Intraoral Scanning Accuracy in the Edentulous Mandible

NCT05032170 | Completed

• 1 other identifier: ZI²
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Jaw, Edentulous; Dental Impression Techniques

Keywords

intraoral scan; scanning accuracy; edentulousness; implant scan; digital impression

Outcome Measures

Primary Outcomes (1)

• Effect of intraoral scanner on scanning accuracy

  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 Outcomes (3)

• Effect of artificial landmarks on scanning accuracy

  through study completion, an average of 2 hours

• Effect of implant attachment on scanning accuracy in [µm] and [°]

  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)

  through study completion, an average of 2 hours

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 \[Kappel S, Giannakopoulos NN, Eberhard L, Rammelsberg P, Eiffler C. Immediate Loading of Dental Implants in Edentulous Mandibles by Use of Locator® Attachments or Dolder® Bars: Two-Year Results from a Prospective Randomized Clinical Study. Clin Implant Dent Relat Res. 2016 Aug;18(4):752-61. doi: 10.1111/cid.12349. Epub 2015 May 7. PMID: 25950679.\].

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

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

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Officials

• Wolfgang Bömicke, Prof. Dr.

  Department of Prosthetic Dentistry, University of Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: September 2, 2021
• Study Start: July 1, 2022
• Primary Completion: January 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

DE (1)