NCT06790524

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

Evaluation of Peri-implant Bone Changes Around One-piece Implant and Two-piece Implants Supporting Mandibular Screw-retained All-On-Four Full Arch Prosthesis: a Randomized Controlled Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	One-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
DEVICE	Two-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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-03-01
• Completion: 2025-10-01
• First posted: 2025-01-24
• Last updated: 2025-03-07

Locations

1 site across 1 country: Egypt