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Completed

NCT Number: NCT07466355

Evaluation of Implant Abutment-Level Digitalization Techniques

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University Faculty of Dentistry Department of Prosthodontics

Ankara, 06230, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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Exclusion criteria

  • 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

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Treatment and study plan

Digital workflows using an intraoral scanner (TRIOS, 3Shape)

Other

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Evaluation of Implant Abutment Level Digitalization Techniques: A Clinical Methodological Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.