Evaluation of Implant Abutment-Level Digitalization Techniques

March 9, 2026 updated by: Kıvanç Akça, Hacettepe University

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey (Türkiye), 06230
        • Hacettepe University Faculty of Dentistry Department of Prosthodontics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

-

Exclusion Criteria:

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Comparison of Different Digital Workflows
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.
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 Names:
  • Straumann (CARES Mono Scanbody; Straumann Holding AG, ), Straumann ( Bone Level Cementable Abutment; Straumann Holding AG) ,3Shape (3Shape A/S, Copenhagen, Denmark)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after digital model analysis.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Angular deviation of virtual implant axes
Time Frame: Immediately after digital model analysis.
Angular deviation between virtual implant axes derived from scan body datasets and abutment-level digital datasets generated through different digital workflows.
Immediately after digital model analysis.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Kıvanç Akça, DDS, PhD, Hacettepe University, Faculty of Dentistry, Department of Prosthodontics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2025

Primary Completion (Actual)

September 29, 2025

Study Completion (Actual)

October 14, 2025

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • KA-24057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared for this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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