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

Cairo University (CU)

Status: Not yet enrolling

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

Treatments: Device: One-piece dental implants with MUA; Device: Two-piece dental implants

Study type: Interventional

Funder types: Other

Identifiers

NCT06790524

one-piece implants

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

• • 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Device: One-piece dental implants with MUA

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

Active Comparator group

Description:

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.

Treatment:

Device: Two-piece dental implants