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Clinical Trials/NCT05066828
NCT05066828
Completed
Not Applicable

Patient Satisfaction of Conventional One-piece Versus Two-piece Magnet-retained Obturators for Patients With Complete Edentulism: A Crossover Study

Cairo University1 site in 1 country10 target enrollmentMarch 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patient Satisfaction
Sponsor
Cairo University
Enrollment
10
Locations
1
Primary Endpoint
patient satisfaction
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Evaluation of patients' satisfaction with conventional one-piece obturators versus two pieces magnet -retained obturators in completely edentulous patient maxillectomy cases.

Detailed Description

Ten completely edentulous participants with hemimaxillectomy (8 males and 2 females) were selected in an across over study. Participants received conventional obturator one piece and two pieces obturator connecting by magnet attachment in alternate periods (sequences A-B and B-A), and outcomes were assessed after 1 week,3 months, and 6 months Evaluation included Obturator Functioning Scale(OFS) and Oral Health Impact Profile for edentulous people (OHIP-EDENT ). One way ANOVA test and Multivariate analysis of variance with a general linear model with repeated measure was used to test the impact of the group, time, and order on each of the studied scores (α=.05).

Registry
clinicaltrials.gov
Start Date
March 1, 2018
End Date
January 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sharaf Mohamed Yahia

lecturer

Cairo University

Eligibility Criteria

Inclusion Criteria

  • completely edentulous participants with hemimaxillectomy mouth opening is not less than 25 mm and intact soft palate

Exclusion Criteria

  • exposed to radiotherpy

Outcomes

Primary Outcomes

patient satisfaction

Time Frame: 1 week to 6 months

evaluation of satisfaction by Obturator Functioning Scale(OFS)

Secondary Outcomes

  • patient satisfaction(1 week to 6 months)

Study Sites (1)

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