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NCT05066828 Clinical Trial

Conventional One-piece Versus Two-piece Magnet-retained Obturators

Patient Satisfaction Clinical Trial

— obturators  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05066828
Other study ID # 214/2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date January 30, 2021

Study information
Verified date September 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date January 30, 2021
Est. primary completion date November 30, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - completely edentulous participants with hemimaxillectomy mouth opening is not less than 25 mm and intact soft palate Exclusion Criteria: - exposed to radiotherpy

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• two pieces obturator
patient received two pieces obturator connecting by magnet attachment

Locations
Country Name City State
Egypt Cairo University 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 evaluation of satisfaction by Obturator Functioning Scale(OFS) 1 week to 6 months
Secondary patient satisfaction evaluation of satisfaction by Oral Health Impact Profile for edentulous people (OHIP-EDENT ) 1 week to 6 months
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