PEEK Versus Metallic Attachment-retained Obturators

Study Overview
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Brief Summary
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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
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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.

Official Title
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PEEK Versus Metallic Attachment-retained Obturators Regarding Patient Satisfaction: A Randomized Controlled Trial.

Conditions
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Maxillary Neoplasms

Intervention / Treatment
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* Other: PEEK attachment retained obturator
* Other: metalic attachment retained obturator
* Other: conventional obturator


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional obturator<br>conventional group received conventional clasp-retained obturators with metallic framework (Control group). | Other: conventional obturator<br>* clasp retained obturator for management of hemi maxillectomy<br>* Other names: clasp retained obturator;|
| Experimental: metallic attachment retained obturator<br>metal group received an attachment-retained obturator with metallic framework | Other: metalic attachment retained obturator<br>* attachment retained obturator for management of hemi maxillectomy<br>* Other names: attachment retained obturator;|
| Experimental: PEEk attachment retained obturator<br>PEEK group received attachment-retained obturators with milled PEEK framework, | Other: PEEK attachment retained obturator<br>* attachment retained obturator for management of hemi maxillectomy<br>* Other names: milled PEEK obturator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction 1(change is being assessed) | The Obturator Functioning Scale ( minimum value is 1and maximum value is 5 | 1 week to 6 months | 
| patient satisfaction 2 (change is being assessed) | The European Organization for Research and Treatment of Cancer Head and Neck 35 ( minimum value is 1and maximum value is 5 | 1 week to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic evaluation (change is being assessed) | evaluation of terminal abutment | base line,6 months, 9 months,12 months |