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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04778254
Other study ID # 38/10/2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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