Passivity of Co-Cr Full-arch Maxillary Prostheses Via IOSNCT07370701
Passivity of Full-Arch Co-Cr Maxillary Prostheses Using IOS
A study testing Open tray impression technique, Auxiliary Geometric Device (M600) and Auxiliary Geometric Device (PS) in people with Passivity of Co-Cr Full-arch Maxillary Prostheses Via IOS, run by Ain Shams University at 1 site in Egypt.
Trial summary
Statement of the problem: Accurate digital scans of edentulous patients is challenging due to the absence of anatomic landmarks and geometric variations along the dental arch. Whether adding an auxiliary geometric device (AGD) will improve scanning is unclear. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Passivity of Co-Cr Full-arch Maxillary Prostheses Via IOS
- What is being tested?
- Open tray impression technique, Auxiliary Geometric Device (M600) and Auxiliary Geometric Device (PS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Jun 2023to 5 Sep 2025
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For a maxillary edentulous patient, the last extraction should be at least six months
- Non-smokers
- 50-70 years of age
- Have good oral hygiene and motivation.
Who cannot join
- Patients with major systemic diseases that may affect osseointegration
- Uncontrolled diabetes mellitus
- The need for extensive bone grafting in the planned implant site
- Pregnant female patient
- Under bisphosphonate treatment
- Limited mouth-opening for executing the guided implant surgery.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Ain Shams University
Cairo, Organization of African Unity Street,, 02
About this study
Official title: Evaluation of Passivity of Co-Cr Complete Arch Screw Retained Maxillary Prostheses Using Different Intraoral Scanners With the Aid of Auxiliary Geometric Device
Statement of the problem: Accurate digital scans of edentulous patients is challenging due to the absence of anatomic landmarks and geometric variations along the dental arch. Whether adding an auxiliary geometric device (AGD) will improve scanning is unclear.
Purpose: The aim of the study is to analyze the accuracy of complete-arch digital scans of completely edentulous arches by placing auxiliary geometric device.
Material and Methods: This in vivo study included patients who received complete arch screw-retained prostheses supported by 4 implants. Seven patients were randomly chosen; a dual scan protocol was performed for digital implant planning. Surgical guide and AGD were 3d printed. Three different data acquisition methods for each individual: Open tray impression digitized by extraoral scanner (EO Group), Intraoral scan by using Medit i600 with AGD (M600 Group), and Intraoral scan (CEREC Primescan; Dentsply Sirona) with AGD (PS Group). A reference model was formed to check the accuracy of these 3 data acquisitions. The framework was designed and printed for the 3 groups to be placed in the reference model to check the passivity. Passivity was tested through modified 1-screw test by measuring the marginal gap by using a digital camera (add magnification). Each framework was placed in the patient's mouth to re-check the passivity, the best one was delivered to the patient after 4 months after osteointegration of the implants.
- Being tested
- Open tray impression technique, Auxiliary Geometric Device (M600), Auxiliary Geometric Device (PS)
- Keywords
- intraoral scanner, Auxiliary geometric device, All on 4 maxilla, modified screw test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open tray impression techniqueOther
dental implant then open tray impression technique
Auxiliary Geometric Device (M600)Other
analyze the accuracy and passivity of complete-arch digital scans of completely edentulous arches by placing auxiliary geometric device
Auxiliary Geometric Device (PS)Other
analyze the accuracy and passivity of complete-arch digital scans of completely edentulous arches by placing auxiliary geometric device
| Study group | Role | What they receive |
|---|---|---|
| Open tray impression digitized by extraoral scanner (EO Group) | Experimental | A reference model was formed to check the accuracy of these 3 data acquisitions. The framework was designed and printed for the 3 groups to be placed in the reference model to check the passivity. Passivity was tested through modified 1-screw test by measuring the marginal gap by using a digital camera (add magnification). Each framework was placed in the patient's mouth to re-check the passivity, the best one was delivered to the patient after 4 months after osteointegration of the implants. Receives: Other: Open tray impression technique |
| Intraoral scan by using Medit i600 with AGD (M600 Group) | Experimental | A reference model was formed to check the accuracy of these 3 data acquisitions. The framework was designed and printed for the 3 groups to be placed in the reference model to check the passivity. Passivity was tested through modified 1-screw test by measuring the marginal gap by using a digital camera (add magnification). Each framework was placed in the patient's mouth to re-check the passivity, the best one was delivered to the patient after 4 months after osteointegration of the implants. Receives: Other: Auxiliary Geometric Device (M600) |
| Intraoral scan (CEREC Primescan; Dentsply Sirona) with AGD (PS Group) | Experimental | A reference model was formed to check the accuracy of these 3 data acquisitions. The framework was designed and printed for the 3 groups to be placed in the reference model to check the passivity. Passivity was tested through modified 1-screw test by measuring the marginal gap by using a digital camera (add magnification). Each framework was placed in the patient's mouth to re-check the passivity, the best one was delivered to the patient after 4 months after osteointegration of the implants. Receives: Other: Auxiliary Geometric Device (PS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimate the marginal gap using digital camera
modified single screw test to check the passivity of the 3 frameworks in both the models and in the patient's mouth by radiograph
Measured: after 4 months after osteointegration of the implants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start8 Jun 2023
- Primary completion5 Mar 2025
- Study completion5 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Passivity of Co-Cr Full-arch Maxillary Prostheses Via IOSStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmine Hamdy Abdel-Hay Dawood, Ain Shams University
- Investigators
- Yasmin H Abd El Hay Dawoud, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370701
- Sponsor's protocol ID
- FDASU-RecID022318
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 27 Jan 2026
- 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 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Passivity of Co-Cr Complete Arch Screw Retained Maxillary Prostheses Using Different Intraoral Scanners With the Aid of Auxiliary Geometric Device
- ClinicalTrials.gov ID
- NCT07370701
- Acronym / sponsor ID
- FDASU-RecID022318
- Keywords
- intraoral scanner, Auxiliary geometric device, All on 4 maxilla, modified screw test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 5 Sep 2025 (actual)
- First posted
- 27 Jan 2026 (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.
