Skip to main content
OpenTrials
Completed

NCT Number: NCT05032170

Intraoral Scanning Accuracy 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Jaw, Edentulous Dental Impression Techniques Jaw Diseases Mouth Diseases Mouth, Edentulous Musculoskeletal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Prosthetic Dentistry, University Hospital Heidelberg, University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Who can participate

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

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

Treatment and study plan

Primary outcomes

  1. 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 [°].

Secondary outcomes

  1. 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 [°].

  2. 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 [°].

  3. 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)

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 2, 2021
Registry last updated
May 8, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.