Jaw Edentulous
Conditions
Keywords
Subperiosteal Implant, Milled Bar
Brief summary
This study aims to evaluate and compare patient satisfaction and prosthetic complications between two types of prostheses: milled bar and screw-retained prostheses, used for supporting maxillary subperiosteal implants. Patients requiring maxillary rehabilitation using subperiosteal implants will be randomly assigned to receive either a milled bar-retained prosthesis or a screw-retained prosthesis. Patient satisfaction and any prosthetic complications will be clinical assessed and followed up over a one-year period to determine which prosthetic design offers better clinical outcomes and patient experience.
Detailed description
Patients enrolled in this randomized clinical trial will undergo surgical placement of maxillary subperiosteal implants. Following the healing period, patients will be allocated into two treatment groups. Group 1 will receive a milled bar-retained prosthesis, while Group 2 will receive a screw-retained prosthesis. Baseline data and clinical parameters will be recorded. Throughout the one-year follow-up period, patient satisfaction will be evaluated using standardized questionnaires or visual analog scales (VAS). Additionally, prosthetic complications-such as screw loosening, fracture, or bar-related issues-will be closely monitored and documented at regular follow-up intervals to comprehensively compare the two restorative modalities.
Interventions
DEVICEMaxillary subperiosteal implant with milled bar-retained prosthesis
Surgical placement of a custom-milled, patient-specific CAD/CAM maxillary subperiosteal implant. Following the healing and provisional phase, a definitive milled bar-retained overdenture prosthesis will be fabricated and attached to support full-arch rehabilitation.
DEVICEMaxillary subperiosteal implant with screw-retained prosthesis
Surgical placement of a custom-milled, patient-specific CAD/CAM maxillary subperiosteal implant. Following the healing and provisional phase, a definitive screw-retained prosthesis will be fabricated and fixed to support full-arch rehabilitation.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomly allocated into two parallel groups to receive either a milled bar-retained prosthesis or a screw-retained prosthesis
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Severe atrophied maxillary ridge (Residual bone height \< 4mm on CBCT) with the presence of adequate bone volume in the maxilla to support subperiosteal implants. * Willing to attend quarterly follow-ups. * No previous subperiosteal implant history.
Exclusion criteria
* Systemic conditions contraindicating implant therapy. * Poor oral hygiene or ongoing periodontal disease. * Patients who have received hybrid restorations (i.e., a combination of bar and multi-unit systems).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prosthetic Complications | Baseline (immediately following prosthesis placement) and after one year | Aesthetic -mechanical -functional and biological categories |
| Patient satisfaction | Baseline (immediately following prosthesis placement) and after one year | Patient satisfaction will be evaluated using a Visual Analog Scale (VAS), where scores range from 0 to 10. A score of 0 represents complete dissatisfaction, while a score of 10 represents complete satisfaction with the prosthesis |
Countries
Egypt
Outcome results
None listed