Edentulous MaxillaNCT06669065
Comparing Scanning Accuracy of Full-Arch Maxillary Implants: Extraoral vs. Intraoral Techniques
A study testing extraoral versus intraoral scanning techniques in people with Edentulous Maxilla, run by Misr University for Science and Technology at 1 site in Egypt.
Trial summary
Data acquisition from the patients: After 4 months of implant placement, three impressions/scans will be made for each patient as follows: Data 1: conventional impression using open tray transfer copings and silicon impression material. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Edentulous Maxilla
- What is being tested?
- extraoral versus intraoral scanning techniques
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jun 2024to 25 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Completely edentulous patients who had been wearing complete dentures and received 4 implants in the upper jaw.
- Patients with no systemic diseases affecting bone remodelling and osseointegration.
- Ridges showing well-keratinized mucosa.
Who cannot join
- Smokers.
- Non-compliant patients.
- Patients with systemic diseases that may affect bone remodelling and osseointegration.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Misr University for Science and Technology
Giza, Giza Governorate, 12573
About this study
Official title: Assessment Of Scanning Accuracy of Maxillary Full-Arch Dental Implants Using Extraoral Vs Intraoral Scanning Techniques. [A Clinical Study]
Data acquisition from the patients:
After 4 months of implant placement, three impressions/scans will be made for each patient as follows:
Read more
Data 1: conventional impression using open tray transfer copings and silicon impression material. After cast verification, the scan bodies will be connected to the analogues on the master cast, which will be scanned using a laboratory scanner. The STL file will be used as a reference scan.
Data 2: The scan bodies will be connected to the implants intraorally, and an intraoral scan will be made using the intraoral scanner. The STL file will be stored for comparison.
Data 3: the scan bodies will be splinted using dental floss after being connected to the implants intraorally and then a scan will be made using the intraoral scanner. The STL file will be stored for comparison.
- Data alignment and accuracy measurements: The accuracy measurement will be done based on ISO 5725 in which a combination of trueness and precision was approved to define the accuracy of the measurement method. (15) The scanned data will be compared as follows: the STL files from the intraoral digital scans (data 2 and 3) and the extraoral scan of the master cast (data 1) will be imported into a 3D inspection software program that is a metrology program used to analyse and compare 3D meshes. The information for both reference and targets (the scanned data to be compared) will be uploaded into the program and the area of interest of 3D meshes will be marked, The "3D Compare" function will be employed by projecting all paired points with a colour-coded map created to display the deviation patterns of the investigated surfaces. The superimpositions will be used to assess the 3D accuracy for both the digital intraoral scans with the extraoral scan of the verified stone casts.
- Statistical analysis: Data will be collected, analysed, and then tabulated.
Read the detailed description
Data acquisition from the patients:
After the osseointegration period of the dental implants, three impressions/scans will be made for each patient as follows:
- Data #1: A conventional impression using open tray transfer copings will be connected to the dental implants intraorally and splinted together using dental floss and a duralay resin pattern to ensure complete fixation and immobility. Then, a custom acrylic resin tray with an open window and silicon impression material will be used for the final impression making. a master cast will be poured, and the transfer copings will be reconnected onto the implant analogues inside the cast to replicate implant positions intraorally. the transfer copings/impression posts will be connected with duralay resin pattern to form a verification jig assembly. The verification jig assembly will be connected to the implants inside the patient's mouth to check passivity, in case of improper passivity, the jig will be sectioned at areas between the implants and then reconnected with duraly and an impression will be repeated, if passivity is ensured, the verification jig assembly will be reconnected to the master cast that will be then deemed as a verified master cast. The next step after master cast verification is the connection of the scan bodies to the implant analogues then scanning it with a laboratory scanner to gain an STL file of the (control) group or the (reference) group of the research.
- Data #2: The scan bodies will be connected to the implants intraorally, and an intraoral scan will be made using the intraoral scanner. The STL file will be stored for comparison. (comparator 1)
- Data #3: scan bodies will be splinted together using dental floss and composite resin will be added to the floss at areas found between the scan bodies to add some irregularities, then a scan will be made using the intraoral scanner. The STL file will be stored for comparison. (comparator 2)
- Data alignment and accuracy measurements:
The accuracy measurement will be done based on ISO 5725 in which a combination of trueness and precision was approved to define the accuracy of the measurement method. (15) The scanned data will be compared as follows: the STL files from the intraoral digital scans (data 2 and 3) and the extraoral scan of the master cast (data 1) will be imported into a 3D inspection software program that is a metrology program used to analyse and compare 3D meshes. The information for both reference and targets (the scanned data to be compared) will be uploaded into the program and the area of interest of 3D meshes will be marked, The "3D Compare" function will be employed by projecting all paired points with a colour-coded map created to display the deviation patterns of the investigated surfaces. The superimpositions will be used to assess the 3D accuracy for both the digital intraoral scans with the extraoral scan of the verified stone casts.
