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)

March 6, 2025 updated by: Esraa Khaled Hassan Mahdy, Cairo University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Dentistry, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
Other Names:
  • single piece implants
  • mono implenats
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

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.

Other Names:
  • endosteal implants
  • root form implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peri-implant marginal bone loss
Time Frame: From implant placement (baseline) and After 3 months (after the osseointegration phase)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

January 18, 2025

First Submitted That Met QC Criteria

January 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • one-piece implants

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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