Patient Satisfaction and Prosthetic Complications of the Milled Bar Versus Screw-Retained Prostheses for Maxillary Subperiosteal Implants: A One Year Randomized Clinical Trial

NCT07632885 — Not applicable, Active not recruiting, 20 participants, Mansoura University

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Registry	NCT07632885
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	20 (Actual)
Sponsor	Mansoura University (Other)
Conditions	Jaw Edentulous
Interventions	Maxillary subperiosteal implant with milled bar-retained prosthesis, Maxillary subperiosteal implant with screw-retained prosthesis (Device)
Dates	start 2025-06-01, primary completion 2026-10-01 (estimated), completion 2026-11-01 (estimated), first posted 2026-06-08, last updated 2026-06-08
Locations	1 site in Egypt

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Group 1: Milled Bar-Retained Prosthesis	Experimental	Device: Maxillary subperiosteal implant with milled bar-retained prosthesis	Patients in this group will receive a milled bar-retained prosthesis supported by maxillary subperiosteal implants. Patient satisfaction and prosthetic complications will be evaluated over a one-year follow-up period.
Group 2: Screw-Retained Prosthesis	Experimental	Device: Maxillary subperiosteal implant with screw-retained prosthesis	Patients in this group will receive a screw-retained prosthesis supported by maxillary subperiosteal implants. Patient satisfaction and prosthetic complications will be evaluated over a one-year follow-up period

Maxillary subperiosteal implant with milled bar-retained prosthesis (Device), also known as Custom CAD/CAM subperiosteal implant overdenture: 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.
Maxillary subperiosteal implant with screw-retained prosthesis (Device): 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.

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 50 Years to 70 Years

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).

+Locations (1)

Facility	City	Country	Status
Faculty of Dentistry of Mansoura University	Al Mansurah, Dakahlia Governorate	Egypt