- Statistical analysis:
- Handling of numerical/quantitative variables:
Numerical data will be explored for normality by checking the data distribution using Kolmogorov- Smirnov and Shapiro-Wilk tests. Data will be presented as mean \& standard deviation. If data will be normally distributed comparison between 2 different groups will be performed by using Independent t-test, a comparison between 2 related groups will be performed by using a Paired t-test, while a comparison between more than 2 groups will be performed by using A Way ANOVA test followed by Tukey's Post Hoc test for multiple comparisons.
If data will be non-parametric data comparison between 2 different groups will be performed by using the Mann-Whitney test, a comparison between 2 related groups will be performed by using the Wilcoxon Signed Rank test, while a comparison between more than 2 groups will be performed by using Kruskal-Wallis test.
- Handling of categorial/qualitative variables: Data will be presented as frequency and percentages. All comparisons will be performed by using the Chi-square test.
Statistical analysis:
Data will be collected, tabulated, and statistically analyzed using Microsoft Excel ® 2016, Statistical Package for Social Science (SPSS)® Ver. 24. and Minitab ® statistical software Ver. 16.
- Conditions
- Edentulous Maxilla
- Being tested
- extraoral versus intraoral scanning techniques
- Keywords
- scanning of all on x maxillary dental implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extraoral versus intraoral scanning techniquesDevice
different data acquisition techniques for full-arch dental implants
| Study group | Role | What they receive |
|---|---|---|
| patients rehabilitated with dental implants in upper edentulous jaws | Experimental | patients rehabilitated with dental implants in upper edentulous jaws, then different data acquisition techniques will be applied to the patients using conventional impressions versus intra-oral scanning methods Receives: Device: extraoral versus intraoral scanning techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of accuracy of different intra oral scanning techniques versus the extraoral scanning method
The primary outcome of this study is to evaluate and compare the accuracy of various intraoral scanning techniques against a benchmark established by an extraoral scanning method. Accuracy will be measured using parameters such as dimensional precision, surface detail reproduction, and alignment with reference models. The study aims to determine which intraoral scanning technique provides results that are statistically comparable to or exceed the accuracy of the extraoral method, thereby informing best practices in dental imaging.
Measured: 6 - 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start25 Jun 2024
- Primary completion25 Oct 2024
- Study completion25 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous MaxillaStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HEBA ELSARRIF, Misr University for Science and Technology
- Investigators
- HEBA ELSARRIF, Principal investigator, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669065
- Sponsor's protocol ID
- 2024/0016
- Status last verified
- May 2025
- First submitted
- 24 Oct 2024
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Scanning Accuracy of Maxillary Full-Arch Dental Implants Using Extraoral Vs Intraoral Scanning Techniques. [A Clinical Study]
- ClinicalTrials.gov ID
- NCT06669065
- Acronym / sponsor ID
- 2024/0016
- Conditions
- Edentulous Maxilla
- Keywords
- scanning of all on x maxillary dental implants
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Misr University for Science and TechnologyUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 25 Oct 2024 (actual)
- Study completion
- 25 Dec 2025 (estimated)
- First posted
- 1 Nov 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.
Data acquisition from the patients:
After 4 months of implant placement, three impressions/scans will be made for each patient as follows:
Data 1: conventional impression using open tray transfer copings and silicon impression material. After cast verification, the scan bodies will be connected to the analogues on the master cast, which will be scanned using a laboratory scanner. The STL file will be used as a reference scan.
Data 2: The scan bodies will be connected to the implants intraorally, and an intraoral scan will be made using the intraoral scanner. The STL file will be stored for comparison.
Data 3: the scan bodies will be splinted using dental floss after being connected to the implants intraorally and then a scan will be made using the intraoral scanner. The STL file will be stored for comparison.
- Data alignment and accuracy measurements: The accuracy measurement will be done based on ISO 5725 in which a combination of trueness and precision was approved to define the accuracy of the measurement method. (15) The scanned data will be compared as follows: the STL files from the intraoral digital scans (data 2 and 3) and the extraoral scan of the master cast (data 1) will be imported into a 3D inspection software program that is a metrology program used to analyse and compare 3D meshes. The information for both reference and targets (the scanned data to be compared) will be uploaded into the program and the area of interest of 3D meshes will be marked, The "3D Compare" function will be employed by projecting all paired points with a colour-coded map created to display the deviation patterns of the investigated surfaces. The superimpositions will be used to assess the 3D accuracy for both the digital intraoral scans with the extraoral scan of the verified stone casts.
- Statistical analysis: Data will be collected, analysed, and then tabulated.
