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PEEK Versus Metallic Attachment-retained Obturators

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04778254
Collaborator
(none)
18
Enrollment
1
Location
3
Arms
18.9
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: PEEK attachment retained obturator
  • Other: metalic attachment retained obturator
  • Other: conventional obturator
 N/A

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
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
PEEK Versus Metallic Attachment-retained Obturators Regarding Patient Satisfaction: A Randomized Controlled Trial.
Actual Study Start Date :
Feb 1, 2018
Actual Primary Completion Date :
Jul 1, 2019
Actual Study Completion Date :
Aug 30, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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"

    2. 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

    1. Radiographic evaluation (change" is being assessed) [base line,6 months, 9 months,12 months]

      evaluation of terminal abutment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mohamed Sharaf Cairo Egypt 11625

    Sponsors and Collaborators

    • Cairo University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sharaf Mohamed Yahia, Principal Investigator,, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04778254
    Other Study ID Numbers:
    • 38/10/2018
    First Posted:
    Mar 3, 2021
    Last Update Posted:
    Mar 3, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Maxillary Neoplasms

    Study Results

    No Results Posted as of Mar 3, 2021