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CompletedNCT04778254PEEKUpdated Mar 3, 2021

PEEK Versus Metallic Attachment-retained Obturators

An interventional study of PEEK attachment retained obturator and metalic attachment retained obturator in Maxillary Neoplasms, sponsored by Cairo University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2021-03-03.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years after the study started (first participant enrolled Feb 2018, registered Feb 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Maxillary Neoplasms
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Exclusion Criteria:

  • participants are exposed to radiotherapy or chemotherapy during last year.
  • participant with congenital defect
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
18 participants (actual)

Study arms

  • Active comparator
    conventional obturator

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

    Other: conventional obturator

  • Experimental
    metallic attachment retained obturator

    metal group received an attachment-retained obturator with metallic framework

    Other: metalic attachment retained obturator

  • Experimental
    PEEk attachment retained obturator

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

    Other: PEEK attachment retained obturator

Interventions

  • OtherPEEK attachment retained obturator

    attachment retained obturator for management of hemi maxillectomy

    Also known as: milled PEEK obturator

  • Othermetalic attachment retained obturator

    attachment retained obturator for management of hemi maxillectomy

    Also known as: attachment retained obturator

  • Otherconventional obturator

    clasp retained obturator for management of hemi maxillectomy

    Also known as: clasp retained obturator

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What researchers measure

Primary outcomes

  1. patient satisfaction 1(change" is being assessed)

    The Obturator Functioning Scale ( minimum value is "1"and maximum value is "5"

    Time frame: 1 week to 6 months

  2. patient satisfaction 2 (change" is being assessed)

    The European Organization for Research and Treatment of Cancer Head and Neck 35 ( minimum value is "1"and maximum value is "5"

    Time frame: 1 week to 6 months

Secondary outcomes

  1. Radiographic evaluation (change" is being assessed)

    evaluation of terminal abutment

    Time frame: base line,6 months, 9 months,12 months

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Study locations

1 site
  • Mohamed Sharaf
    Cairo, 11625, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided — finished work will be published

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04778254
Lead sponsor
Cairo University
Responsible party
Sharaf Mohamed Yahia (Principal Investigator,, Cairo University) — Principal investigator
First posted
Mar 3, 2021
Start date
Feb 1, 2018
Primary completion
Jul 1, 2019
Completion
Aug 30, 2019
Last update
Mar 3, 2021

Study contacts

Mohamed Sharaf, lecturer
principal investigator · Beni-Suef University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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