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Clinical Trials/NCT06620497
NCT06620497
Completed
Not Applicable

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

Fayoum University1 site in 1 country8 target enrollmentJune 6, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Edentulous Alveolar Ridge in Mandible
Sponsor
Fayoum University
Enrollment
8
Locations
1
Primary Endpoint
marginal bone loss
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
June 6, 2021
End Date
June 12, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Salsabeel A Afifi, PhD

lecturer of oral medicine and periodontology

Fayoum University

Eligibility Criteria

Inclusion Criteria

  • mandibular edentulous ridge

Exclusion Criteria

  • severe atrophy in mandibular ridge

Outcomes

Primary Outcomes

marginal bone loss

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

Secondary Outcomes

  • 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(3 years)
  • mucosal complications include; mucositis/soreness of mandibular mucosa, ulcer of mandibular mucosa, hyperplasia under the bar(3 years)

Study Sites (1)

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