UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Placebo-controlled randomized trial on the saliva secretion effect of interferential current stimulation
Title of the study (Brief title)	Saliva secretion effect of interferential current stimulation
Region	Japan

Condition
Condition	Healthy subjects and patients with xerostomia
Classification by specialty	Medicine in general Geriatrics Oral surgery Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To test the efficacy of interferential current stimulation to facilitate saliva secretion in healthy young adults, healthy elder subjects, and patients with xerostomia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Amount of secreted saliva
Key secondary outcomes	Cortisol concentration in saliva

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	placement of electrodes only
Interventions/Control_2	interferential current stimulation
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Young adults aged between 20 - 30 years old who do not receive any medication. Elder adults aged between 50 and 90 years old who do not receive medication that reduces saliva secretion. Saliva production of patients with xerostomia, who administer the department of dentistry and oral & maxillofacial surgery, is quantified by the Saxon test; patients with the saliva volume less than 2g are eligeable for the study.
Key exclusion criteria	1. Those who have apparent cognitive impairment (MMSE < 20) 2. Patients with ataxia or dyskinesia 3. Patients who experienced apparent aspiration pneumonia or asphyxia twice within the past two years 4. Those who are judged by a doctor as inappropriate candidates
Target sample size	60

Research contact person
Name of lead principal investigator	Yoko Hasegawa
Organization	Hyogo College of Medicine
Division name	Department of Dentistry and Oral & Maxillofacial Surgery
Address	1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL	0798-45-6677
Email	cem17150@hyo-med.ac.jp

Public contact
Name of contact person	Yoko Hasegawa
Organization	Hyogo College of Medicine
Division name	Department of Dentistry and Oral & Maxillofacial Surgery
Address	1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL	0798-45-6677
Homepage URL
Email	cem17150@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Hyogo College of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	兵庫医科大学病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 21 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 04 Month 01 Day
Anticipated trial start date	2014 Year 04 Month 21 Day
Last follow-up date	2014 Year 09 Month 25 Day
Date of closure to data entry	2014 Year 09 Month 25 Day
Date trial data considered complete	2014 Year 09 Month 25 Day
Date analysis concluded	2014 Year 11 Month 11 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Hasegawa Y, Sugahara K, Sano S, Sakuramoto A, Kishimoto H, Oku Y. Enhanced salivary secretion by interferential current stimulation in subjects with dry mouth: a pilot study. Oral Surg. Oral Med. Oral Pathol. Oral Radiol., 121(5):481-9. doi: 10.1016/j.oooo.2016.01.017. Epub 2016 Feb 13. [Abstract] The quantity of saliva was significantly increased in Dry mouth subjects who received interferential current stimulation (IFCS) compared to those who did not receive IFCS (p=0.03). This significant difference was not found in the Young and Elderly subjects. There were no significant differences in VAS values of pain and discomfort or in the stress marker levels between three populations with and without IFCS.
Other related information

Management information
Registered date	2014 Year 04 Month 16 Day
Last modified on	2017 Year 02 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016032