
- 12 Mar 2026 (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.
This methodological clinical study aims to evaluate digital workflows used for the intraoral digitalization of cement-retained implant abutments in situations where implant impression components are unavailable and abutment replacement is not feasible. Three digital impression workflows were compared through quantitative analysis of three-dimensional implant positions derived from digital datasets obtained using scan bodies and abutment-level scans. Implant positions were defined by virtual implant axes and analyzed using reverse engineering software. The study evaluates whether combined intraoral-extraoral abutment scanning provides comparable accuracy to direct intraoral abutment scanning.
Detailed description
Digital workflows have increasingly been integrated into implant prosthodontics through the use of intraoral scanners and CAD-CAM technologies. While scan bodies are considered the gold standard for transferring implant position digitally, clinical situations may arise in which implant impression components are unavailable or replacement of the existing abutment is not feasible. In such scenarios, direct intraoral digitalization of the existing implant abutment has been proposed as an alternative method for capturing implant position during prosthetic maintenance or restoration replacement. However, the accuracy and clinical reliability of abutment-level digitalization remain uncertain.
The aim of this methodological clinical study is to compare different digital workflows for the intraoral digitalization of cement-retained implant abutments in clinical conditions where conventional implant impression components cannot be used. Three digital impression workflows were evaluated by comparing three-dimensional implant positions obtained from digital datasets. Implant positions were defined by virtual implant axes derived from scan body data and abutment-level scans, and analyzed using reverse engineering software.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comparison of Different Digital Workflows | Experimental | Other: Digital workflows using an intraoral scanner (TRIOS, 3Shape)In this clinical study, three different digital workflows were applied sequentially to the same group of participants for the digitalization of cement-retained implant abutments. The workflows included: (1) direct intraoral scanning using a scan body, (2) direct intraoral scanning of the cement-retained abutment, and (3) a combined workflow involving intraoral and extraoral scanning of the abutment followed by best-fit alignment. Three-dimensional implant positions were defined by virtual implant axes derived from the digital datasets. Angular deviation analysis was performed using reverse engineering software to compare implant position outcomes among the workflows. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Voluntary participation in the study after reading and signing the informed consent form 2. Adult patient over the age of 18 who has completed growth and development 3. Having healthy dental and periodontal conditions 4. Presence of partial edentulism in the functional region requiring two-implant-supported restorations with two or three occlusal units 5. Having a fixed dentition in the arch with edentulism 6. Having a fixed dentition in the opposing arch 7. No need for vertical or horizontal prosthetic correction in the interarch occlusal relationship 8. Presence of bone-level implants placed with "straightforward" surgical approach (as defined by the SAC classification system [195]), without advanced surgical techniques
- -
Key exclusion criteria (2 listed)
- 1. Refusal to participate voluntarily in the study after reading the informed consent form 2. Presence of any absolute contraindication to implant treatment (e.g., history of radiation therapy, bone cancer, metabolic disorders) 3. Presence of systemic risk factors for implant treatment (e.g., steroid therapy, uncontrolled diabetes, immunological disorders, pregnancy) 4. Presence of local risk factors for implant treatment (e.g., periodontal disease, bruxism, poor oral hygiene) 5. Presence of temporomandibular joint disorders that limit jaw movements
- -
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 |
|---|---|---|
| Digital workflows using an intraoral scanner (TRIOS, 3Shape)Also: Straumann (CARES Mono Scanbody; Straumann Holding AG, ), Straumann ( Bone Level Cementable Abutment; Straumann Holding AG) ,3Shape (3Shape A/S, Copenhagen, Denmark)In this clinical study, three digital workflows were applied to each participant for the digitalization of cement-retained implant abutments. All digital impressions were obtained using an intraoral scanner (TRIOS, 3Shape). The workflows included: (1) intraoral scanning using the original scan body (Straumann), (2) direct intraoral scanning of the cement-retained abutment, and (3) a combined workflow involving intraoral and extraoral scanning of the abutment followed by best-fit alignment. Three-dimensional implant positions were defined by virtual implant axes derived from the digital datasets. Angular deviation analysis was performed using reverse engineering software to compare implant position outcomes among the digital workflows. | Other | Comparison of Different Digital Workflows |
Primary outcome
Angular deviation of virtual implant axes among digital workflows
Time frame: Immediately after digital model analysis.
Deviation of implant positions defined by virtual implant axes derived from digital datasets obtained using different digital impression workflows and analyzed using reverse engineering software.
1 secondary outcome
Angular deviation of virtual implant axes
Time frame: Immediately after digital model analysis.
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 2 Sep 2026.
- Background: PubMed 31918894Cho WT, Bae EB, Ahn JJ, Huh JB. Cordless digital workflow for scanning implant-supported prostheses at the abutment level: A dental technique. J Prosthet Dent. 2020 Oct;124(4):428-430. doi: 10.1016/j.prosdent.2019.11.003. Epub 2020 Jan 7.
- Background: PubMed 28407306Sancho-Puchades M, Crameri D, Ozcan M, Sailer I, Jung RE, Hammerle CHF, Thoma DS. The influence of the emergence profile on the amount of undetected cement excess after delivery of cement-retained implant reconstructions. Clin Oral Implants Res. 2017 Dec;28(12):1515-1522. doi: 10.1111/clr.13020. Epub 2017 Apr 13.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared for this study.
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.
Kıvanç Akça, DDS, PhD study director
Hacettepe University, Faculty of Dentistry, Department of Prosthodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital workflows using an intraoral scanner (TRIOS, 3Shape) in people with Prosthesis User, Digitalism, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 2 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 2 Sep 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 Turkey (Türkiye). 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?
Angular deviation of virtual implant axes among digital workflows (time frame: Immediately after digital model analysis.). 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 NCT07466355, which also lists 2 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 2 Sep 2026; AzTrials last refreshed its copy on 29 Oct 2026.