PEEK Versus Metallic Attachment-retained Obturators Regarding Patient Satisfaction: A Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- patient satisfaction 1(change" is being assessed)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
patient satisfaction 1(change" is being assessed)
Time Frame: 1 week to 6 months
The Obturator Functioning Scale ( minimum value is "1"and maximum value is "5"
patient satisfaction 2 (change" is being assessed)
Time Frame: 1 week to 6 months
The European Organization for Research and Treatment of Cancer Head and Neck 35 ( minimum value is "1"and maximum value is "5"
Secondary Outcomes
- Radiographic evaluation (change" is being assessed)(base line,6 months, 9 months,12 months)
Investigators
Sharaf Mohamed Yahia
Principal Investigator,
Cairo University