PEEK Versus Metallic Attachment-retained Obturators

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04778254

Acronym

PEEK

Enrollment

Registered

2021-03-03

Start date

2018-02-01

Completion date

2019-08-30

Last updated

2021-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary Neoplasms

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.

Interventions

OTHERPEEK attachment retained obturator

attachment retained obturator for management of hemi maxillectomy

OTHERmetalic attachment retained obturator

attachment retained obturator for management of hemi maxillectomy

OTHERconventional obturator

clasp retained obturator for management of hemi maxillectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
patient satisfaction 1(change is being assessed)	1 week to 6 months	The Obturator Functioning Scale ( minimum value is 1and maximum value is 5
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 1and maximum value is 5

Secondary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026