Comparison of Conventional and 3D-printed Surgical Obturators for Maxillary Defects
NCT ID: NCT07079163
Last Updated: 2025-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
24 participants
INTERVENTIONAL
2025-01-25
2025-12-31
Brief Summary
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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
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Conventional Immediate Obturator Group/ obturator block
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.
Obturator block
A manually fabricated obturator using a preoperative maxillary cast, retained with clasps and wire. Delivered immediately after maxillectomy.
Resin 3D-Printed Obturator Group
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.
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
Metallic 3D-Printed Obturator Group
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.
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.
Interventions
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Obturator block
A manually fabricated obturator using a preoperative maxillary cast, retained with clasps and wire. Delivered immediately after maxillectomy.
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Referral to Maxillofacial Prosthodontic Unit, Mansoura University
Exclusion Criteria
36 Years
68 Years
ALL
No
Sponsors
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Fatma mahanna
OTHER
Responsible Party
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Fatma mahanna
Assistant professor of prosthodontics
Principal Investigators
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fatma mahanna, Phd
Role: STUDY_CHAIR
Mansoura university, faculty of dentistry
Locations
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Maxillofacial Prosthodontic Unit, Faculty of Dentistry, Mansoura University
Al Mansurah, , Egypt
Countries
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Central Contacts
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Alaa Zaki
Role: CONTACT
Facility Contacts
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Other Identifiers
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A04011024RP
Identifier Type: -
Identifier Source: org_study_id
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