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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06620497
Enrollment
8
Registered
2024-10-01
Start date
2021-06-06
Completion date
2024-06-12
Last updated
2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulous Alveolar Ridge in Mandible

Keywords

SFI bar, milled bar, bone loss, mucosal complications, prosthetic complications

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.

Interventions

PROCEDUREstress 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.

PROCEDUREmilled 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.

Sponsors

Fayoum University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* mandibular edentulous ridge

Exclusion criteria

* severe atrophy in mandibular ridge

Design outcomes

Primary

MeasureTime frame
marginal bone losstime of insertion, 6 months, 1 year and 3 years

Secondary

MeasureTime frameDescription
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/replacement3 yearsinclude; 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 bar3 yearsinclude; mucositis/soreness of mandibular mucosa, ulcer of mandibular mucosa, hyperplasia under the bar

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026