Digitalization AccuracyNCT06423482
Accuracy and Scannability of Implant-Supported Framework Materials
A study testing PEEK bar and Titanium bar in people with Digitalization Accuracy, run by Nourhan Samy at 1 site in Egypt.
Trial summary
The present study aims to clinically evaluate and compare the scanning accuracy and the scannability of 2 different materials used in constructing frameworks for implant-supported prosthesis (titanium and PEEK). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Digitalization Accuracy
- What is being tested?
- PEEK bar and Titanium bar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 14 May 2024to 14 Nov 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Maxillary edentulous adult patient with a good health status classified as ASA I or II physical status and having maxillary osseointegrated dental implants.
- Adequate maxillary restorative space (6-8 mm).
- Adequate zone of keratinized tissue (at least 2 mm).
- Presence of an antagonistic dentate or rehabilitated arch.
Who cannot join
- A systemic disease that compromises osseointegration such as uncontrolled diabetes mellitus or metabolic bone diseases.
- Improper implant position.
- Heavy smoking.
- Inability to obtain written informed consent.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digitization Accuracy and Scannability of Two Different Implant-Supported Prosthodontic Framework Materials
The present study aims to clinically evaluate and compare the scanning accuracy and the scannability of 2 different materials used in constructing frameworks for implant-supported prosthesis (titanium and PEEK).
The objective of the present study is to evaluate the digitization accuracy and scannability of milled titanium and PEEK implant-supported frameworks in intra-oral conditions and to evaluate the accuracy of the superstructures designed and constructed over the intraorally scanned framework.
Read the detailed description
Background: For implementing a fully digital workflow, intraoral scanning of prosthetic frameworks may be required for editing purposes in some clinical scenarios. Different materials can be used in constructing implant-supported prosthetic frameworks. However, the scannability and the influence of the material used on the accuracy of the intraoral scan are still unclear.
Aim of the study: The purpose of this in vivo study is to evaluate the scanning accuracy and the scannability of different framework materials and to assess the marginal adaptation and accuracy of the superstructures designed and constructed over different scanned framework materials.
Materials and methods: Two milled maxillary implant-supported frameworks constructed from 2 different materials will be used in this study. Group I will be constructed from titanium and group II from Poly-Ether-Ether-Ketone (PEEK). The frameworks will be digitized by using a desktop scanner (Tabletop Scanner, Medit T-310; Medit Corp). The STL file produced will be considered as a reference file. Each framework will be scanned intraorally (n=10) by using an intraoral scanner (IOS) (Medit i700; Medit Corp). The STL files obtained from the intraoral scanner will be compared to the reference STL file to assess the scannability. The unscanned surface area in a preset time limit will be used to determine the scannability of each framework. To evaluate the scanning accuracy, all STL files will be imported into a surface-matching software program (Medit Design v3.0.6 Build 286; Medit Corp) where deviation measurements in (μm) will be calculated. A total of 20 superstructures made of nano-ceramic hybrid resin (Flexcera™ Smile Ultra) will be 3D-printed from each STL file obtained from intraoral scanning of the frameworks and then the marginal adaptation will be evaluated by using a stereomicroscope (SZ1145TR; Olympus, Japan). The accuracy will also be assessed by using a surface-matching software program (Geomagic Control X v.2018.1.1; 3D Systems).
Analysis: Data will be collected, tabulated, and statistically analyzed by using the appropriate statistical tests.
Keywords: Digitization, accuracy, trueness, precision, scannability, implant-supported frameworks, superstructures, marginal adaptation, titanium, PEEK, digital workflow, editing, nano-ceramic hybrid resin.
- Conditions
- Digitalization Accuracy
- Being tested
- PEEK bar, Titanium bar
- Keywords
- Digitization, Accuracy, Trueness, Precision, Scannability, Implant-supported frameworks, Superstructures, Marginal adaptation, Titanium, PEEK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEK barOther
The framework will be constructed from Poly-Ether-Ether-Ketone (PEEK). The framework will be digitized by using a desktop scanner (Tabletop Scanner, Medit T-310; Medit Corp). The STL file produced will be considered as a reference file. Each framework will be scanned intraorally (n=10) by using an intraoral scanner (IOS) (Medit i700; Medit Corp).
