Intraoral Scanning Accuracy in the Edentulous Mandible

May 7, 2024 updated by: Dr. Wolfgang Bömicke, University Hospital Heidelberg

In Vivo Accuracy of Two Intraoral Scanning Systems in Detecting Two Inter-foraminal Implants in the Edentulous Mandible.

Today, tooth- or implant-supported single crowns and short-span fixed partial dentures can be fabricated on the basis of an intraoral scan, but the scanning accuracy decreases with increasing length of the jaw section to be captured. An accurate scan is also made more difficult by edentulous jaw sections, as these provide the scanner with few landmarks for proper three-dimensional image composition.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

16

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

  • Germany
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • Department of Prosthetic Dentistry, University Hospital Heidelberg, University of Heidelberg

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

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Participants had received a mandibular overdenture supported by two implants with either Locator attachments or a Dodler bar attachment following an immediate loading protocol as part of a randomized controlled trial [Kappel S, Giannakopoulos NN, Eberhard L, Rammelsberg P, Eiffler C. Immediate Loading of Dental Implants in Edentulous Mandibles by Use of Locator® Attachments or Dolder® Bars: Two-Year Results from a Prospective Randomized Clinical Study. Clin Implant Dent Relat Res. 2016 Aug;18(4):752-61. doi: 10.1111/cid.12349. Epub 2015 May 7. PMID: 25950679.].

Description

Inclusion Criteria:

  • Participants who had received a mandibular overdenture supported by two implants with either Locator attachments or a Dodler bar attachment following an immediate loading protocol as part of a randomized controlled trial [Kappel S, Giannakopoulos NN, Eberhard L, Rammelsberg P, Eiffler C. Immediate Loading of Dental Implants in Edentulous Mandibles by Use of Locator® Attachments or Dolder® Bars: Two-Year Results from a Prospective Randomized Clinical Study. Clin Implant Dent Relat Res. 2016 Aug;18(4):752-61. doi: 10.1111/cid.12349. Epub 2015 May 7. PMID: 25950679.] and for whom intact working casts with laboratory implant analogs representing the reference implant positions were available.
  • Participant is legally capable
  • Signed informed consent form available

Exclusion Criteria:

  • Participant not contactable
  • 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

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

Cohorts and Interventions

Group / Cohort
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).
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of intraoral scanner on scanning accuracy
Time Frame: through study completion, an average of 2 hours
Accuracy will be given as trueness and precision according to ISO 20896-1:2019 Dentistry - Digital impression devices - Part 1: Methods for assessing accuracy. Implant distance deviations will be measured in [µm] and implant angle deviations in [°].
through study completion, an average of 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of artificial landmarks on scanning accuracy
Time Frame: through study completion, an average of 2 hours
Accuracy will be given as trueness and precision according to ISO 20896-1:2019 Dentistry - Digital impression devices - Part 1: Methods for assessing accuracy. Implant distance deviations will be measured in [µm] and implant angle deviations in [°].
through study completion, an average of 2 hours
Effect of implant attachment on scanning accuracy in [µm] and [°]
Time Frame: through study completion, an average of 2 hours
Accuracy will be given as trueness and precision according to ISO 20896-1:2019 Dentistry - Digital impression devices - Part 1: Methods for assessing accuracy. Implant distance deviations will be measured in [µm] and implant angle deviations in [°].
through study completion, an average of 2 hours
Effect of intraoral scanner/use of artificial landmarks on intraoral scanning process/quality of the 3D dataset by a study investigator on the basis of qualitative criteria (see description)
Time Frame: through study completion, an average of 2 hours
Effect of intraoral scanner/use of artificial landmarks on intraoral scanning process (successful, successful with difficulties, failed)/quality of the 3D dataset (Surface irregularities, deformations, stitching errors, other)
through study completion, an average of 2 hours

Collaborators and Investigators

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

Sponsor

University Hospital Heidelberg

Investigators

  • Principal Investigator: Wolfgang Bömicke, Prof. Dr., Department of Prosthetic Dentistry, University of Heidelberg

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)

July 1, 2022

Primary Completion (Actual)

January 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

August 10, 2021

First Submitted That Met QC Criteria

August 26, 2021

First Posted (Actual)

September 2, 2021

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZI²

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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