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

Fatma mahanna

Status: Enrolling

Conditions: Maxillary Defect Reconstruction

Treatments: Device: Obturator block

Study type: Interventional

Funder types: Other

Identifiers

NCT07079163

A04011024RP

Details and patient eligibility

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

Full description

Maxillary defects resulting from maxillectomy procedures lead to significant impairments in speech, mastication, swallowing, and quality of life. Rehabilitation typically involves either surgical reconstruction or the use of a prosthetic obturator. Immediate surgical obturators (ISOs) are commonly used during or immediately after surgery to seal the oronasal communication and support healing. However, conventional obturators are often bulky, manually fabricated, and prone to poor retention due to tissue changes during early healing, leading to reduced patient satisfaction and increased complications.

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 36 to 68 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 3 patient groups

Conventional Immediate Obturator Group/ obturator block

Experimental group

Description:

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.

Treatment:

Device: Obturator block

Device: Obturator block

Device: Obturator block

Resin 3D-Printed Obturator Group

Experimental group

Description:

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.

Treatment:

Device: Obturator block

Device: Obturator block

Device: Obturator block

Metallic 3D-Printed Obturator Group

Experimental group

Description:

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.

Treatment:

Device: Obturator block

Device: Obturator block

Device: Obturator block