Statement of the problem: Accurate digital scans of edentulous patients is challenging due to the absence of anatomic landmarks and geometric variations along the dental arch. Whether adding an auxiliary geometric device (AGD) will improve scanning is unclear.
Purpose: The aim of the study is to analyze the accuracy of complete-arch digital scans of completely edentulous arches by placing auxiliary geometric device.
Material and Methods: This in vivo study included patients who received complete arch screw-retained prostheses supported by 4 implants. Seven patients were randomly chosen; a dual scan protocol was performed for digital implant planning. Surgical guide and AGD were 3d printed. Three different data acquisition methods for each individual: Open tray impression digitized by extraoral scanner (EO Group), Intraoral scan by using Medit i600 with AGD (M600 Group), and Intraoral scan (CEREC Primescan; Dentsply Sirona) with AGD (PS Group). A reference model was formed to check the accuracy of these 3 data acquisitions. The framework was designed and printed for the 3 groups to be placed in the reference model to check the passivity. Passivity was tested through modified 1-screw test by measuring the marginal gap by using a digital camera (add magnification). Each framework was placed in the patient's mouth to re-check the passivity, the best one was delivered to the patient after 4 months after osteointegration of the implants.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open tray impression digitized by extraoral scanner (EO Group) | Experimental | Other: Open tray impression techniqueA reference model was formed to check the accuracy of these 3 data acquisitions. The framework was designed and printed for the 3 groups to be placed in the reference model to check the passivity. Passivity was tested through modified 1-screw test by measuring the marginal gap by using a digital camera (add magnification). Each framework was placed in the patient's mouth to re-check the passivity, the best one was delivered to the patient after 4 months after osteointegration of the implants. |
| Intraoral scan by using Medit i600 with AGD (M600 Group) | Experimental | Other: Auxiliary Geometric Device (M600)A reference model was formed to check the accuracy of these 3 data acquisitions. The framework was designed and printed for the 3 groups to be placed in the reference model to check the passivity. Passivity was tested through modified 1-screw test by measuring the marginal gap by using a digital camera (add magnification). Each framework was placed in the patient's mouth to re-check the passivity, the best one was delivered to the patient after 4 months after osteointegration of the implants. |
| Intraoral scan (CEREC Primescan; Dentsply Sirona) with AGD (PS Group) | Experimental | Other: Auxiliary Geometric Device (PS)A reference model was formed to check the accuracy of these 3 data acquisitions. The framework was designed and printed for the 3 groups to be placed in the reference model to check the passivity. Passivity was tested through modified 1-screw test by measuring the marginal gap by using a digital camera (add magnification). Each framework was placed in the patient's mouth to re-check the passivity, the best one was delivered to the patient after 4 months after osteointegration of the implants. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- For a maxillary edentulous patient, the last extraction should be at least six months
- Non-smokers
- 50-70 years of age
- Have good oral hygiene and motivation.
Key exclusion criteria (6 listed)
- Patients with major systemic diseases that may affect osseointegration
- Uncontrolled diabetes mellitus
- The need for extensive bone grafting in the planned implant site
- Pregnant female patient
- Under bisphosphonate treatment
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 |
|---|---|---|
| Open tray impression techniquedental implant then open tray impression technique | Other | Open tray impression digitized by extraoral scanner (EO Group) |
| Auxiliary Geometric Device (M600)analyze the accuracy and passivity of complete-arch digital scans of completely edentulous arches by placing auxiliary geometric device | Other | Intraoral scan by using Medit i600 with AGD (M600 Group) |
| Auxiliary Geometric Device (PS)analyze the accuracy and passivity of complete-arch digital scans of completely edentulous arches by placing auxiliary geometric device | Other | Intraoral scan (CEREC Primescan; Dentsply Sirona) with AGD (PS Group) |
Primary outcome
estimate the marginal gap using digital camera
Time frame: after 4 months after osteointegration of the implants
modified single screw test to check the passivity of the 3 frameworks in both the models and in the patient's mouth by radiograph
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 27 Jan 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Yasmin H Abd El Hay Dawoud principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open tray impression technique, Auxiliary Geometric Device (M600) and Auxiliary Geometric Device (PS) in people with Passivity of Co-Cr Full-arch Maxillary Prostheses Via IOS, 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 6 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 27 Jan 2026. 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?
estimate the marginal gap using digital camera (time frame: after 4 months after osteointegration of the implants). 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 27 Jan 2026; AzTrials last refreshed its copy on 1 Nov 2026.