Detailed description
Data acquisition from the patients:
After the osseointegration period of the dental implants, three impressions/scans will be made for each patient as follows:
- Data #1: A conventional impression using open tray transfer copings will be connected to the dental implants intraorally and splinted together using dental floss and a duralay resin pattern to ensure complete fixation and immobility. Then, a custom acrylic resin tray with an open window and silicon impression material will be used for the final impression making. a master cast will be poured, and the transfer copings will be reconnected onto the implant analogues inside the cast to replicate implant positions intraorally. the transfer copings/impression posts will be connected with duralay resin pattern to form a verification jig assembly. The verification jig assembly will be connected to the implants inside the patient's mouth to check passivity, in case of improper passivity, the jig will be sectioned at areas between the implants and then reconnected with duraly and an impression will be repeated, if passivity is ensured, the verification jig assembly will be reconnected to the master cast that will be then deemed as a verified master cast. The next step after master cast verification is the connection of the scan bodies to the implant analogues then scanning it with a laboratory scanner to gain an STL file of the (control) group or the (reference) group of the research.
- Data #2: The scan bodies will be connected to the implants intraorally, and an intraoral scan will be made using the intraoral scanner. The STL file will be stored for comparison. (comparator 1)
- Data #3: scan bodies will be splinted together using dental floss and composite resin will be added to the floss at areas found between the scan bodies to add some irregularities, then a scan will be made using the intraoral scanner. The STL file will be stored for comparison. (comparator 2)
- Data alignment and accuracy measurements:
The accuracy measurement will be done based on ISO 5725 in which a combination of trueness and precision was approved to define the accuracy of the measurement method. (15) The scanned data will be compared as follows: the STL files from the intraoral digital scans (data 2 and 3) and the extraoral scan of the master cast (data 1) will be imported into a 3D inspection software program that is a metrology program used to analyse and compare 3D meshes. The information for both reference and targets (the scanned data to be compared) will be uploaded into the program and the area of interest of 3D meshes will be marked, The "3D Compare" function will be employed by projecting all paired points with a colour-coded map created to display the deviation patterns of the investigated surfaces. The superimpositions will be used to assess the 3D accuracy for both the digital intraoral scans with the extraoral scan of the verified stone casts.
- Statistical analysis:
- Handling of numerical/quantitative variables:
Numerical data will be explored for normality by checking the data distribution using Kolmogorov- Smirnov and Shapiro-Wilk tests. Data will be presented as mean \& standard deviation. If data will be normally distributed comparison between 2 different groups will be performed by using Independent t-test, a comparison between 2 related groups will be performed by using a Paired t-test, while a comparison between more than 2 groups will be performed by using A Way ANOVA test followed by Tukey's Post Hoc test for multiple comparisons.
If data will be non-parametric data comparison between 2 different groups will be performed by using the Mann-Whitney test, a comparison between 2 related groups will be performed by using the Wilcoxon Signed Rank test, while a comparison between more than 2 groups will be performed by using Kruskal-Wallis test.
- Handling of categorial/qualitative variables: Data will be presented as frequency and percentages. All comparisons will be performed by using the Chi-square test.
Statistical analysis:
Data will be collected, tabulated, and statistically analyzed using Microsoft Excel ® 2016, Statistical Package for Social Science (SPSS)® Ver. 24. and Minitab ® statistical software Ver. 16.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients rehabilitated with dental implants in upper edentulous jaws | Experimental | Device: extraoral versus intraoral scanning techniquespatients rehabilitated with dental implants in upper edentulous jaws, then different data acquisition techniques will be applied to the patients using conventional impressions versus intra-oral scanning methods |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Completely edentulous patients who had been wearing complete dentures and received 4 implants in the upper jaw.
- Patients with no systemic diseases affecting bone remodelling and osseointegration.
- Ridges showing well-keratinized mucosa.
Key exclusion criteria (3 listed)
- Smokers.
- Non-compliant patients.
- Patients with systemic diseases that may affect bone remodelling and osseointegration.
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 |
|---|---|---|
| extraoral versus intraoral scanning techniquesdifferent data acquisition techniques for full-arch dental implants | Device | patients rehabilitated with dental implants in upper edentulous jaws |
Primary outcome
assessment of accuracy of different intra oral scanning techniques versus the extraoral scanning method
Time frame: 6 - 9 months
The primary outcome of this study is to evaluate and compare the accuracy of various intraoral scanning techniques against a benchmark established by an extraoral scanning method. Accuracy will be measured using parameters such as dimensional precision, surface detail reproduction, and alignment with reference models. The study aims to determine which intraoral scanning technique provides results that are statistically comparable to or exceed the accuracy of the extraoral method, thereby informing best practices in dental imaging.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
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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.
HEBA ELSARRIF principal investigator
Misr University for Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extraoral versus intraoral scanning techniques in people with Edentulous Maxilla, run by Misr University for Science and Technology at 1 site 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 3 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: under way, not looking for participants, as of the sponsor's last update on 8 May 2025. 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 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
assessment of accuracy of different intra oral scanning techniques versus the extraoral scanning method (time frame: 6 - 9 months). 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 2025.