PEEK Versus Metallic Attachment-retained Obturators

Not Applicable

Completed

• Conditions: Maxillary Neoplasms
• Interventions: Other: conventional obturator; Other: metalic attachment retained obturator; Other: PEEK attachment retained obturator

• Registration Number: NCT04778254
• Lead Sponsor: Cairo University

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 Timeline

• Study Start: 2018-02-01
• Primary Completion: 2019-07-01
• Study Completion: 2019-08-30
• Status Verified: 2021-02
• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-02-26
• Last Update Submitted: 2021-02-26
• Study First Posted: 2021-03-03
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional obturator	conventional obturator	conventional group received conventional clasp-retained obturators with metallic framework (Control group).
metallic attachment retained obturator	metalic attachment retained obturator	metal group received an attachment-retained obturator with metallic framework
PEEk attachment retained obturator	PEEK attachment retained obturator	PEEK group received attachment-retained obturators with milled PEEK framework,

Primary Outcome Measures

Name	Time	Method
patient satisfaction 1(change" is being assessed)	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)	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 Outcome Measures

Name	Time	Method
Radiographic evaluation (change" is being assessed)	base line,6 months, 9 months,12 months	evaluation of terminal abutment

Trial Locations

Locations (1)

Mohamed Sharaf; 🇪🇬 Cairo, Egypt