Dental ImplantPhase 1NCT06599294
Accuracy of Intraoral Photogrammetry Scanner in Complete Arch Digital Implant Impression
A Phase 1 study testing Digital scanning and Two digital impressions will be recorded, one with a conventional intra-oral scanner and another one with an intra-oral photogrammetry scanner. in people with Dental Implant, run by Ain Shams University at 2 sites in Egypt.
Trial summary
Intra oral scanning can perform a full digital workflow right on the patient's mouth. Recently an intra-oral photogrammetry scanner has been introduced in the market that can make intra-oral tissue scanning in addition to a built-in photogrammetry technology so that it can capture fixture locations through special… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Dental Implant
- What is being tested?
- Digital scanning and Two digital impressions will be recorded, one with a conventional intra-oral scanner and another one with an intra-oral photogrammetry scanner.
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 20 Jun 2024to 20 Aug 2024
- Phase
- Phase 1
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- participants had received 4-6 implants in 1 edentulous arch.
- Participants had received 1-piece implant-supported complete-arch fixed dental prostheses.
Who cannot join
- Systemic conditions as diabetes.
- Osteoporosis patients.
- Immunocompromised patients.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Dentistry Ain Shams University
Cairo, Abbassia, 11566
Faculty of Dentistry Ain Shams University
Cairo, Abbassia, 15666
About this study
Official title: Accuracy of Intraoral Photogrammetry Scanner (IPS) in Complete Arch Digital Implant Impression: an in Vivo Prospective Comparative Study
Intra oral scanning can perform a full digital workflow right on the patient's mouth. Recently an intra-oral photogrammetry scanner has been introduced in the market that can make intra-oral tissue scanning in addition to a built-in photogrammetry technology so that it can capture fixture locations through special intra-oral scan flags.
Read the detailed description
Intraoral scanning had several advantages to intraoral direct scanning, including less storage and transportation needs, faster scanning times, and increased patient comfort. The intraoral scan bodies are used as digital fixture locators when using IOSs for implant impressions.
Photogrammetry is the science and technology of obtaining reliable information about physical objects through the process of recording, measuring, and interpreting photographic images and patterns of electromagnetic radiant imagery. The utilization of photogrammetry in the dental field leads to exclusion of intraoral dental and gingival anatomies while scanning the implant coordinates. In addition, no need for stitching during full arch implant scanning which is reflected in the trueness and precision of the scanned object. Exclusion of unstable mucosa during scanning and avoidance of stitching make the passive seating of implant prosthesis a more predictable procedure especially when compared with intra-oral scanning only.
Up to this moment, all photogrammetry systems available in the market are considered extraoral systems that require an additional impression for soft tissue capture whether conventional or digital. Recently an intra-oral photogrammetry scanner (IPS) has been introduced in the market that can make intra-oral tissue scanning in addition to a built-in photogrammetry technology so that it can capture fixture locations through special intra-oral scan flags.
- Conditions
- Dental Implant
- Being tested
- Digital scanning, Two digital impressions will be recorded, one with a conventional intra-oral scanner and another one with an intra-oral photogrammetry scanner.
- Keywords
- Digital, photogrammetry, Intra oral scanner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital scanningProcedure or surgery
. For each patient three digital files will be obtained: One reference scan, one conventional IOS scan, and one IPS scan. All the STL files will be imported to dental CAD software, and scan bodies will be converted to implant multi-unit ti-base using a digital library. The updated STL files will be imported to inspection software Mimics for trueness assessments. The three-dimensional discrepancy between 2 STL files will be evaluated in terms of linear and angular deviation. A central point \& central axis of the virtual MUA ti-base was used for deviation measurements. Linear deviations will be assessed for each MUA tibase on the three-space axis (X longitudinal, Y lateral, and Z vertical) using the center of the ti-base heads for the deviation measurement. Angular deviations were assessed as the angles formed by the two lines passing perpendicularly through the centers of the test image and the reference image of each ti-base.
Two digital impressions will be recorded, one with a conventional intra-oral scanner and another one with an intra-oral photogrammetry scanner.Procedure or surgery
. For each patient three digital files will be obtained: One reference scan, one conventional IOS scan, and one IPS scan. All the STL files will be imported to dental CAD software, and scan bodies will be converted to implant multi-unit ti-base using a digital library. The updated STL files will be imported to inspection software Mimics for trueness assessments. The three-dimensional discrepancy between 2 STL files will be evaluated in terms of linear and angular deviation. A central point \& central axis of the virtual MUA ti-base was used for deviation measurements. Linear deviations will be assessed for each MUA tibase on the three-space axis (X longitudinal, Y lateral, and Z vertical) using the center of the ti-base heads for the deviation measurement. Angular deviations were assessed as the angles formed by the two lines passing perpendicularly through the centers of the test image and the reference image of each ti-base.
| Study group | Role | What they receive |
|---|---|---|
| intraoral photogrammetry scanning | Experimental | Not described Receives: Procedure: Digital scanning; Procedure: Two digital impressions will be recorded, one with a conventional intra-oral scanner and another one with an intra-oral photogrammetry scanner. |
| Intra oral scanning | Active comparator | Not described Receives: Procedure: Digital scanning; Procedure: Two digital impressions will be recorded, one with a conventional intra-oral scanner and another one with an intra-oral photogrammetry scanner. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Trueness
The clinical performance of conventional intraoral scanners (IOS) and intraoral photogrammetry scanners (IPS) for each patient enrolled in the study with a paired comparison of the deviation differences
Measured: 4 months following implant insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Jun 2024
- Primary completion10 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Principal investigator, Doaa Adel Salah Khattab, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599294
- Sponsor's protocol ID
- 112899
- Status last verified
- Jul 2024
- First submitted
- 7 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Intraoral Photogrammetry Scanner (IPS) in Complete Arch Digital Implant Impression: an in Vivo Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT06599294
- Acronym / sponsor ID
- 112899
- Conditions
- Dental Implant
- Keywords
- Digital, photogrammetry, Intra oral scanner
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 10 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 19 Sep 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.
