Skip to main content
OpenTrials
Completed

NCT Number: NCT06620497

SFI Bars and Milled Bars Supporting Mandibular Overdentures. Three-year 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Edentulous Alveolar Ridge in Mandible Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

fayoum University

Al Fayyum, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • mandibular edentulous ridge

Exclusion criteria

  • severe atrophy in mandibular ridge

Treatment and study plan

stress free implant bar

Procedure

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.

milled bar

Procedure

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.

Primary outcomes

  1. marginal bone loss

    Time frame: time of insertion, 6 months, 1 year and 3 years

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.