- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07466355
Evaluation of Implant Abutment-Level Digitalization Techniques
Evaluation of Implant Abutment Level Digitalization Techniques: A Clinical Methodological Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey (Türkiye), 06230
- Hacettepe University Faculty of Dentistry Department of Prosthodontics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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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
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Study Plan
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 |
|---|---|
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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.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Angular deviation of virtual implant axes among digital workflows
Time Frame: Immediately after digital model analysis.
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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.
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Immediately after digital model analysis.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Angular deviation of virtual implant axes
Time Frame: Immediately after digital model analysis.
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Angular deviation between virtual implant axes derived from scan body datasets and abutment-level digital datasets generated through different digital workflows.
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Immediately after digital model analysis.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Kıvanç Akça, DDS, PhD, Hacettepe University, Faculty of Dentistry, Department of Prosthodontics
Publications and helpful links
General 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.
- Sancho-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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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