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Not yet recruitingNCT06790524RCTUpdated Mar 7, 2025

Comparative Evaluation Between One-piece and Two-piece Implants Supporting Mandibular Screw-retained All-On-Four Full-arch Prosthesis on Peri-implant Bone Changes.

An interventional study of One-piece dental implants with MUA and Two-piece dental implants in Marginal Bone Loss and One-piece Implants Versus Two-piece Implants During the Osseointegration Phase, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-03-07.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Evaluating the bone changing after receiving one-piece implants supported full arch prosthesis compared to the conventional two-piece implants.

Read the detailed description

Studying the difference between one-piece and two-piece implants and their effect on bone loss. This will help in simplifying the surgical procedure for full arch implant-supported prosthesis rehabilitation using one-piece implants, eliminating the disturbance of the gum tissue around the implants, potentially reducing the risk of bacterial colonization and inflammation.

02

Conditions studied

  • Marginal Bone Loss
  • One-piece Implants Versus Two-piece Implants During the Osseointegration Phase

Keywords

  • one-piece implants , All-On-Four, Marginal bone loss
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Completely edentulous patients, who can sign an informed consent will be considered eligible for this trial.
  • Residual bone height should have sufficient volume and quality for implant placement with a minimum of 12-14 mm in height and 6 mm in width.
  • Patients who already have existing maxillary and mandibular complete dentures, and after examination of the mandibular dentures, technical problems concerning denture design and/or occlusion are found, or who are dissatisfied with the retention and stability of their technically satisfactory mandibular dentures.

Exclusion criteria

Exclusion Criteria:

    • Patients with conditions that may contraindicate implant placement (e.g., Immunosuppressed or immunocompromised patients, patients under treatment of intravenous amino bisphosphonates, patients undergoing radiotherapy to the head and neck region).
  • Inadequate mouth opening
  • Heavy smokers, more than 10 cigarettes/day
  • Patients with poor oral hygiene and motivation.
  • Pregnancy or nursing.
  • Drug abusers.
  • Psychiatric problems or unrealistic expectations.
  • Patients with infection and or inflammation in the area intended for implant placement.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
22 participants (estimated)

Study arms

  • Experimental
    Patients will receive an implant screw-retained restoration supported by One-piece implants.

    One-piece dental implants with multi-unit abutments mounted on them, provided with different implant-abutment angulation which makes them utilizable for All-On-Four prosthesis.

    Device: One-piece dental implants with MUA

  • Active comparator
    Patients will receive an implant screw-retained restoration supported by two-piece implants.

    Two-piece Implants, Implant fixtures, and separate pieces of Multi-unit abutments with different angulations will be used to support the All-On-Four prostheiss.

    Device: Two-piece dental implants

Interventions

  • DeviceOne-piece dental implants with MUA

    one-piece dental implants with multi-units abutment mounted on the implants as a single piece provided with different abutment angulation utilizing these implants for All-On-Four prothesis

    Also known as: single piece implants, mono implenats

  • DeviceTwo-piece dental implants

    Surgical and immediate loading procedures: On the day of implant placement, patients will receive two-piece implant. After crestal incision and full-thickness flap elevation, the implant sites will be prepared aided by a surgical template. 4 implants will be placed, two aligned in an axial orientation and two will be distally aligned (17 degrees). The standard placement procedure as recommended by the manufacturer will be used. The surgical drills with increasing diameters will be used to prepare the implant sites. Implants will be ideally placed at bone level (or 1 mm deeper depending on the soft tissue thickness). After 3 months as a healing phase, a definitive prosthesis will be fabricated using the same abutments, and the marginal bone loss after the osseointegration phase will be assessed.

    Also known as: endosteal implants, root form implants

06

What researchers measure

Primary outcomes

  1. Peri-implant marginal bone loss

    Peri-implant marginal bone loss will be assessed utilizing CBCT. The radiographic evaluation will be performed at baseline and at 3 months after functional loading. Using the first thread of the implant as a standard reference point, the circumference of the Crestal bone level around the implant will be measured in all directions (mesial, distal, buccal, and lingual) in width and height.

    Time frame: From implant placement (baseline) and After 3 months (after the osseointegration phase)

07

Study locations

1 site
  • Faculty of dentistry, Cairo University
    Cairo, 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 Mar 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06790524
Lead sponsor
Cairo University
Responsible party
Esraa Khaled Hassan Mahdy (Master degree candidate at Cairo university, Cairo University) — Principal investigator
First posted
Jan 24, 2025
Start date
Mar 2025 (estimated)
Primary completion
Mar 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
Mar 7, 2025

Study contacts

Esraa kh Mahdy
Contact
esraa.hassen@dentistry.cu.edu.eg
+201128616565

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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