EdentulismNCT07106177
Three-dimensional Accuracy of Direct Digital Scanning for All on Four Implants in Comparison to a Custom-made Verification Jig in Fully Edentulous Patients
A study testing Scanning with verification jig and Direct intraoral scanning in people with Edentulism, run by Yasser Ahmed at 1 site in Egypt.
Trial summary
The aim of this study is to assess the three-dimensional accuracy of direct intraoral scanning in All-on-4 implant-supported prostheses by comparing intraoral scan data with a custom-made verification jig. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Edentulism
- What is being tested?
- Scanning with verification jig and Direct intraoral scanning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jun 2024to 10 Jul 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with complete mandibular edentulism.
- Patients requiring full-arch rehabilitation with an All-on-4 implant concept.
- Absence of systemic conditions that could affect bone healing or osseointegration.
- Adequate bone volume in the anterior mandible for implant placement without the need for additional grafting.
- Patients capable of maintaining oral hygiene
Who cannot join
- Patients with uncontrolled systemic diseases (e.g., diabetes, osteoporosis).
- History of head and neck radiation therapy.
- Severe parafunctional habits (e.g., bruxism).
- Patients with inadequate bone volume requiring extensive grafting procedures.
- Active periodontal or oral infections.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to assess the three-dimensional accuracy of direct intraoral scanning in All-on-4 implant-supported prostheses by comparing intraoral scan data with a custom-made verification jig.
- Conditions
- Edentulism
- Being tested
- Scanning with verification jig, Direct intraoral scanning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scanning with verification jigOther
Comparing Relative Implant Positions of the 4 implants in each case obtained through desktop scanning of intraoral provisional verification jig. All-on-4 treatment for mandibular and maxillary edentulous cases were scanned using the Medit i700 intraoral scanner. Scan data were imported into Exocad software, where scan-body matching was performed using the Neodent library to determine the positions of multiunit abutment analogues.
Direct intraoral scanningOther
Comparing Relative Implant Positions of the 4 implants in each case obtained through direct intraoral scanning without jig. All-on-4 treatment for mandibular and maxillary edentulous cases were scanned using the Medit i700 intraoral scanner. Scan data were imported into Exocad software, where scan-body matching was performed using the Neodent library to determine the positions of multiunit abutment analogues.
| Study group | Role | What they receive |
|---|---|---|
| Scanning with the aid of jig | Experimental | Not described Receives: Other: Scanning with verification jig |
| Scanning without jig | Active comparator | Not described Receives: Other: Direct intraoral scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical Deviation
Analogues Saved from the Intraoral scan and those saved from stone model were superimposed. The vertical discrepancy (mm) in implant position between intraoral digital scanning and verification jig-based stone model in All-on-4 implant cases.
Measured: through study completion, an average of 1 year
Angular deviation
Analogues Saved from the Intraoral scan and those saved from stone model were superimposed. The angular difference (degrees) in implant position between intraoral digital scanning and verification jig-based stone model in All-on-4 implant cases.
Measured: through study completion, an average of 1 year
Horizontal deviation
Analogues Saved from the Intraoral scan and those saved from stone model were superimposed. The horizontal discrepancy (mm) in implant position between intraoral digital scanning and verification jig-based stone model in All-on-4 implant cases.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start3 Jun 2024
- Primary completion10 Jul 2025
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdentulismStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yasser Ahmed
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor-investigator, Yasser Ahmed, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106177
- Sponsor's protocol ID
- 1093-05/2025
- Status last verified
- Aug 2025
- First submitted
- 22 Jul 2025
- Last updated
- 6 Aug 2025
- 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 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Accuracy of Direct Digital Scanning for All on Four Implants in Comparison to a Custom-made Verification Jig in Fully Edentulous Patients
- ClinicalTrials.gov ID
- NCT07106177
- Acronym / sponsor ID
- 1093-05/2025
- Conditions
- Edentulism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Yasser AhmedUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 6 Aug 2025 (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 aim of this study is to assess the three-dimensional accuracy of direct intraoral scanning in All-on-4 implant-supported prostheses by comparing intraoral scan data with a custom-made verification jig.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scanning with the aid of jig | Experimental | Other: Scanning with verification jig |
| Scanning without jig | Active comparator | Other: Direct intraoral scanning |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with complete mandibular edentulism.
- Patients requiring full-arch rehabilitation with an All-on-4 implant concept.
- Absence of systemic conditions that could affect bone healing or osseointegration.
- Adequate bone volume in the anterior mandible for implant placement without the need for additional grafting.
- Patients capable of maintaining oral hygiene
Key exclusion criteria (5 listed)
- Patients with uncontrolled systemic diseases (e.g., diabetes, osteoporosis).
- History of head and neck radiation therapy.
- Severe parafunctional habits (e.g., bruxism).
- Patients with inadequate bone volume requiring extensive grafting procedures.
- Active periodontal or oral infections.
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 |
|---|---|---|
| Scanning with verification jigComparing Relative Implant Positions of the 4 implants in each case obtained through desktop scanning of intraoral provisional verification jig. All-on-4 treatment for mandibular and maxillary edentulous cases were scanned using the Medit i700 intraoral scanner. Scan data were imported into Exocad software, where scan-body matching was performed using the Neodent library to determine the positions of multiunit abutment analogues. | Other | Scanning with the aid of jig |
| Direct intraoral scanningComparing Relative Implant Positions of the 4 implants in each case obtained through direct intraoral scanning without jig. All-on-4 treatment for mandibular and maxillary edentulous cases were scanned using the Medit i700 intraoral scanner. Scan data were imported into Exocad software, where scan-body matching was performed using the Neodent library to determine the positions of multiunit abutment analogues. | Other | Scanning without jig |
Primary outcome
Vertical Deviation
Time frame: through study completion, an average of 1 year
Analogues Saved from the Intraoral scan and those saved from stone model were superimposed. The vertical discrepancy (mm) in implant position between intraoral digital scanning and verification jig-based stone model in All-on-4 implant cases.
Angular deviation
Time frame: through study completion, an average of 1 year
Analogues Saved from the Intraoral scan and those saved from stone model were superimposed. The angular difference (degrees) in implant position between intraoral digital scanning and verification jig-based stone model in All-on-4 implant cases.
Horizontal deviation
Time frame: through study completion, an average of 1 year
Analogues Saved from the Intraoral scan and those saved from stone model were superimposed. The horizontal discrepancy (mm) in implant position between intraoral digital scanning and verification jig-based stone model in All-on-4 implant cases.
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 6 Aug 2025.
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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 Scanning with verification jig and Direct intraoral scanning in people with Edentulism, run by Yasser Ahmed 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 5 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 6 Aug 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?
Vertical Deviation (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 Aug 2025.