NCT04881669

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 11, 2021

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

5 months

First QC Date

May 3, 2021

Last Update Submit

May 6, 2021

Conditions

Maxilla--Cancer

Keywords

obturator, bulb

Outcome Measures

Primary Outcomes (2)

  • the effect of bulb thickness

    measuring the efficacy of masticatory function with chewing test

    3 weeks

  • the effect of weight reduction

    measuring the weight differences of prostheses

    3 weeks

Study Arms (3)

low group

EXPERIMENTAL

low thickness group

Device: obturator

moderate group

EXPERIMENTAL

moderate thickness group

Device: obturator

high group

EXPERIMENTAL

high thickness group

Device: obturator

Interventions

obturatorDEVICE

variable bulbs

Also known as: bulb
high grouplow groupmoderate group

Eligibility Criteria

Age16 Years - 71 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • having maxillectomy operation

You may not qualify if:

  • having radiation therapy before the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul university,Faculty of Dentistry

Fatih, 34452, Turkey (Türkiye)

Location

Study Officials

  • merve benli, phd

    Istanbul University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 3, 2021

First Posted

May 11, 2021

Study Start

March 6, 2019

Primary Completion

July 22, 2019

Study Completion

September 12, 2019

Last Updated

May 11, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

TU(1)