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

NCT ID: NCT05066828

Last Updated: 2021-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2021-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patient Satisfaction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

conventional obturator

Participants received conventional obturator one piece

Group Type ACTIVE_COMPARATOR

two pieces obturator

Intervention Type OTHER

patient received two pieces obturator connecting by magnet attachment

sectional obturator

two pieces obturators connected by magnet attachments

Group Type EXPERIMENTAL

two pieces obturator

Intervention Type OTHER

patient received two pieces obturator connecting by magnet attachment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

two pieces obturator

patient received two pieces obturator connecting by magnet attachment

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

sectional obturator

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* exposed to radiotherpy
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sharaf Mohamed Yahia

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cairo University

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

214/2018

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.