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Enrolling by invitationNCT07091786Updated Jul 29, 2025

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A Phase 2/3 interventional study of Implant supported prosthesis in Digital Intervention, sponsored by Mansoura University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 45 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-29.

Sponsored by Mansoura University · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Oct 2023, registered Jul 2025).
Phase
Phase 2/3
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
45 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Digital Intervention
03

In context

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • 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

-

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
15 participants (estimated)

Study arms

  • Active comparator
    group1

    • the titanium group involved patients who will be received ISFCDs with individual zirconium veneers

    Device: Implant supported prosthesis

  • Active comparator
    group 2

    The PEEK group included patients who will be received ISFCDs with individual PMMA composite veneers cemented onto a CAD-CAM PEEK framework

    Device: Implant supported prosthesis

Interventions

  • DeviceImplant supported prosthesis

    implant supported full arch prosthesis

06

What researchers measure

Primary outcomes

  1. Prosthetic complication

    Complication will be evaluated clinically

    Time frame: one year

  2. Marginal Bone loss

    Bone loss will be evaluated Radiographically around dental implants

    Time frame: one year

07

Study locations

1 site
  • Mansoura University
    Al Mansurah, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07091786
Lead sponsor
Mansoura University
Responsible party
Sponsor
First posted
Jul 29, 2025
Start date
Oct 30, 2023
Primary completion
Jul 20, 2024
Completion
Oct 1, 2025 (estimated)
Last update
Jul 29, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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