UMIN-CTR Clinical Trial

Basic information
Public title	Effect of the removable partial dentures and the rehabilitation for masticatory and swallowing function on patients with free-end edentulism: from the viewpoint of dysphagia
Acronym	Effect of the removable partial dentures and the rehabilitation for masticatory and swallowing function on patients with free-end edentulism: from the viewpoint of dysphagia
Scientific Title	Effect of the removable partial dentures and the rehabilitation for masticatory and swallowing function on patients with free-end edentulism: from the viewpoint of dysphagia
Scientific Title:Acronym	Effect of the removable partial dentures and the rehabilitation for masticatory and swallowing function on patients with free-end edentulism: from the viewpoint of dysphagia
Region	Japan

Condition
Condition	free-end edentulism, dysphagia, masticatory dysfunction
Classification by specialty	Oto-rhino-laryngology Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the frequency of patients with dysphagia in free-end edentulism and the possibility that removable partial dentures and additional oral rehabilitation can improve the severity of dysphagia. We also carry out the same evaluation to the patients without dysphagia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. The score of oral health-related qualit y of life Japanese version (OHIP-J54) 2. The glucose elusion from gummy jelly 3. Fiberoptic endoscopic examination of swallowing
Key secondary outcomes	The rate of patients with dysphagia in free-end edentulism

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	the installation of removable partial denture
Interventions/Control_2	oral rehabilitation
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with free-end edentulism distal from first premolar either in left or right side of the upper or the lower jaw
Key exclusion criteria	Patients paticipating another study. Patients who prefer to dental implant or implant over denture. Patients with congenital malformation, developmental disturbance, traumatic oral injury, inflammatory disease, or cancer. Patients who do not agree this research.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name keiichi Middle name Last name Sasaki
Organization	Tohoku University Graduate School of Dentistry
Division name	Advanced Prosthetic Dentistry
Zip code	980-8575
Address	4-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575, Japan
TEL	022-717-8368
Email	Keii@dent.tohoku.ac.jp

Public contact
Name of contact person	1st name makiko Middle name Last name Miyazaki
Organization	Tohoku University Graduate School of Medicine
Division name	Otolaryngology-Head and Neck Surgery
Zip code	980-8574
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL	022-717-7304
Homepage URL
Email	makiko.miyazaki.r2@dc.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Dentistry
Institute
Department

Funding Source
Organization	Tohoku University Graduate School of Medicine
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	MHLW Certified Clinical Research Review Board, Tohoku University
Address	2-1-1 Katahira, Aoba-ku, Sendai, Miyagi, 980-8577
Tel	022-718-0461
Email	office@nrs.hosp.tohoku.ac.jp

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	2018 Year 07 Month 24 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 06 Month 07 Day
Date of IRB	2018 Year 07 Month 25 Day
Anticipated trial start date	2018 Year 07 Month 24 Day
Last follow-up date	2023 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 07 Month 24 Day
Last modified on	2020 Year 02 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038185