Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
Healthy Volunteers
NCT05924386

Marginal Bone Changes in Fixed All-on-Four Mandibular Prosthesis Using OT Bridge Attachment System

Led by Cairo University · Updated on 2025-04-25

20

Participants Needed

2

Research Sites

60 weeks

Total Duration

On this page

Sponsors

C

Cairo University

Lead Sponsor

B

British University In Egypt

Collaborating Sponsor

AI-Summary

What this Trial Is About

Group I (control) Edentulous mandible receiving all on four fixed mandibular prosthesis using conventionally screw retained multiunit abutments. Group II (intervention) Edentulous mandible receiving all on four fixed prostheses using OT bridge attachments system. For both groups, the implant sites will be prepared aided by the surgical template. 4 implants with length 11-13 mm will be placed, two anterior implants will be aligned in an axial orientation and two posterior implants will be distally aligned according to the all-on-four concept in the inter foraminal area. Implants will be ideally placed at bone level. For both groups: After implant placement and surgical guide removal, healing abutments ( will be connected during healing periods (eight to twelve weeks). Group I ( control) After eight to twelve weeks from implant placement, multiunit abutments with appropriate heights and angulations will be connected to the implants. Group II ( intervention) After eight to twelve weeks from implant placement, narrow- and low-profile OT Equator abutment will be screwed onto the implants according to the manufacturer. marginal bone changes and prosthetic complications are the outcomes Radiographic follow up will be performed for marginal bone changes Serial of standardized digital periapical radiographs using will be taken at the time fixed prosthesis insertion (baseline), 3,6,9,12 months. Type and incidence of prosthetic complications for the prothesis for each group will be evaluated in 3, 6,9 and 12 months, these complications included: loosening or fracture of the prosthetic screw, prosthesis mobility and fracture of the prosthesis.

CONDITIONS

Official Title

Marginal Bone Changes in Fixed All-on-Four Mandibular Prosthesis Using OT Bridge Attachment System

Who Can Participate

Age: 40Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with completely edentulous jaws
  • Aged 40 years or older
  • Sufficient inter-arch space of at least 13 mm
  • Good oral hygiene
  • Minimum bone height of 10 mm and bone diameter of 6 mm or more
Not Eligible

You will not qualify if you...

  • General contraindications for oral surgery
  • Heavy smokers (more than 20 cigarettes per day)
  • Local acute or chronic infections
  • Substance abuse including drugs or alcohol
  • Neuromuscular or psychiatric disorders
  • Treatment with intravenous bisphosphonates
  • Radiation therapy to the head or neck within the past 5 years
  • Diabetes with HbA1c greater than 7.5%

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Faculty of Oral and Dental Medicine, Cairo University

Cairo, Egypt, 002

Actively Recruiting

2

Faculty of Oral and Dental Medicine, Cairo University

Cairo, Egypt, 002

Actively Recruiting

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Research Team

N

nesma O elmosallamy, LECTURER ASSISTANT

CONTACT

N

nada O elmosallamy

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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