Actively Recruiting

Phase Not Applicable
Age: 36Years - 68Years
All Genders
NCT07079163

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

Led by Fatma mahanna · Updated on 2025-07-24

24

Participants Needed

1

Research Sites

48 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 36Years - 68Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients indicated for maxillectomy with the remaining number of teeth
  • Referral to Maxillofacial Prosthodontic Unit, Mansoura University
Not Eligible

You will not qualify if you...

  • Contraindication to surgery (not physically fit to undergo surgery)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Maxillofacial Prosthodontic Unit, Faculty of Dentistry, Mansoura University

Al Mansurah, Egypt, 35511

Actively Recruiting

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Research Team

F

Fatma F Mahanaa, phD

CONTACT

A

Alaa Zaki

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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