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