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

NCT06790524 | Not Yet Recruiting DMC

• 1 other identifier: one-piece implants
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

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

Outcome Measures

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.

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

Study Arms (2)

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

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

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

One-piece dental implants with MUA DEVICE

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

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

Two-piece dental implants DEVICE

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

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry, Cairo University

Cairo, Egypt

Location

Central Study Contacts

Esraa kh Mahdy

CONTACT

+201128616565; esraa.hassen@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master degree candidate at Cairo university

Study Record Dates

• First Submitted: January 18, 2025
• First Posted: January 24, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)