Intra oral scanning can perform a full digital workflow right on the patient's mouth. Recently an intra-oral photogrammetry scanner has been introduced in the market that can make intra-oral tissue scanning in addition to a built-in photogrammetry technology so that it can capture fixture locations through special intra-oral scan flags.
Detailed description
Intraoral scanning had several advantages to intraoral direct scanning, including less storage and transportation needs, faster scanning times, and increased patient comfort. The intraoral scan bodies are used as digital fixture locators when using IOSs for implant impressions.
Photogrammetry is the science and technology of obtaining reliable information about physical objects through the process of recording, measuring, and interpreting photographic images and patterns of electromagnetic radiant imagery. The utilization of photogrammetry in the dental field leads to exclusion of intraoral dental and gingival anatomies while scanning the implant coordinates. In addition, no need for stitching during full arch implant scanning which is reflected in the trueness and precision of the scanned object. Exclusion of unstable mucosa during scanning and avoidance of stitching make the passive seating of implant prosthesis a more predictable procedure especially when compared with intra-oral scanning only.
Up to this moment, all photogrammetry systems available in the market are considered extraoral systems that require an additional impression for soft tissue capture whether conventional or digital. Recently an intra-oral photogrammetry scanner (IPS) has been introduced in the market that can make intra-oral tissue scanning in addition to a built-in photogrammetry technology so that it can capture fixture locations through special intra-oral scan flags.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intraoral photogrammetry scanning | Experimental | Procedure: Digital scanning, Procedure: Two digital impressions will be recorded, one with a conventional intra-oral scanner and another one with an intra-oral photogrammetry scanner. |
| Intra oral scanning | Active comparator | Procedure: Digital scanning, Procedure: Two digital impressions will be recorded, one with a conventional intra-oral scanner and another one with an intra-oral photogrammetry scanner. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- participants had received 4-6 implants in 1 edentulous arch.
- Participants had received 1-piece implant-supported complete-arch fixed dental prostheses.
Key exclusion criteria (3 listed)
- Systemic conditions as diabetes.
- Osteoporosis patients.
- Immunocompromised patients.
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 |
|---|---|---|
| Digital scanning. For each patient three digital files will be obtained: One reference scan, one conventional IOS scan, and one IPS scan. All the STL files will be imported to dental CAD software, and scan bodies will be converted to implant multi-unit ti-base using a digital library. The updated STL files will be imported to inspection software Mimics for trueness assessments. The three-dimensional discrepancy between 2 STL files will be evaluated in terms of linear and angular deviation. A central point \& central axis of the virtual MUA ti-base was used for deviation measurements. Linear deviations will be assessed for each MUA tibase on the three-space axis (X longitudinal, Y lateral, and Z vertical) using the center of the ti-base heads for the deviation measurement. Angular deviations were assessed as the angles formed by the two lines passing perpendicularly through the centers of the test image and the reference image of each ti-base. | Procedure or surgery | Intra oral scanning, intraoral photogrammetry scanning |
| Two digital impressions will be recorded, one with a conventional intra-oral scanner and another one with an intra-oral photogrammetry scanner.. For each patient three digital files will be obtained: One reference scan, one conventional IOS scan, and one IPS scan. All the STL files will be imported to dental CAD software, and scan bodies will be converted to implant multi-unit ti-base using a digital library. The updated STL files will be imported to inspection software Mimics for trueness assessments. The three-dimensional discrepancy between 2 STL files will be evaluated in terms of linear and angular deviation. A central point \& central axis of the virtual MUA ti-base was used for deviation measurements. Linear deviations will be assessed for each MUA tibase on the three-space axis (X longitudinal, Y lateral, and Z vertical) using the center of the ti-base heads for the deviation measurement. Angular deviations were assessed as the angles formed by the two lines passing perpendicularly through the centers of the test image and the reference image of each ti-base. | Procedure or surgery | Intra oral scanning, intraoral photogrammetry scanning |
Primary outcome
Degree of Trueness
Time frame: 4 months following implant insertion
The clinical performance of conventional intraoral scanners (IOS) and intraoral photogrammetry scanners (IPS) for each patient enrolled in the study with a paired comparison of the deviation differences
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 19 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Digital scanning and Two digital impressions will be recorded, one with a conventional intra-oral scanner and another one with an intra-oral photogrammetry scanner. in people with Dental Implant, run by Ain Shams University at 2 sites in Egypt.
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 2 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Degree of Trueness (time frame: 4 months following implant insertion). 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 19 Sep 2024.