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.
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.
Belgium1 site, 1 recruiting
- Recruiting
Institut de Dentisterie
Liège, Liege, 4000
Nathalie Robert, DDS, +32496318211, n.robert@chuliege.be
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.
- Conditions
- Dental Implant Failed
- 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 group | Role | What they receive |
|---|---|---|
| Patients with 4-8 osseointegrated implants | Other | On 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.
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)
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.
- First posted26 Aug 2024
- Study start18 Jun 2024
- Primary completionOct 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant FailedStudies of the same condition, open and under way.
- 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
- 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)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathalie Robert, Centre Hospitalier Universitaire de Liege
- Investigators
- Marc Pr Lamy, Phd, Study director, Centre Hospitalier Universitaire de Liege
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06570499
- Acronym / sponsor ID
- B7072024000032
- Conditions
- Dental Implant Failed
- Keywords
- accuracy, photogrammetry, dental implant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de LiegeUniversity, hospital or other
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 26 Aug 2024 (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.
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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a group of patients: 6 different impressions taken from the same patient. Analysis of the impressions in a second step
| Arm | Type | Receives |
|---|---|---|
| Patients with 4-8 osseointegrated implants | Other | Other: Implant impressionOn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- edentulous maxilla or mandible with 4 to 8 osseointegrated implants (NobelBiocare®) and transgingival abutments tightened to 35N/cm (Multi-unit, NobelBiocare®).
Key exclusion criteria (3 listed)
- Patients with non-osseointegrated implants
- Patients with different implant systems
- Patients with incomplete edentulism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implant impressiondefinitive impressions on implants | Other | Patients with 4-8 osseointegrated implants |
Primary outcome
Compare the precision of a complete-arch impression
Time frame: The impressions will be taken on the same day, the appointment lasts one hour.
6 impressions are taken on one patient
1 secondary outcome
Obtain patient satisfaction with these new types of impression.
Time frame: The questionnaire is handed out after the impressions, during the only appointment of this study (one hour).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Marc Pr Lamy, Phd study director
Centre Hospitalier Universitaire de Liege
1 site in 1 country: see every site and its status.
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.