PEEK Versus Metallic Attachment-retained Obturators

Maxillary Neoplasms Clinical Trial

— PEEK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04778254
• Other study ID #: 38/10/2018
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: February 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 30, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Maxillary Neoplasms

Intervention

Other:
• PEEK attachment retained obturator
attachment retained obturator for management of hemi maxillectomy
• metalic attachment retained obturator
attachment retained obturator for management of hemi maxillectomy
• conventional obturator
clasp retained obturator for management of hemi maxillectomy

Locations

Country	Name	City	State
Egypt	Mohamed Sharaf	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient satisfaction 1(change" is being assessed)	The Obturator Functioning Scale ( minimum value is "1"and maximum value is "5"	1 week to 6 months
Primary	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"	1 week to 6 months
Secondary	Radiographic evaluation (change" is being assessed)	evaluation of terminal abutment	base line,6 months, 9 months,12 months