UMIN-CTR Clinical Trial

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
Institute	Seirei Mikatahara General Hospital
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046692