The Effect of Obturator Thickness on the Function (obturator)

May 6, 2021 updated by: Dr. Merve Benli, Istanbul University

The Effect of the Wall Thickness of Obturator Bulbs on Masticatory Function in Patients With Maxillectomy

the effect of obturator bulb thickness on masticatory function has been verified.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Fatih, Turkey, 34452
        • Istanbul university,Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 71 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • having maxillectomy operation

Exclusion Criteria:

  • having radiation therapy before the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low group
low thickness group
Device: obturator
variable bulbs
Other Names:
  • bulb
Experimental: moderate group
moderate thickness group
Device: obturator
variable bulbs
Other Names:
  • bulb
Experimental: high group
high thickness group
Device: obturator
variable bulbs
Other Names:
  • bulb

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the effect of bulb thickness
Time Frame: 3 weeks
measuring the efficacy of masticatory function with chewing test
3 weeks
the effect of weight reduction
Time Frame: 3 weeks
measuring the weight differences of prostheses
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Study Director: merve benli, phd, Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2019

Primary Completion (Actual)

July 22, 2019

Study Completion (Actual)

September 12, 2019

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

May 6, 2021

First Posted (Actual)

May 11, 2021

Study Record Updates

Last Update Posted (Actual)

May 11, 2021

Last Update Submitted That Met QC Criteria

May 6, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1297

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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