Conventional One-piece Versus Two-piece Magnet-retained Obturators (obturators)

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

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

Study Overview

• Status: Completed
• Conditions: Patient Satisfaction
• Intervention / Treatment: Other: two pieces obturator

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).

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11511
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional obturator; Participants received conventional obturator one piece	Other: two pieces obturator; patient received two pieces obturator connecting by magnet attachment; Other Names: sectional obturator
Experimental: sectional obturator; two pieces obturators connected by magnet attachments	Other: two pieces obturator; patient received two pieces obturator connecting by magnet attachment; Other Names: sectional obturator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction	evaluation of satisfaction by Obturator Functioning Scale(OFS)	1 week to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction	evaluation of satisfaction by Oral Health Impact Profile for edentulous people (OHIP-EDENT )	1 week to 6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): January 30, 2021

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): October 4, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 214/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No