Conventional One-piece Versus Two-piece Magnet-retained O... | NCT05066828

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

NCT05066828

Sponsor

Cairo University

Status

Completed

Last Update Posted

Oct 4, 2021Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Patient Satisfaction

Interventions

two pieces obturator

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2018Actual

Primary Completion Date

Nov 30, 2020Actual

Completion Date

Jan 30, 2021Actual

First Submitted Date

Jul 5, 2021

First Submission Date that Met QC Criteria

Sep 22, 2021

First Posted Date

Oct 4, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2021

Last Update Posted Date

Oct 4, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
conventional obturator	Active Comparator	Participants received conventional obturator one piece	Other: two pieces obturator
sectional obturator	Experimental	two pieces obturators connected by magnet attachments	Other: two pieces obturator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
two pieces obturator	Other	patient received two pieces obturator connecting by magnet attachment	conventional obturator sectional obturator

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Cairo University		Cairo		11511	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017060	Patient Satisfaction

Ancestor Terms

ID	Term
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided