NCT05066828

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
Last Updated

October 4, 2021

Status Verified

September 1, 2021

Enrollment Period

2.8 years

First QC Date

July 5, 2021

Last Update Submit

September 22, 2021

Conditions

Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

  • patient satisfaction

    evaluation of satisfaction by Obturator Functioning Scale(OFS)

    1 week to 6 months

Secondary Outcomes (1)

  • patient satisfaction

    1 week to 6 months

Study Arms (2)

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

two pieces obturatorOTHER

patient received two pieces obturator connecting by magnet attachment

Also known as: sectional obturator
conventional obturatorsectional obturator

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • exposed to radiotherpy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 11511, Egypt

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

July 5, 2021

First Posted

October 4, 2021

Study Start

March 1, 2018

Primary Completion

November 30, 2020

Study Completion

January 30, 2021

Last Updated

October 4, 2021

Record last verified: 2021-09

Locations

EG(1)