Digital InterventionPhase 2/3NCT07091786
Complete Digital Workflow
A Phase 2/3 study testing Implant supported prosthesis in people with Digital Intervention, run by Mansoura University at 1 site in Egypt.
Trial summary
This study will aim to clinical evaluation of titanium-zirconium and peek-composite of screw retained prosthesis used for rehabilitation of edentulous patients using Complete digital workflow for construction of full arch implant supported screw retained restoration. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Digital Intervention
- What is being tested?
- Implant supported prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2023to 1 Oct 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- i- Edentulous jaws ii- Good oral hygiene and good compliance. iii- Angel's class I maxillo-mandibular relationship and a minimum of 16mm mandibular restorative space at the estimated occlusal vertical dimension. This will be verified by recoding a tentative jaw relation iv- Adequate bone height and width for placement of standard diameter implants. A cone beam computerized tomographic scan will be taken prior to surgery to determine the bone quality and bone volume
- Exclusion Criteria:i- Systemic disease: uncontrolled diabetes mellitus, cardiovascular disease, immunodeficiency disorders, blood disorders such as coagulation disorders, severe osteoporosis, and any metabolic disease that might influence the rate of bone resorption ii- Long-term medication use: steroid, anti-epileptic drugs, drugs favoring gingival overgrowth, bispho- sphonates (bisphosphonate injections or more than 4 years of oral bisphosphonate use), and any medi- cation that influences the rate of bone loss or sur- vival of dental implants. iii- Infection of human immunodeficiency virus, hepatitis B virus, or syphilis iv- Bruxism v- Maxillofacial tumor
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Complete Digital Workflow for Construction of Full Arch Implant Supported Screw Retained Restoration: Clinical Evaluation of Titanium-zirconium Versus Peek-composite
This study will aim to clinical evaluation of titanium-zirconium and peek-composite of screw retained prosthesis used for rehabilitation of edentulous patients using Complete digital workflow for construction of full arch implant supported screw retained restoration.
- Conditions
- Digital Intervention
- Being tested
- Implant supported prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant supported prosthesisDevice
implant supported full arch prosthesis
| Study group | Role | What they receive |
|---|---|---|
| group1 | Active comparator | • the titanium group involved patients who will be received ISFCDs with individual zirconium veneers Receives: Device: Implant supported prosthesis |
| group 2 | Active comparator | The PEEK group included patients who will be received ISFCDs with individual PMMA composite veneers cemented onto a CAD-CAM PEEK framework Receives: Device: Implant supported prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthetic complication
Complication will be evaluated clinically
Measured: one year
Marginal Bone loss
Bone loss will be evaluated Radiographically around dental implants
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 posted29 Jul 2025
- Study start30 Oct 2023
- Primary completion20 Jul 2024
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital InterventionStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091786
- Sponsor's protocol ID
- J0204023RP
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complete Digital Workflow for Construction of Full Arch Implant Supported Screw Retained Restoration: Clinical Evaluation of Titanium-zirconium Versus Peek-composite
- ClinicalTrials.gov ID
- NCT07091786
- Acronym / sponsor ID
- J0204023RP
- Conditions
- Digital Intervention
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 29 Jul 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.
This study will aim to clinical evaluation of titanium-zirconium and peek-composite of screw retained prosthesis used for rehabilitation of edentulous patients using Complete digital workflow for construction of full arch implant supported screw retained restoration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group1 | Active comparator | Device: Implant supported prosthesis• the titanium group involved patients who will be received ISFCDs with individual zirconium veneers |
| group 2 | Active comparator | Device: Implant supported prosthesisThe PEEK group included patients who will be received ISFCDs with individual PMMA composite veneers cemented onto a CAD-CAM PEEK framework |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- i- Edentulous jaws ii- Good oral hygiene and good compliance. iii- Angel's class I maxillo-mandibular relationship and a minimum of 16mm mandibular restorative space at the estimated occlusal vertical dimension. This will be verified by recoding a tentative jaw relation iv- Adequate bone height and width for placement of standard diameter implants. A cone beam computerized tomographic scan will be taken prior to surgery to determine the bone quality and bone volume
- Exclusion Criteria:i- Systemic disease: uncontrolled diabetes mellitus, cardiovascular disease, immunodeficiency disorders, blood disorders such as coagulation disorders, severe osteoporosis, and any metabolic disease that might influence the rate of bone resorption ii- Long-term medication use: steroid, anti-epileptic drugs, drugs favoring gingival overgrowth, bispho- sphonates (bisphosphonate injections or more than 4 years of oral bisphosphonate use), and any medi- cation that influences the rate of bone loss or sur- vival of dental implants. iii- Infection of human immunodeficiency virus, hepatitis B virus, or syphilis iv- Bruxism v- Maxillofacial tumor
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Implant supported prosthesisimplant supported full arch prosthesis | Device | group 2, group1 |
Primary outcome
Prosthetic complication
Time frame: one year
Complication will be evaluated clinically
Marginal Bone loss
Time frame: one year
Bone loss will be evaluated Radiographically around dental implants
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
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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.
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 Phase 2/3 study testing Implant supported prosthesis in people with Digital Intervention, run by Mansoura 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 3 inclusion and 0 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: enrolling by invitation, as of the sponsor's last update on 29 Jul 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Prosthetic complication (time frame: one year). The study lists 2 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 29 Jul 2025.