Jaw, EdentulousNCT05032170
Intraoral Scanning Accuracy in the Edentulous Mandible
An observational study of Jaw, Edentulous and Dental Impression Techniques, run by University Hospital Heidelberg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Jaw, Edentulous, Dental Impression Techniques
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
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.].
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Prosthetic Dentistry, University Hospital Heidelberg, University of Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
About this study
Official title: 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.
- Conditions
- Jaw, Edentulous, Dental Impression Techniques
- Keywords
- intraoral scan, scanning accuracy, edentulousness, implant scan, digital impression
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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 [°].
Measured: through study completion, an average of 2 hours
Secondary outcomes (3)
Effect of artificial landmarks 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 [°].
Measured: through study completion, an average of 2 hours
Effect of implant attachment on scanning accuracy in [µm] and [°]
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 [°].
Measured: 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)
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)
Measured: through study completion, an average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Jul 2022
- Primary completion31 Jan 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaw, EdentulousStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Wolfgang Bömicke, University Hospital Heidelberg
- Investigators
- Wolfgang Bömicke, Prof. Dr., Principal investigator, Department of Prosthetic Dentistry, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032170
- Sponsor's protocol ID
- ZI²
- Status last verified
- May 2024
- First submitted
- 10 Aug 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Accuracy of Two Intraoral Scanning Systems in Detecting Two Inter-foraminal Implants in the Edentulous Mandible.
- ClinicalTrials.gov ID
- NCT05032170
- Acronym / sponsor ID
- ZI²
- Conditions
- Jaw, Edentulous, Dental Impression Techniques
- Keywords
- intraoral scan, scanning accuracy, edentulousness, implant scan, digital impression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.].
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 [°].
3 secondary outcomes
Effect of artificial landmarks on scanning accuracy
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Bömicke, Prof. Dr. principal investigator
Department of Prosthetic Dentistry, University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Jaw, Edentulous and Dental Impression Techniques, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of intraoral scanner on scanning accuracy (time frame: through study completion, an average of 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.