Polyetherketoneketone and Metal Framework for Management of Maxillectomy Cases: Across Over Study

Patient Satisfaction and Oral Healthy Related Quality of Life of Polyetherketoneketone and Metal Framework for Management of Maxillectomy Cases: Across Over Study

Prosthetic rehabilitation of acquired maxillary defects represents a challenging mission for both the prosthodontist and psychologically traumatized patients. These defects may be due to trauma, pathological conditions, or surgical resection of oral tumors. The resulting main problem is oronasal communication leading to impairment in mastication, swallowing, speech, and facial esthetics

Study Overview

• Status: Active, not recruiting
• Conditions: Patient Satisfaction
• Intervention / Treatment: Other: Obturator

Detailed Description

Maxillary obturator prostheses are usually fabricated from polymethyl methacrylate (PMMA) if the patient is completely edentulous, or from PMMA and a cast frame-work if partially edentulous. As the size of the surgical resection increases, the weight of the prosthesis also increases. Traditionally, the weight of the prosthesis has been minimized through the use of hollow bulb obturators and change of manufacturing material.

Polyetherketoneketone (PEKK) has been widely tested in a number of dental applications, such as PEKK dental implants, PEKK obturators, and PEEK RPD frameworks. PEKK has a relatively low Young's modulus of 3 to 4 GPa, which is close to that of human bones, and its tensile properties are similar to those of bone, enamel, and dentin. These properties make it a suitable material for fixed and removable prostheses.(6-8) PEKK is a lightweight material with excellent biocompatibility as it can be used in combination with Computer-aided design/computer-assisted manufacturing (CAD/CAM) in fabrication of maxillofacial prostheses.(9) So the aim of this study will be, evaluation of Patient satisfaction and oral healthy related quality of life of PEKK and metal framework for management of maxillectomy cases. The null hypothesis is that, there would be no significant difference between both frameworks.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt, 12345
    • Mohammed Elsawy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

The patient will be selected according to the following criteria:

• Patient with unilateral total maxillectomy.
• Patients will have sufficient number of remaining teeth.
• Free from any signs of inflammation in defect area.
• Patient 3 years after receiving radiation.
• The defect size is small or large.
• Patient with susceptibility of recurrence.

Exclusion Criteria:

• Patient is still receiving radiation.
• Defect result from trauma.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Metal framework group; group A: Patients will receive metallic framework with obturator for 6 months, then the metallic obturator will be replaced by PEKK obturator for another 6 months.	Other: Obturator; Evaluation of patient satisfaction and oral healthy related quality of life of Polyetherketoneketone(PEKK) and metal framework for management of maxillectomy cases.
Other: PEKK framework group; Group B: Patients will receive PEKK obturator for 6 months, then the same patients will receive metallic framework obturator for another 6 months.	Other: Obturator; Evaluation of patient satisfaction and oral healthy related quality of life of Polyetherketoneketone(PEKK) and metal framework for management of maxillectomy cases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Obturator functioning scale (OFS) used for evaluation of patient satisfaction, such as improvement in speech, better swallowing with the obturator, feeling and appearance of the upper lip, general feeling in the mouth, self confidence, and avoidance of social family events	6 months

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2023
• Primary Completion (Estimated): July 4, 2024
• Study Completion (Estimated): August 4, 2024

Study Registration Dates

• First Submitted: September 20, 2023
• First Submitted That Met QC Criteria: October 1, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 1, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Polyetherketoneketone, Metal, Obturator
• Other Study ID Numbers: M0107023RP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No