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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06070727
Enrollment
20
Registered
2023-10-06
Start date
2023-07-04
Completion date
2024-08-04
Last updated
2023-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Satisfaction

Keywords

Polyetherketoneketone, Metal, Obturator

Brief summary

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

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.

Interventions

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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Patient satisfaction6 monthsObturator 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026