UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040888
Receipt number R000046692
Scientific Title A prospective observational study of the impact of wearing dentures on swallowing function
Date of disclosure of the study information 2020/06/26
Last modified on 2021/12/31 09:17:10

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Basic information

Public title

A prospective observational study of the impact of wearing dentures on swallowing function

Acronym

A prospective observational study of the impact of wearing dentures on swallowing function

Scientific Title

A prospective observational study of the impact of wearing dentures on swallowing function

Scientific Title:Acronym

A prospective observational study of the impact of wearing dentures on swallowing function

Region

Japan


Condition

Condition

dysphagia

Classification by specialty

Rehabilitation medicine Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effect of the presence or absence of dentures on pharyngeal swallowing function in patients with dysphagia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The Normalized Residue Ratio Scale: NRRS

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

1 years-old <=

Age-upper limit

120 years-old >

Gender

Male and Female

Key inclusion criteria

patients who need speech therapy
patients who need videofluoroscopic examination
patients who use dentures
patients who can agree to participate in this research

Key exclusion criteria

patients with dementia
patients with dysphagia by local pharyngeal causes

Target sample size

27


Research contact person

Name of lead principal investigator

1st name Norimasa
Middle name
Last name Katagiri

Organization

Seirei Mikatahara General Hospital

Division name

Rehabilitation department

Zip code

433-8558

Address

3453 Mikatahara-cho, Kita-ku, Hamamatsu, Shizuoka

TEL

053-436-1251

Email

tkgdsk1015@gmail.com


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Takagi

Organization

Seirei Mikatahara General Hospital

Division name

Rehabilitation department

Zip code

433-8558

Address

3453 Mikatahara-cho, Kita-ku, Hamamatsu, Shizuoka

TEL

053-436-1251

Homepage URL


Email

tkgdsk1015@gmail.com


Sponsor or person

Institute

Seirei Mikatahara General Hospital

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Seirei Mikatahara General Hospital

Address

3453 Mikatahara-cho, Kita-ku, Hamamatsu, Shizuoka

Tel

053-436-1251

Email

tkgdsk1015@gmail.com


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2020 Year 06 Month 26 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

27

Results

The mean age of the 27 participants was 86.1 (6.8) years. The vallecular residue was more in those without dentures (with dentures: 0.01 [0 - 0.02], without dentures: 0.03 [0 - 0.08]; P = 0.003). The pyriform sinus residue showed no significant difference. Denture removal significantly increased the pharyngeal area. The distance between the maxilla and mandible decreased in the absence of dentures. Oral/pharyngeal transit time was prolonged without dentures.

Results date posted

2021 Year 12 Month 31 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 08 Month 05 Day

Baseline Characteristics

Inpatients of Seirei Mikatahara General Hospital and Hamamatsu City Rehabilitation Hospital during the study period were included.
Inclusion criteria were: (i) patients examined using the VFSS due to dysphagia, and (ii) those who lost all their teeth, either in the maxilla, mandible, or completely edentulous patients; (iii) those who always use dentures during the day; or (iv) those who have well-fitting dentures diagnosed by dentists (including those who received denture treatment). In contrast, exclusion criteria were as follows: (i) those with impaired consciousness; (ii) those with severe cognitive impairment and an inability to follow instructions; and/or (iii) those who have not recovered the denture fitting after denture treatment.

Participant flow

Based on the inclusion and exclusion criteria, informed consent was obtained from the participants by signature after receiving a written explanation of the study.

Adverse events

none

Outcome measures

Sex, age, main disease name, denture type, BMI, FILS, grip strength, pharyngeal residue (NRRS), pharyngeal area, maxillary-mandibular distance, displacement of the hyoid bone and larynx, UES opening, oral/pharyngeal transit time, PA-scale, subjective swallowing difficulty and residual sensation.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 03 Month 21 Day

Date of IRB

2019 Year 05 Month 20 Day

Anticipated trial start date

2019 Year 06 Month 01 Day

Last follow-up date

2021 Year 01 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To clarify the effect of wearing dentures on videofluoroscopic examination of swallowing.


Management information

Registered date

2020 Year 06 Month 24 Day

Last modified on

2021 Year 12 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046692


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name