SFI Bars and Milled Bars Supporting Mandibular Overdentures. Three-year Randomized Clinical Trial

September 29, 2024 updated by: Salsabeel A Afifi, PhD, Fayoum University

Marginal Bone Loss, Prosthetic and Mucosal Complications of Stress-free Implant Bars and Milled Bars Supporting Mandibular Overdentures. Three-years Randomized Clinical Trial

The aim of this study will be to evaluate the marginal bone loss and prosthetic complications of stress-free implant (SFI) and milled bars used to assist mandibular 4-implant overdentures after 3 years

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Eight edentulous participants with insufficient stability of mandibular dentures will receive 4 implants in the mandibular ridge (2 implants in the canine areas and 2 implants in the first molar areas), and then after 3 months, patients will be randomly assigned into 2 groups; 1) group 1: will include 4 participants who will receive milled bar overdentures, and 2) group 2: will include 4 participants who will receive SFI bar overdentures. For both groups, marginal bone loss will be evaluated using the standardized digital periapical films at the time of insertion, 6 months, 1 year, and 3 years after insertion. Prosthetic and mucosal complications will be evaluated after 3 years.

Study Type

Interventional

Enrollment (Actual)

8

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 Locations

  • Egypt
      • Fayoum, Egypt
        • Fayoum 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:

  • mandibular edentulous ridge

Exclusion Criteria:

  • severe atrophy in mandibular ridge

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SFI group
Procedure: stress free implant bar
SFI bar was sectioned and adjusted on the model for more convenience and to save the time of the appointment. The bar (Cendres Metaux, Switzerland) abutments were screwed to the implant analogues.
Active Comparator: milled bar group
Procedure: milled bar
bar abutments were attached to the analogues and scan bodies were threaded into the bar abutments. The cast was scanned using a lab scanner (Ceramill, Amann Girrbach, Germany). The milled bar was selected from the software (Exocad DentalCAD) and designed digitally to connect the implants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
marginal bone loss
Time Frame: time of insertion, 6 months, 1 year and 3 years
time of insertion, 6 months, 1 year and 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prosthetic complications as denture fracture, adjustment of denture margins, acrylic teeth wear/fracture, abutment fracture, abutment screw loosening/fracture, prosthetic screw loosening/fracture, metal housing loosening/wear, clip wear/replacement
Time Frame: 3 years
include; denture fracture, adjustment of denture margins, acrylic artificial teeth wear or fracture, abutment fracture, abutment screw loosening or fracture, prosthetic screw loosening or fracture, metal housing loosening or wear, plastic clip wear or replacement.
3 years
mucosal complications include; mucositis/soreness of mandibular mucosa, ulcer of mandibular mucosa, hyperplasia under the bar
Time Frame: 3 years
include; mucositis/soreness of mandibular mucosa, ulcer of mandibular mucosa, hyperplasia under the bar
3 years

Collaborators and Investigators

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

Sponsor

Fayoum University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

June 6, 2021

Primary Completion (Actual)

June 12, 2024

Study Completion (Actual)

June 12, 2024

Study Registration Dates

First Submitted

September 24, 2024

First Submitted That Met QC Criteria

September 29, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 29, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2492024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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