Clinical Trial

Comparison of Conventional and 3D-printed Surgical Obturators for Maxillary Defects

Recruiting
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Record status
This record was last updated July 24, 2025 (before its estimated November 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
This randomized controlled clinical trial aims to compare patient satisfaction and prosthetic complications associated with three types of immediate surgical obturators used in maxillectomy patients. A total of 24 patients with acquired maxillary defects will be randomly assigned to receive one of three obturator designs: (1) conventional obturators retained with clasps and wire, (2) resin 3D-printed obturators with printed clasps and palatal screws, or (3) metallic 3D-printed obturators with metal clasps and palatal screws. Patient satisfaction will be evaluated using the Obturator Functioning Scale (OFS), and postoperative complications such as discomfort, lack of retention, or mucosal irritation . The study seeks to determine whether digital fabrication and enhanced retention methods improve clinical outcomes compared to traditional approaches
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-13.
Trial Details
NCT Number NCT07079163
Lead Sponsor Fatma mahanna
Conditions Maxillary Defect Reconstruction
Enrollment 24 participants
Start Date 2025-01-25
Primary Completion 2025-11-30 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-07-24