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Clinical Trials/NCT04778254
NCT04778254CompletedNot Applicable

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

Cairo University2 sites in 1 country18 target enrollmentStarted: February 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sharaf Mohamed Yahia

Principal Investigator,

Cairo University

Study Sites (2)

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