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
1 other identifier
interventional
20
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 4, 2023
CompletedFirst Submitted
Initial submission to the registry
September 20, 2023
CompletedFirst Posted
Study publicly available on registry
October 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 4, 2024
CompletedOctober 6, 2023
July 1, 2023
1 year
September 20, 2023
October 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Metal framework group
OTHERgroup 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.
PEKK framework group
OTHERGroup B: Patients will receive PEKK obturator for 6 months, then the same patients will receive metallic framework obturator for another 6 months.
Interventions
Evaluation of patient satisfaction and oral healthy related quality of life of Polyetherketoneketone(PEKK) and metal framework for management of maxillectomy cases.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patient is still receiving radiation.
- Defect result from trauma.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mohammed ELSawy
Al Mansurah, 12345, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2023
First Posted
October 6, 2023
Study Start
July 4, 2023
Primary Completion
July 4, 2024
Study Completion
August 4, 2024
Last Updated
October 6, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share