DentureNCT06281002
Trueness of Full Arch Scans and Generated Digital Implant Models
A study testing conventional impression stone casts digitization, digital scanning with coupled scanning aiding device and Digital Implant Model assessment of accuracy in people with Denture and Complete Edentulism, run by Ain Shams University.
Trial summary
The goal of this clinical trial study is to evaluate the accuracy of the full digital workflow for four-implant, screw-retained mandibular hybrid prostheses in patients with completely edentulous mandible. Read more about this study
- Who is it for?
- Ages 45 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Denture, Complete Edentulism
- What is being tested?
- conventional impression stone casts digitization, digital scanning with coupled scanning aiding device and Digital Implant Model assessment of accuracy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to 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 45 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients having a completely edentulous lower arch that could be restored by fixed screw-retained implant hybrid dentures.
- Patients having a substantial bone height and width at prospective implant sites to install four standard-size inter-foraminal implants.
- Sufficient crown height space according to criteria of all-on-4.
- good oral hygiene and motivation
Who cannot join
- Patients with bad oral hygiene.
- Patients with limited mouth opening.
- Vulnerable groups.
- Uncooperative patients.
- Patients receiving or undergoing radiotherapy or chemotherapy.
- Patients with systemic diseases affecting bone metabolism.
- Smokers
About this study
Official title: Assessment of Accuracy of Full Digital Workflow in Fabrication of Four-Implant Screw-Retained Mandibular Hybrid Prostheses
The goal of this clinical trial study is to evaluate the accuracy of the full digital workflow for four-implant, screw-retained mandibular hybrid prostheses in patients with completely edentulous mandible.
Read the detailed description
The main issues to evaluate are:
- The trueness of full arch digital scans when additional geometric scanning aids are coupled with the scan bodies.
- The trueness of the generated 3D-printed DIMs.
Participants will provide two types of impressions to compare after osteointegration; the first will be conventional open tray impression used as a gold standard comparator, the second will be digital scans with additional geometric scanning aids coupled with the scan bodies.
Accordingly generated 3D-printed DIMs will be printed and compared to the digital image to evaluate its accuracy.
- Conditions
- Denture, Complete Edentulism
- Being tested
- conventional impression stone casts digitization, digital scanning with coupled scanning aiding device, Digital Implant Model assessment of accuracy
- Keywords
- Intraoral scanning, Digital implant models, Edentulous mandible, Screw retained prosthesis, Geometric scanning aids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional impression stone casts digitizationDevice
Nine conventional physical open tray impressions will be poured into a hard dental stone to obtain nine definitive implant casts with conventional implant analogs to act as a reference comparator.
Impressions will be digitized to reference STL files.
digital scanning with coupled scanning aiding deviceDevice
Nine optical impressions will be obtained while additional geometric scanning aids are coupled with the scan bodies to get nine CAD/CAM 3D-printed polymer casts with digital implant analogs.
Digital Implant Model assessment of accuracyDevice
The nine STL files of optical scanning will serve as reference data for comparison with the digitized DIMs to evaluate the accuracy of representation of the actual position of implants in the software.
| Study group | Role | What they receive |
|---|---|---|
| conventional physical impressions | Active comparator | Nine physical open tray impressions will be poured into a hard dental stone to obtain nine definitive implant casts with conventional implant analogs.
The impressions will be scanned to provide a gold standard reference STL files. Receives: Device: conventional impression stone casts digitization |
| optical impressions with additional geometric scanning aids coupled with the scan bodies | Experimental | Nine optical impressions will be obtained while additional geometric scanning aids are coupled with the scan bodies to get nine CAD/CAM 3D-printed polymer casts with digital implant analogs. Receives: Device: digital scanning with coupled scanning aiding device; Device: Digital Implant Model assessment of accuracy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trueness of full arch digital scans when additional geometric scanning aids are coupled with the scan bodies.
The optical impressions will be obtained by an intraoral scanner while the scan abutments are coupled with 3D geometric scanning aids and seated in positions.
special digital software will be used to compare the trueness of virtual implant positions in the obtained digital scan STL files to the digitized reference positions in the patients' digitized conventional stone model
Measured: 2 months
Secondary outcomes (1)
Trueness of the generated 3D-printed digital implant models.
