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

NCT07079163 | Recruiting

• 1 other identifier: A04011024RP
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Maxillary defects; Immediate surgical obturator; patient-centered outcomes; Digital; 3D-printed

Outcome Measures

Primary Outcomes (1)

• patient satisfaction

  Patient satisfaction: measured by Obturator Functioning Scale (OFS) over 2-3 weeks.The Obturator Functioning Scale (OFS) is a patient-reported outcome measure developed to assess the functional performance and satisfaction with an obturator prosthesis, particularly in maxillectomy patients. It evaluates multiple domains related to oral rehabilitation.The OFS typically includes items addressing the following: Appearance (Esthetics) Speech Intelligibility Swallowing (Deglutition) Chewing/Mastication Comfort Retention and Stability Overall Satisfaction 5-point Likert scale (e.g., 1 = very poor, 5 = excellent

  2-3 weeks after surgery

Secondary Outcomes (1)

• complications

  2-3 weeks after surgery

Study Arms (3)

Conventional Immediate Obturator Group/ obturator block

EXPERIMENTAL

Participants will receive a conventional immediate surgical obturator fabricated manually on a preoperative cast. Retention will be provided using clasps and/or wiring. The obturator will be inserted immediately after maxillectomy and used during the healing period.

Device: Obturator block

Resin 3D-Printed Obturator Group

EXPERIMENTAL

Participants will receive a resin 3D-printed immediate surgical obturator, digitally designed using intraoral scans and CBCT data. Retention will be achieved using 3D-printed clasps and palatal screws. The obturator will be inserted immediately after surgery and monitored during healing.

Device: Obturator block

Metallic 3D-Printed Obturator Group

EXPERIMENTAL

Participants will receive a metallic 3D-printed immediate surgical obturator, digitally designed using fused CBCT and digital impressions. The prosthesis will include metal clasps and palatal screws for enhanced retention. It will be delivered at surgery and assessed over the healing period.

Device: Obturator block

Interventions

Obturator block DEVICE

A manually fabricated obturator using a preoperative maxillary cast, retained with clasps and wire. Delivered immediately after maxillectomy.

Also known as: Conventional Immediate Obturator Group

Conventional Immediate Obturator Group/ obturator block

Eligibility Criteria

• Age: 36 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients indicated for maxillectomy with the remaining number of teeth
• Referral to Maxillofacial Prosthodontic Unit, Mansoura University

You may not qualify if:

• contraindication to surgery (not physically fit to underwent surgery)

Sponsors & Collaborators

• Fatma mahanna: lead

Study Sites (1)

Maxillofacial Prosthodontic Unit, Faculty of Dentistry, Mansoura University

Al Mansurah, 35511, Egypt

RECRUITING

Study Officials

• fatma mahanna, Phd

  Mansoura university, faculty of dentistry

  STUDY CHAIR

Central Study Contacts

Fatma F Mahanaa, phD

CONTACT

+201006863040; fatmamahanna@mans.edu.eg

Alaa Zaki

CONTACT

+201069703419

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor of prosthodontics

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: July 22, 2025
• Study Start: January 25, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

EG (1)