Accuracy of Maxillary Obturator Bulb in Maxillectomy Defects

NCT06403930 | Completed

• 1 other identifier: 2024-1
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment of tumors in the paranasal region often requires maxillectomy procedures. While surgical reconstruction is preferred, prosthetic reconstruction using obturators becomes necessary when surgery is not feasible. Obturators separate oral and nasal cavities, restoring functions like chewing, speech, and facial aesthetics, while alleviating psychological distress. The emergence of rapid prototyping (RP) technologies since 1995 has revolutionized prosthetic construction. RP techniques like stereolithography and 3D printing enable layer-by-layer production of accurate 3D models from computer designs. Combined with imaging like CT and MRI, RP allows creation of highly precise extraoral facial prostheses. For intraoral defects, integrating 3D CAD and RP can enhance prosthetic outcomes compared to conventional gypsum models, although obtaining accurate impressions remains challenging due to factors like defect size, undercuts, and mucosal issues.

Conditions

Maxillary Obturators

Outcome Measures

Primary Outcomes (1)

• Root mean square

  Serial 3D dental model superimposition allows for a detailed, risk-free evaluation of morphological changes in a patient's mouth over time. In this study, the accuracy and precision of five different palatal areas used for superimposing maxillary 3D digital dental casts were evaluated.

  10 days

Study Arms (2)

Group I

ACTIVE COMPARATOR

PMMA bulbs on metal frameworks

Device: Maxillary Obturator

Group II

EXPERIMENTAL

Injection-molded PMMA obturators.

Device: Maxillary Obturator

Interventions

Maxillary Obturator DEVICE

Maxillary obturators are prosthetic devices used to close maxillary defects resulting from surgical removal of part or all of the maxilla bone due to conditions like tumors or congenital anomalies. They separate the oral and nasal cavities, restore speech, swallowing, and mastication functions, provide facial support, and improve aesthetics and quality of life.

Group I; Group II

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The study enrolled participants of all genders who had defects or abnormalities involving both hard and soft palate regions.
• Participants were included if their surgical site was fully healed and they had partial tooth loss or missing teeth in the maxilla defect area.
• Only cooperative patients capable of following instructions were selected.

You may not qualify if:

• Individuals with temporomandibular disorders.
• uncontrolled diabetes.
• bleeding disorders.
• ongoing anticoagulant therapy.
• Patients with flabby tissues.
• sharp mandibular residual ridges.
• heavy smoking habits.
• neuromuscular disorders.
• severe psychiatric conditions were also not eligible for the study.
• The study did not include children, with only adult participants considered.

Sponsors & Collaborators

• Badr University: lead

Study Sites (1)

Faculty of oral and dental medicine

Cairo, 31645, Egypt

Location

Study Officials

• Shady Elnaggar

  Badr university in Cairo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: This study evaluated the accuracy of different obturator materials using Bland-Altman analysis and assessed patient satisfaction with obturators in post-maxillectomy patients using the obturator functioning scale, addressing functional and aesthetic issues caused by maxillofacial tumor surgeries that impact patients' quality of life and social well-being.

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 8, 2024
• Study Start: May 15, 2024
• Primary Completion: May 16, 2024
• Study Completion: May 16, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)