Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07079163
NA

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

Sponsor: Fatma mahanna

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

Maxillofacial Prosthodontic Unit, Faculty of Dentistry, Mansoura University

Al Mansurah, Egypt