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Comparison of Conventional and 3D-printed Surgical Obturators for Maxillary Defects
Sponsor: Fatma mahanna
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
Official title: Comparison of Patient Satisfaction and Prosthetic Complications Between Conventional Immediate Surgical Obturators and 3D-printed Immediate Surgical Obturators With Enhanced Retention
Key Details
Gender
All
Age Range
36 Years - 68 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2025-01-25
Completion Date
2025-12-31
Last Updated
2025-07-24
Healthy Volunteers
No
Conditions
Interventions
Obturator block
A manually fabricated obturator using a preoperative maxillary cast, retained with clasps and wire. Delivered immediately after maxillectomy.
Obturator block
A digitally designed obturator based on fused CBCT and intraoral scan data. Fabricated in resin using 3D-printing, and retained with 3D-printed clasps and palatal screws. Delivered immediately post-maxillectomy
Obturator block
A digitally designed and 3D-printed obturator fabricated in metal, using CBCT and intraoral scan data. Retention is provided by metal clasps and palatal screws. Delivered during or immediately after surgery.
Locations (1)
Maxillofacial Prosthodontic Unit, Faculty of Dentistry, Mansoura University
Al Mansurah, Egypt