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

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-04

Study Completion Date

2024-08-04

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Patient Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type OTHER

Obturator

Intervention Type OTHER

Evaluation of patient satisfaction and oral healthy related quality of life of Polyetherketoneketone(PEKK) and metal framework for management of maxillectomy cases.

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.

Group Type OTHER

Obturator

Intervention Type OTHER

Evaluation of patient satisfaction and oral healthy related quality of life of Polyetherketoneketone(PEKK) and metal framework for management of maxillectomy cases.

Interventions

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Obturator

Evaluation of patient satisfaction and oral healthy related quality of life of Polyetherketoneketone(PEKK) and metal framework for management of maxillectomy cases.

Intervention Type OTHER

Eligibility Criteria

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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.