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

Not Applicable

Completed

• Conditions: Edentulous Alveolar Ridge in Mandible
• Interventions: Procedure: stress free implant bar; Procedure: milled bar

• Registration Number: NCT06620497
• Lead Sponsor: Fayoum University

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.

Study Timeline

• Study Start: 2021-06-06
• Primary Completion: 2024-06-12
• Study Completion: 2024-06-12
• Status Verified: 2024-09
• Study First Submitted: 2024-09-24
• Study First Submitted QC: 2024-09-29
• Last Update Submitted: 2024-09-29
• Study First Posted: 2024-10-01
• Last Update Posted: 2024-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• mandibular edentulous ridge

Exclusion Criteria

• severe atrophy in mandibular ridge

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SFI group	stress free implant bar	-
milled bar group	milled bar	-

Primary Outcome Measures

Name	Time	Method
marginal bone loss	time of insertion, 6 months, 1 year and 3 years

Secondary Outcome Measures

Name	Time	Method
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	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.
mucosal complications include; mucositis/soreness of mandibular mucosa, ulcer of mandibular mucosa, hyperplasia under the bar	3 years	include; mucositis/soreness of mandibular mucosa, ulcer of mandibular mucosa, hyperplasia under the bar

Trial Locations

Locations (1)

fayoum University; 🇪🇬 Fayoum, Egypt