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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Jaw Edentulous
• Intervention / Treatment: Device: Maxillary subperiosteal implant with milled bar-retained prosthesis; Device: Maxillary subperiosteal implant with screw-retained prosthesis

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia Governorate
    • Al Mansurah, Dakahlia Governorate, Egypt, 35511
      • Faculty of Dentistry of Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: 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.	Device: Maxillary 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.; Other Names: Custom CAD/CAM subperiosteal implant overdenture
Experimental: Group 2: 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	Device: Maxillary 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prosthetic Complications	Aesthetic -mechanical -functional and biological categories	Baseline (immediately following prosthesis placement) and after one year
Patient satisfaction	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	Baseline (immediately following prosthesis placement) and after one year

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Subperiosteal Implant; Milled Bar
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Jaw Diseases; Tooth Diseases; Mouth, Edentulous; Jaw, Edentulous
• Other Study ID Numbers: MDP.25.04.12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No