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

ConditionMaxillary Defect Reconstruction

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age36-68

SponsorFatma mahanna

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients indicated for maxillectomy with the remaining number of teeth

Referral to Maxillofacial Prosthodontic Unit, Mansoura University

Disqualifiers

contraindication to surgery (not physically fit to underwent surgery)

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

24 Participants

are divided into 3 treatment groups

Group A: Conventional Immediate Obturator Group/ obturator blockExperimental treatment 1 intervention

Group B: Resin 3D-Printed Obturator GroupExperimental treatment 1 intervention

Group C: Metallic 3D-Printed Obturator GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

2-3 weeks after surgery

Secondary outcomes

complications

Postoperative complications: type and frequency (pain, discomfort, dislodgement, etc.)

Time frame

2-3 weeks after surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fatma mahanna

Lead sponsor

Mansoura University

Sponsor institution

Source ClinicalTrials.gov

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