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

NCT07632885 | Active Not Recruiting DMC

• 1 other identifier: MDP.25.04.12
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Jaw Edentulous

Keywords

Subperiosteal Implant; Milled Bar

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group 1: Milled Bar-Retained Prosthesis

EXPERIMENTAL

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

Group 2: Screw-Retained Prosthesis

EXPERIMENTAL

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

Interventions

Maxillary subperiosteal implant with milled bar-retained prosthesis DEVICE

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.

Also known as: Custom CAD/CAM subperiosteal implant overdenture

Group 1: Milled Bar-Retained Prosthesis

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.

Group 2: Screw-Retained Prosthesis

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry of Mansoura University

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly allocated into two parallel groups to receive either a milled bar-retained prosthesis or a screw-retained prosthesis

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 8, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

EG (1)