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Dental Implant FailedNCT06570499

Comparison of Conventional Impressions, Intraoral Scanners and Digital Photogrammetry for Full-arch Implant Prosthesis.

A study testing Implant impression in people with Dental Implant Failed, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this clinical trial is to compare implant-supported definitive impressions in edentulous patients (mandible or maxilla) with 4 to 8 osseointegrated implants. The main questions it aims to answer are : The primary outcome of this prospective clinical comparative study is to analyse the precision of a… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dental Implant Failed
What is being tested?
Implant impression
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteBelgium
Study dates
18 Jun 2024to 15 Dec 2024
Phase
Interventional
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • edentulous maxilla or mandible with 4 to 8 osseointegrated implants (NobelBiocare®) and transgingival abutments tightened to 35N/cm (Multi-unit, NobelBiocare®).

Who cannot join

  • Patients with non-osseointegrated implants
  • Patients with different implant systems
  • Patients with incomplete edentulism

Trial locations and contacts

1 site in 1 country.

Nathalie Robert, DDS contact

+32496318211

n.robert@chuliege.be

Belgium1 site, 1 recruiting
  • Institut de Dentisterie

    Liège, Liege, 4000

    Nathalie Robert, DDS, +32496318211, n.robert@chuliege.be

    Recruiting

Other trials in Belgium

About this study

Official title: Precision, Patient Satisfaction and Timing of Complete-arch Digital Implant Impression With a Conventional Impression, an Intraoral Scanner and a Photogrammetry Technique: A Prospective Clinical Comparative Study

The aim of this clinical trial is to compare implant-supported definitive impressions in edentulous patients (mandible or maxilla) with 4 to 8 osseointegrated implants. The main questions it aims to answer are :

The primary outcome of this prospective clinical comparative study is to analyse the precision of a complete-arch impression.

The secondary aim is to obtain patient satisfaction with these new types of impression.

The different impressions (conventional, intraoral scanner and photogrammetry) will be taken twice on the same patient.

Read the detailed description

For each patient, 6 impressions were taken in the same order: 2 IOS, 2 photogrammetry, 2 conventional impressions. A satisfaction questionnaire in the form of a Visual Analogue Scale (VAS) was given after each group of impressions. The time required for each impression was also measured

Clinical and laboratory Protocol The conventional impression will taken in plaster using an open tray technique (Dr. Balzer® Special plaster, Siladent). The impression copings (Impression Coping Open Tray Multi-unit, NobelBiocare) will be screwed onto the transgingival abutments. The plaster wil then prepared with the 50:100 water/powder ratio recommended by the manufacturer. The resulting impression will then cast with low-extension plaster and digitized using a high-precision laboratory scanner. The entire procedure wil be conducted twice.

The IOS impression will obtained using an intraoral scanner (TRIOS4; 3Shape A/S) with implant scan bodies screwed at the multiunit abutment level (Elos Accurate Multi-Unit; Elos Medtech). The IOS device will be a wireless, powder-free scanner with a pen grip, based on confocal microscopy laser technology, and operated with software version 1.4.7.5, calibrated immediately before the impression. The scanning strategy will be consistent for all procedures, consisting of a first scan of the gingiva and implants, in accordance with the manufacturer's recommendations. The scanbodies will be then hand screwed and a second scan will be performed using the following scan path: from the last distal implant in a zigzag pattern[26]. The entire procedure will be conducted twice.

Photogrammetry will be carried out using an Imetric camera (ICam4D; Imetric4D Imaging Sàrl). The first step will be to use an intraoral scanner to scan the gingiva and optical markers screwed onto the transgingival abutments. In a second step, the scan bodies with superficial target points and titanium interfaces (ICamBody; Imetric4D Imaging Sàrl) will be hand screwed to the transgingival components. The ICamBodies will be placed with a visible edge in accordance with the manufacturer's recommendations. The operator will set up the photogrammetric camera (ICam4D; Imetric4D Imaging Sàrl) and directly capture the scan bodies from right to left at 10 cm to 15 cm from the lips. At least 2 sides of the scan body, with 3 target points on each side, will be captured according to the manufacturer's instructions. The scanbodies will be unscrewed and screwed back in random order and a second recording will be made after recalibrating the photogrammetry. The coordinates from the photogrammetry will be exported the to dedicated software to be merged with the STL file form the intraoral scanner. The entire procedure will be conducted twice.

Patient-reported outcome measures (PROMs) PROMs will be obtained using a Visual Analog Scale (VAS, [27]) immediately after the impression. For each impression technique, six domains will be used to evaluate which of the two was less unpleasant: (a) opinion on treatment length (1 = unsatisfactory to 10 = excellent), (b) comfort level during impression procedures (1 = unsatisfactory to 10 = excellent), (c) anxiety level before impression procedures (1 = high to 10 = low), (d) unpleasant taste during/after impression procedures (1 = bad taste to 10 = none), (e) nausea during the impression procedure (1 = severe to 10 = none), and (f) pain during impression procedures (1 = painful to 10 = none). For all Visual Analog Scales (VAS), higher scores indicated greater satisfaction with the procedure.

Being tested
Implant impression
Keywords
accuracy, photogrammetry, dental implant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implant impressionOther

    definitive impressions on implants

Study groups in NCT06570499
Study groupRoleWhat they receive
Patients with 4-8 osseointegrated implantsOtherOn the patient, we will successively take 6 impressions (2 conventional, 2 intraoral scanner, 2 photogrammetry) and then analyze these impressions to measure the repeatability of a technique. After each type of impression, a satisfaction questionnaire in VAS format will be given to the patient.
Receives: Other: Implant impression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare the precision of a complete-arch impression

    6 impressions are taken on one patient

    Measured: The impressions will be taken on the same day, the appointment lasts one hour.

Secondary outcomes (1)
  1. Obtain patient satisfaction with these new types of impression.

    Patients complete a satisfaction questionnaire in VAS format

    Measured: The questionnaire is handed out after the impressions, during the only appointment of this study (one hour).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2024
  2. Study start18 Jun 2024
  3. Primary completionOct 2024 (estimated)
  4. Study completion15 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Model description
a group of patients: 6 different impressions taken from the same patient. Analysis of the impressions in a second step
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06570499
Sponsor's protocol ID
B7072024000032
Status last verified
Aug 2024
First submitted
23 Aug 2024
Last updated
26 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Implant impression in people with Dental Implant Failed, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.

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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Aug 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 Belgium. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nathalie Robert, DDS (+32496318211, n.robert@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare the precision of a complete-arch impression (time frame: The impressions will be taken on the same day, the appointment lasts one hour.). 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 26 Aug 2024.

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