Based on the obtained optical scans, CAD software will be used to produce CAM files of definitive implant casts, the polymer casts will be printed and the digital implant analogs will be installed in their corresponding positions in the printed DIMs.
The digitized data of the DIMs will be compared to their corresponding reference STL files of optical scans to check the accuracy of the generated digital implant models.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study startApr 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DentureStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Hafez Mohamed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281002
- Sponsor's protocol ID
- FDASU-RecIM112323
- Status last verified
- Mar 2024
- First submitted
- 20 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Accuracy of Full Digital Workflow in Fabrication of Four-Implant Screw-Retained Mandibular Hybrid Prostheses
- ClinicalTrials.gov ID
- NCT06281002
- Acronym / sponsor ID
- FDASU-RecIM112323
- Conditions
- Denture, Complete Edentulism
- Keywords
- Intraoral scanning, Digital implant models, Edentulous mandible, Screw retained prosthesis, Geometric scanning aids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Feb 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 goal of this clinical trial study is to evaluate the accuracy of the full digital workflow for four-implant, screw-retained mandibular hybrid prostheses in patients with completely edentulous mandible.
Detailed description
The main issues to evaluate are:
- The trueness of full arch digital scans when additional geometric scanning aids are coupled with the scan bodies.
- The trueness of the generated 3D-printed DIMs.
Participants will provide two types of impressions to compare after osteointegration; the first will be conventional open tray impression used as a gold standard comparator, the second will be digital scans with additional geometric scanning aids coupled with the scan bodies.
Accordingly generated 3D-printed DIMs will be printed and compared to the digital image to evaluate its accuracy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional physical impressions | Active comparator | Device: conventional impression stone casts digitizationNine physical open tray impressions will be poured into a hard dental stone to obtain nine definitive implant casts with conventional implant analogs. The impressions will be scanned to provide a gold standard reference STL files. |
| optical impressions with additional geometric scanning aids coupled with the scan bodies | Experimental | Device: digital scanning with coupled scanning aiding device, Device: Digital Implant Model assessment of accuracyNine optical impressions will be obtained while additional geometric scanning aids are coupled with the scan bodies to get nine CAD/CAM 3D-printed polymer casts with digital implant analogs. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients having a completely edentulous lower arch that could be restored by fixed screw-retained implant hybrid dentures.
- Patients having a substantial bone height and width at prospective implant sites to install four standard-size inter-foraminal implants.
- Sufficient crown height space according to criteria of all-on-4.
- good oral hygiene and motivation
Key exclusion criteria (7 listed)
- Patients with bad oral hygiene.
- Patients with limited mouth opening.
- Vulnerable groups.
- Uncooperative patients.
- Patients receiving or undergoing radiotherapy or chemotherapy.
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 |
|---|---|---|
| conventional impression stone casts digitizationNine conventional physical open tray impressions will be poured into a hard dental stone to obtain nine definitive implant casts with conventional implant analogs to act as a reference comparator. Impressions will be digitized to reference STL files. | Device | conventional physical impressions |
| digital scanning with coupled scanning aiding deviceNine optical impressions will be obtained while additional geometric scanning aids are coupled with the scan bodies to get nine CAD/CAM 3D-printed polymer casts with digital implant analogs. | Device | optical impressions with additional geometric scanning aids coupled with the scan bodies |
| Digital Implant Model assessment of accuracyThe nine STL files of optical scanning will serve as reference data for comparison with the digitized DIMs to evaluate the accuracy of representation of the actual position of implants in the software. | Device | optical impressions with additional geometric scanning aids coupled with the scan bodies |
Primary outcome
Trueness of full arch digital scans when additional geometric scanning aids are coupled with the scan bodies.
Time frame: 2 months
The optical impressions will be obtained by an intraoral scanner while the scan abutments are coupled with 3D geometric scanning aids and seated in positions. special digital software will be used to compare the trueness of virtual implant positions in the obtained digital scan STL files to the digitized reference positions in the patients' digitized conventional stone model
1 secondary outcome
Trueness of the generated 3D-printed digital implant models.
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing conventional impression stone casts digitization, digital scanning with coupled scanning aiding device and Digital Implant Model assessment of accuracy in people with Denture and Complete Edentulism, run by Ain Shams University.
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 7 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 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Trueness of full arch digital scans when additional geometric scanning aids are coupled with the scan bodies. (time frame: 2 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 6 Mar 2024.