PEEK Versus Metallic Attachment-retained Obturators

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2019-08-30

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.

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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.

Conditions

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Maxillary Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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conventional obturator

conventional group received conventional clasp-retained obturators with metallic framework (Control group).

Group Type ACTIVE_COMPARATOR

conventional obturator

Intervention Type OTHER

clasp retained obturator for management of hemi maxillectomy

metallic attachment retained obturator

metal group received an attachment-retained obturator with metallic framework

Group Type EXPERIMENTAL

metalic attachment retained obturator

Intervention Type OTHER

attachment retained obturator for management of hemi maxillectomy

PEEk attachment retained obturator

PEEK group received attachment-retained obturators with milled PEEK framework,

Group Type EXPERIMENTAL

PEEK attachment retained obturator

Intervention Type OTHER

attachment retained obturator for management of hemi maxillectomy

Interventions

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PEEK attachment retained obturator

attachment retained obturator for management of hemi maxillectomy

Intervention Type OTHER

metalic attachment retained obturator

attachment retained obturator for management of hemi maxillectomy

Intervention Type OTHER

conventional obturator

clasp retained obturator for management of hemi maxillectomy

Intervention Type OTHER

Other Intervention Names

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milled PEEK obturator attachment retained obturator clasp retained obturator

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,