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

NCT07079163 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-07-24

No results posted yet for this study

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

Conditions

  • Maxillary Defect Reconstruction

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.

Sponsors & Collaborators

  • Fatma mahanna

    lead OTHER

Principal Investigators

  • fatma mahanna, Phd · Mansoura university, faculty of dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
36 Years
Max Age
68 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-25
Primary Completion
2025-11-30
Completion
2025-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07079163 on ClinicalTrials.gov