Digital TechnologyNCT06177782
Accuracy of Tooth Modified Scan Bodies as a Novel Technique
A study testing Tooth modified scan bodies and Conventional scan bodies in people with Digital Technology and Dental, run by Ain Shams University at 1 site in Egypt.
Trial summary
The clinical performance of a novel scan body Tooth Modified Scan Body (TMSB) in the degree of trueness of IOS impression for full arch cases. I Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Digital Technology, Dental
- What is being tested?
- Tooth modified scan bodies and Conventional scan bodies
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2023to 20 Nov 2023
- 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants who had received 4-6 implants in 1 edentulous arch.
- Participants with 1-piece implant-supported complete-arch fixed dental prostheses.
- Systemically free.
- Primary implant stability exceed 72 the day of the definitive impression.
Who cannot join
- Smoker's.
- Non co-operative patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Tooth Modified Scan Bodies as a Novel Technique for Edentulous Full Arch Implant Supported Dental Prosthesis: A Controlled Clinical Trial
The clinical performance of a novel scan body Tooth Modified Scan Body (TMSB) in the degree of trueness of IOS impression for full arch cases.
I
Read the detailed description
The clinical performance of a novel scan body Tooth Modified Scan Body (TMSB) in the degree of trueness of IOS impression for full arch cases. TMSB is a scan body to which different teeth are attached directly as one piece, this may enhance the accuracy level by filling the gabs between ISB as well as acting as a stable artificial AI-easily recognized landmarks thus facilitating the scanning procedure. OS impression utilizing tooth modified scan bodies or conventional scan bodies result in the same degree of trueness as conventional verified splinted open tray impression. To our knowledge, it is the first time in the literature to utilize a novel scan body modified with directly connected teeth as artificial landmarks in vivo.
- Conditions
- Digital Technology, Dental
- Being tested
- Tooth modified scan bodies, Conventional scan bodies
- Keywords
- Jaw relation, Scan body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth modified scan bodiesDevice
Tooth modified scan bodies are used during scanning for full arch implant cases.
Conventional scan bodiesDevice
Conventional scan bodies will be used for scanning the full arch implant cases.
| Study group | Role | What they receive |
|---|---|---|
| Tooth Modified Scan Bodies | Active comparator | The intraoral scanner (IOS) impression will be recorded using modified scan bodies. The IOS device will be calibrated right before the impression. The scan strategy will be consistent for all the procedures following the manufacturer guidelines. Receives: Device: Tooth modified scan bodies |
| Conventional Scan Bodies | Placebo comparator | The intraoral scanner (IOS) impression will be recorded using conventional implant scan bodies secured at the multiunit abutment level. Receives: Device: Conventional scan bodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of trueness
Digital files will be obtained: either conventional scan or TMSB scan. All the STL files will be imported to dental CAD software , and scan bodies will be converted to implant multi-unit ti-base replicas using a digital library. Then, updated STL files will be imported to inspection software for trueness assessments.
Measured: Immediately postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start10 Jan 2023
- Primary completion18 Oct 2023
- Study completion20 Nov 2023
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 Digital TechnologyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- 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
- NCT06177782
- Sponsor's protocol ID
- 22859
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Eldabe AK, Adel-Khattab D, Botros KH. Trueness of tooth modified scan bodies as a novel technique for edentulous full arch implant supported dental prosthesis: an in vivo prospective comparative study. BMC Oral Health. 2025 Jan 6;25(1):29. doi: 10.1186/s12903-024-05172-y.
PubMed 39762850
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Tooth Modified Scan Bodies as a Novel Technique for Edentulous Full Arch Implant Supported Dental Prosthesis: A Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06177782
- Acronym / sponsor ID
- 22859
- Conditions
- Digital Technology, Dental
- Keywords
- Jaw relation, Scan body
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 20 Dec 2023 (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 clinical performance of a novel scan body Tooth Modified Scan Body (TMSB) in the degree of trueness of IOS impression for full arch cases.
I
Detailed description
The clinical performance of a novel scan body Tooth Modified Scan Body (TMSB) in the degree of trueness of IOS impression for full arch cases. TMSB is a scan body to which different teeth are attached directly as one piece, this may enhance the accuracy level by filling the gabs between ISB as well as acting as a stable artificial AI-easily recognized landmarks thus facilitating the scanning procedure. OS impression utilizing tooth modified scan bodies or conventional scan bodies result in the same degree of trueness as conventional verified splinted open tray impression. To our knowledge, it is the first time in the literature to utilize a novel scan body modified with directly connected teeth as artificial landmarks in vivo.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tooth Modified Scan Bodies | Active comparator | Device: Tooth modified scan bodiesThe intraoral scanner (IOS) impression will be recorded using modified scan bodies. The IOS device will be calibrated right before the impression. The scan strategy will be consistent for all the procedures following the manufacturer guidelines. |
| Conventional Scan Bodies | Placebo comparator | Device: Conventional scan bodiesThe intraoral scanner (IOS) impression will be recorded using conventional implant scan bodies secured at the multiunit abutment level. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants who had received 4-6 implants in 1 edentulous arch.
- Participants with 1-piece implant-supported complete-arch fixed dental prostheses.
- Systemically free.
- Primary implant stability exceed 72 the day of the definitive impression.
Key exclusion criteria (2 listed)
- Smoker's.
- Non co-operative 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 |
|---|---|---|
| Tooth modified scan bodiesTooth modified scan bodies are used during scanning for full arch implant cases. | Device | Tooth Modified Scan Bodies |
| Conventional scan bodiesConventional scan bodies will be used for scanning the full arch implant cases. | Device | Conventional Scan Bodies |
Primary outcome
Degree of trueness
Time frame: Immediately postoperative
Digital files will be obtained: either conventional scan or TMSB scan. All the STL files will be imported to dental CAD software , and scan bodies will be converted to implant multi-unit ti-base replicas using a digital library. Then, updated STL files will be imported to inspection software for trueness assessments.
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 20 Dec 2023.
- Derived from this study: PubMed 39762850Eldabe AK, Adel-Khattab D, Botros KH. Trueness of tooth modified scan bodies as a novel technique for edentulous full arch implant supported dental prosthesis: an in vivo prospective comparative study. BMC Oral Health. 2025 Jan 6;25(1):29. doi: 10.1186/s12903-024-05172-y.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tooth modified scan bodies and Conventional scan bodies in people with Digital Technology and Dental, run by Ain Shams University 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 2 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 20 Dec 2023. 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. Some participants in this study may receive a placebo. 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?
Degree of trueness (time frame: Immediately postoperative). 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 NCT06177782, 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 20 Dec 2023.