Titanium barOther
The framework will be constructed from titanium. The framework will be digitized by using a desktop scanner (Tabletop Scanner, Medit T-310; Medit Corp). The STL file produced will be considered as a reference file. Each framework will be scanned intraorally (n=10) by using an intraoral scanner (IOS) (Medit i700; Medit Corp).
| Study group | Role | What they receive |
|---|---|---|
| PEEK bar | Experimental | Not described Receives: Other: PEEK bar |
| Titanium bar | Experimental | Not described Receives: Other: Titanium bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digitization accuracy of the two different framework materials.
All scans obtained will be cropped eliminating soft tissue areas guided by the bar's finish line.
The STL(D) file obtained from scanning the frameworks by using the desktop scanner will be used as reference scan for the assessment of trueness in the study, to measure the discrepancy with the corresponding 10 STLI files in each group.
In each reference STL(D) file, the framework will be selected and used for alignment with their corresponding STL(I) with the best fit alignment algorithm to assess trueness, and then all the STL(I) in each material group will be superimposed to assess precision by using a specialized software program (Medit link). For the quantitative evaluation of 3D deviations between the reference STL(D) and the target data STL(I), the software program deviation display mode will be used to produce color-difference maps from which RMS (root mean square) will be calculated for statistical analysis.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start14 May 2024
- Primary completion14 Nov 2024
- Study completion14 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Digitalization AccuracyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan Samy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nourhan Samy, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423482
- Sponsor's protocol ID
- 0796-11/2023
- Status last verified
- Jan 2025
- First submitted
- 16 May 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Emam NS, Metwally NA, Khamis MM. Influence of substructure material on the scanning accuracy and scannability of implant-supported full arch bar substructures. Sci Rep. 2025 Dec 3;15(1):43110. doi: 10.1038/s41598-025-28419-2.
PubMed 41339678
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digitization Accuracy and Scannability of Two Different Implant-Supported Prosthodontic Framework Materials
- ClinicalTrials.gov ID
- NCT06423482
- Acronym / sponsor ID
- 0796-11/2023
- Conditions
- Digitalization Accuracy
- Keywords
- Digitization, Accuracy, Trueness, Precision, Scannability, Implant-supported frameworks, Superstructures, Marginal adaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Nourhan SamyUniversity, hospital or other
- Study start
- 14 May 2024 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 14 Nov 2024 (actual)
- First posted
- 21 May 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 present study aims to clinically evaluate and compare the scanning accuracy and the scannability of 2 different materials used in constructing frameworks for implant-supported prosthesis (titanium and PEEK).
The objective of the present study is to evaluate the digitization accuracy and scannability of milled titanium and PEEK implant-supported frameworks in intra-oral conditions and to evaluate the accuracy of the superstructures designed and constructed over the intraorally scanned framework.
Detailed description
Background: For implementing a fully digital workflow, intraoral scanning of prosthetic frameworks may be required for editing purposes in some clinical scenarios. Different materials can be used in constructing implant-supported prosthetic frameworks. However, the scannability and the influence of the material used on the accuracy of the intraoral scan are still unclear.
Aim of the study: The purpose of this in vivo study is to evaluate the scanning accuracy and the scannability of different framework materials and to assess the marginal adaptation and accuracy of the superstructures designed and constructed over different scanned framework materials.
