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Completed

NCT Number: NCT04778254

PEEK Versus Metallic Attachment-retained Obturators

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.

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Key information

Conditions

Maxillary Neoplasms Bone Diseases Bone Neoplasms Jaw Diseases Jaw Neoplasms Maxillary Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Skull Neoplasms Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohamed Sharaf

Cairo, 11625, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEEK attachment retained obturator

Other

attachment retained obturator for management of hemi maxillectomy

Other names: milled PEEK obturator

metalic attachment retained obturator

Other

attachment retained obturator for management of hemi maxillectomy

Other names: attachment retained obturator

conventional obturator

Other

clasp retained obturator for management of hemi maxillectomy

Other names: clasp retained obturator

Primary outcomes

  1. 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"

  2. 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

  1. Radiographic evaluation (change" is being assessed)

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

    evaluation of terminal abutment

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: PEEK

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 3, 2021
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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