NCT07079163

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

Comparison of Patient Satisfaction and Prosthetic Complications Between Conventional Immediate Surgical Obturators and 3D-printed Immediate Surgical Obturators With Enhanced Retention

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Fatma mahanna · Academic / Other
• Sex: All
• Age: 36 Years – 68 Years
• Healthy volunteers: Not accepted

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

Detailed description

Maxillary defects resulting from maxillectomy procedures lead to significant impairments in speech, mastication, swallowing, and quality of life. Rehabilitation typically involves either surgical reconstruction or the use of a prosthetic obturator. Immediate surgical obturators (ISOs) are commonly used during or immediately after surgery to seal the oronasal communication and support healing. However, conventional obturators are often bulky, manually fabricated, and prone to poor retention due to tissue changes during early healing, leading to reduced patient satisfaction and increased complications. Recent advancements in digital technology, including intraoral scanning and cone beam computed tomography (CBCT), allow for the precise design and 3D printing of obturators customized to the anticipated defect. Enhanced retention strategies such as palatal screws and custom clasps may offer improved stability, function, and comfort compared to conventional designs. This randomized controlled clinical trial aims to evaluate and compare the clinical performance of three types of immediate surgical obturators in patients undergoing maxillectomy. A total of 24 patients with acquired maxillary defects and sufficient remaining dentition will be randomly assigned to one of three groups: Group I: Conventional obturators retained with clasps and wire Group II: Resin 3D-printed obturators with printed clasps and palatal screws Group III: Metallic 3D-printed obturators with metal clasps and palatal screws The study's primary outcome is patient satisfaction, assessed using the Obturator Functioning Scale (OFS), which evaluates prosthesis-related comfort, appearance, speech, and function. Secondary outcomes include postoperative prosthetic complications such as pain, ulceration, poor fit, or dislodgement. Assessments will be conducted during the standard healing period. This study will provide valuable insights into the impact of digital workflows and retention techniques on the functional performance and patient-centered outcomes of obturator prostheses following maxillectomy. Ethical approval has been obtained, and all participants will provide informed consent prior to inclusion.

Conditions

• Maxillary Defect Reconstruction

Interventions

Type	Name	Description
DEVICE	Obturator block	A manually fabricated obturator using a preoperative maxillary cast, retained with clasps and wire. Delivered immediately after maxillectomy.
DEVICE	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
DEVICE	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.

Timeline

• Start date: 2025-01-25
• Primary completion: 2025-11-30
• Completion: 2025-12-31
• First posted: 2025-07-22
• Last updated: 2025-07-24

Locations

1 site across 1 country: Egypt