Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
16 participants
OBSERVATIONAL
2022-07-01
2023-12-31
Brief Summary
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With respect to both edentulous and edentulous patients with dental implants, the currently available literature does not provide a firm basis for deciding whether such patients can already be scanned with sufficient accuracy. It is considered problematic in this context that the findings on digital impression accuracy, regardless of whether teeth or implants have been scanned, are based almost exclusively on the results of in vitro studies. Conclusions about the accuracy of intraoral scanners under clinical conditions with moving patients and limited accessibility to the structures to be imaged, especially in the presence of blood, saliva or sulcus fluid, are extremely limited based on these data.
Therefore, the aim of this study is to determine the clinical scanning accuracy of two current intraoral scanning systems for the three-dimensional acquisition of the position of two interforaminal dental implants in the edentulous mandible. The influence of artificial landmarks to achieve increased scan accuracy will also be tested.
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Locator Group
The participant has a mandibular overdenture supported by two implants with locator attachments. The implants are scanned with each of two intraoral scanners both with and without the use of artificial landmarks. The implant scans are analyzed in terms of scanning accuracy (trueness and precision) by comparison with a reference model (3D implant positions in the working cast of the immediately loaded overdenture).
No interventions assigned to this group
Bar Group
The participant has a mandibular overdenture supported by two implants with a dolder bar attachment. The implants are scanned with each of two intraoral scanners both with and without the use of artificial landmarks. The implant scans are analyzed in terms of scanning accuracy (trueness and precision) by comparison with a reference model (3D implant positions in the working cast of the immediately loaded overdenture).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Participant is legally capable
* Signed informed consent form available
Exclusion Criteria
* Participant not willing to participate
* New overdenture or dolder bar attachment based on a working cast other than that used for immediate loading
* No intact working casts available
* Diagnosed epilepsy
* Pregnancy and lactation
* Local or systemic acute or chronic (also in the past) general medical diseases and conditions, which contradict a participation in the study and or expose the patient to a higher risk in case of a study participation
* Known allergies or intolerances to the materials used in the study.
* Lack of compliance
18 Years
100 Years
ALL
No
Sponsors
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University Hospital Heidelberg
OTHER
Responsible Party
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Dr. Wolfgang Bömicke
Principal Investigator
Principal Investigators
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Wolfgang Bömicke, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Prosthetic Dentistry, University of Heidelberg
Locations
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Department of Prosthetic Dentistry, University Hospital Heidelberg, University of Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Countries
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Other Identifiers
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ZI²
Identifier Type: -
Identifier Source: org_study_id
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