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
1 other identifier
interventional
8
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2024
CompletedFirst Submitted
Initial submission to the registry
September 24, 2024
CompletedFirst Posted
Study publicly available on registry
October 1, 2024
CompletedOctober 1, 2024
September 1, 2024
3 years
September 24, 2024
September 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
marginal bone loss
time of insertion, 6 months, 1 year and 3 years
Secondary Outcomes (2)
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 Arms (2)
SFI group
EXPERIMENTALmilled bar group
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- mandibular edentulous ridge
You may not qualify if:
- severe atrophy in mandibular ridge
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
fayoum University
Al Fayyum, Egypt
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of oral medicine and periodontology
Study Record Dates
First Submitted
September 24, 2024
First Posted
October 1, 2024
Study Start
June 6, 2021
Primary Completion
June 12, 2024
Study Completion
June 12, 2024
Last Updated
October 1, 2024
Record last verified: 2024-09