Back to resultsPEEK Versus Metallic Attachment-retained Obturators (PEEK)
Primary Purpose
Maxillary Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PEEK attachment retained obturator
metalic attachment retained obturator
conventional obturator
Sponsored by
About this trial
This is an interventional treatment trial for Maxillary Neoplasms
Eligibility Criteria
Inclusion Criteria:
- patient underwent surgical removal of half of maxilla
- participants with a sufficient number of natural teeth(class I and \or class IV Aramany classification) not less than 5 teeth, mouth opening is not less than 25 mm, intact soft palate,
Exclusion Criteria:
- participants are exposed to radiotherapy or chemotherapy during last year.
- participant with congenital defect
Sites / Locations
- Mohamed Sharaf
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
conventional obturator
metallic attachment retained obturator
PEEk attachment retained obturator
Arm Description
conventional group received conventional clasp-retained obturators with metallic framework (Control group).
metal group received an attachment-retained obturator with metallic framework
PEEK group received attachment-retained obturators with milled PEEK framework,
Outcomes
Primary Outcome Measures
patient satisfaction 1(change" is being assessed)
The Obturator Functioning Scale ( minimum value is "1"and maximum value is "5"
patient satisfaction 2 (change" is being assessed)
The European Organization for Research and Treatment of Cancer Head and Neck 35 ( minimum value is "1"and maximum value is "5"
Secondary Outcome Measures
Radiographic evaluation (change" is being assessed)
evaluation of terminal abutment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04778254
Brief Title
PEEK Versus Metallic Attachment-retained Obturators
Acronym
PEEK
Official Title
PEEK Versus Metallic Attachment-retained Obturators Regarding Patient Satisfaction: A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Patients' satisfaction evaluation and radiographic evaluation of the terminal abutments of attachment- retained maxillary obturators with metal framework versus milled PEEK framework in the management of maxillectomy cases.
Detailed Description
Eighteen participants were randomly divided into three parallel groups (n=6). Participants of PEEK group received attachment-retained obturators with milled PEEK framework, metal group received an attachment-retained obturator with metallic framework and conventional group received conventional clasp-retained obturators with metallic framework (Control group). Evaluation included radiographic evaluation and patients' satisfaction where two scales were followed in this study, including "The Obturator Functioning Scale" and "The European Organization for Research and Treatment of Cancer Head and Neck 35" using one way ANOVA test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maxillary Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conventional obturator
Arm Type
Active Comparator
Arm Description
conventional group received conventional clasp-retained obturators with metallic framework (Control group).
Arm Title
metallic attachment retained obturator
Arm Type
Experimental
Arm Description
metal group received an attachment-retained obturator with metallic framework
Arm Title
PEEk attachment retained obturator
Arm Type
Experimental
Arm Description
PEEK group received attachment-retained obturators with milled PEEK framework,
Intervention Type
Other
Intervention Name(s)
PEEK attachment retained obturator
Other Intervention Name(s)
milled PEEK obturator
Intervention Description
attachment retained obturator for management of hemi maxillectomy
Intervention Type
Other
Intervention Name(s)
metalic attachment retained obturator
Other Intervention Name(s)
attachment retained obturator
Intervention Description
attachment retained obturator for management of hemi maxillectomy
Intervention Type
Other
Intervention Name(s)
conventional obturator
Other Intervention Name(s)
clasp retained obturator
Intervention Description
clasp retained obturator for management of hemi maxillectomy
Primary Outcome Measure Information:
Title
patient satisfaction 1(change" is being assessed)
Description
The Obturator Functioning Scale ( minimum value is "1"and maximum value is "5"
Time Frame
1 week to 6 months
Title
patient satisfaction 2 (change" is being assessed)
Description
The European Organization for Research and Treatment of Cancer Head and Neck 35 ( minimum value is "1"and maximum value is "5"
Time Frame
1 week to 6 months
Secondary Outcome Measure Information:
Title
Radiographic evaluation (change" is being assessed)
Description
evaluation of terminal abutment
Time Frame
base line,6 months, 9 months,12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient underwent surgical removal of half of maxilla
participants with a sufficient number of natural teeth(class I and \or class IV Aramany classification) not less than 5 teeth, mouth opening is not less than 25 mm, intact soft palate,
Exclusion Criteria:
participants are exposed to radiotherapy or chemotherapy during last year.
participant with congenital defect
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Sharaf, lecturer
Organizational Affiliation
Beni-Suef University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mohamed Sharaf
City
Cairo
ZIP/Postal Code
11625
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
finished work will be published
Learn more about this trial
PEEK Versus Metallic Attachment-retained Obturators
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