PEEK Versus Metallic Attachment-retained Obturators (PEEK)

February 26, 2021 updated by: Sharaf Mohamed Yahia, Cairo University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11625
        • Mohamed Sharaf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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"
1 week to 6 months
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"
1 week to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Mohamed Sharaf, lecturer, Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

August 30, 2019

Study Registration Dates

First Submitted

February 22, 2021

First Submitted That Met QC Criteria

February 26, 2021

First Posted (Actual)

March 3, 2021

Study Record Updates

Last Update Posted (Actual)

March 3, 2021

Last Update Submitted That Met QC Criteria

February 26, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38/10/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

finished work will be published

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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