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Completed

NCT Number: NCT05066828

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

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

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Key information

Conditions

Patient Satisfaction Behavior Health Behavior Treatment Adherence and Compliance

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 11511, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • exposed to radiotherpy

Treatment and study plan

two pieces obturator

Other

patient received two pieces obturator connecting by magnet attachment

Other names: sectional obturator

Primary outcomes

  1. patient satisfaction

    Time frame: 1 week to 6 months

    evaluation of satisfaction by Obturator Functioning Scale(OFS)

Secondary outcomes

  1. patient satisfaction

    Time frame: 1 week to 6 months

    evaluation of satisfaction by Oral Health Impact Profile for edentulous people (OHIP-EDENT )

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: obturators

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Oct 4, 2021
Registry last updated
Oct 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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