Materials and methods: Two milled maxillary implant-supported frameworks constructed from 2 different materials will be used in this study. Group I will be constructed from titanium and group II from Poly-Ether-Ether-Ketone (PEEK). The frameworks will be digitized by using a desktop scanner (Tabletop Scanner, Medit T-310; Medit Corp). The STL file produced will be considered as a reference file. Each framework will be scanned intraorally (n=10) by using an intraoral scanner (IOS) (Medit i700; Medit Corp). The STL files obtained from the intraoral scanner will be compared to the reference STL file to assess the scannability. The unscanned surface area in a preset time limit will be used to determine the scannability of each framework. To evaluate the scanning accuracy, all STL files will be imported into a surface-matching software program (Medit Design v3.0.6 Build 286; Medit Corp) where deviation measurements in (μm) will be calculated. A total of 20 superstructures made of nano-ceramic hybrid resin (Flexcera™ Smile Ultra) will be 3D-printed from each STL file obtained from intraoral scanning of the frameworks and then the marginal adaptation will be evaluated by using a stereomicroscope (SZ1145TR; Olympus, Japan). The accuracy will also be assessed by using a surface-matching software program (Geomagic Control X v.2018.1.1; 3D Systems).
Analysis: Data will be collected, tabulated, and statistically analyzed by using the appropriate statistical tests.
Keywords: Digitization, accuracy, trueness, precision, scannability, implant-supported frameworks, superstructures, marginal adaptation, titanium, PEEK, digital workflow, editing, nano-ceramic hybrid resin.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEEK bar | Experimental | Other: PEEK bar |
| Titanium bar | Experimental | Other: Titanium bar |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Maxillary edentulous adult patient with a good health status classified as ASA I or II physical status and having maxillary osseointegrated dental implants.
- Adequate maxillary restorative space (6-8 mm).
- Adequate zone of keratinized tissue (at least 2 mm).
- Presence of an antagonistic dentate or rehabilitated arch.
Key exclusion criteria (5 listed)
- A systemic disease that compromises osseointegration such as uncontrolled diabetes mellitus or metabolic bone diseases.
- Improper implant position.
- Heavy smoking.
- Inability to obtain written informed consent.
- -
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 |
|---|---|---|
| PEEK barThe framework will be constructed from Poly-Ether-Ether-Ketone (PEEK). The framework will be digitized by using a desktop scanner (Tabletop Scanner, Medit T-310; Medit Corp). The STL file produced will be considered as a reference file. Each framework will be scanned intraorally (n=10) by using an intraoral scanner (IOS) (Medit i700; Medit Corp). | Other | PEEK bar |
| Titanium barThe framework will be constructed from titanium. The framework will be digitized by using a desktop scanner (Tabletop Scanner, Medit T-310; Medit Corp). The STL file produced will be considered as a reference file. Each framework will be scanned intraorally (n=10) by using an intraoral scanner (IOS) (Medit i700; Medit Corp). | Other | Titanium bar |
Primary outcome
Digitization accuracy of the two different framework materials.
Time frame: one year
All scans obtained will be cropped eliminating soft tissue areas guided by the bar's finish line. The STL(D) file obtained from scanning the frameworks by using the desktop scanner will be used as reference scan for the assessment of trueness in the study, to measure the discrepancy with the corresponding 10 STLI files in each group. In each reference STL(D) file, the framework will be selected and used for alignment with their corresponding STL(I) with the best fit alignment algorithm to assess trueness, and then all the STL(I) in each material group will be superimposed to assess precision by using a specialized software program (Medit link). For the quantitative evaluation of 3D deviations between the reference STL(D) and the target data STL(I), the software program deviation display mode will be used to produce color-difference maps from which RMS (root mean square) will be calculated for statistical analysis.
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 29 Jan 2025.
- Derived from this study: PubMed 41339678Emam NS, Metwally NA, Khamis MM. Influence of substructure material on the scanning accuracy and scannability of implant-supported full arch bar substructures. Sci Rep. 2025 Dec 3;15(1):43110. doi: 10.1038/s41598-025-28419-2.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEK bar and Titanium bar in people with Digitalization Accuracy, run by Nourhan Samy 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 4 inclusion and 5 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 29 Jan 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?
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?
Digitization accuracy of the two different framework materials. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06423482, which also lists 1 linked publication.
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 29 Jan 2025.