UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013731 |
|---|---|
| Receipt number | R000016032 |
| Scientific Title | Placebo-controlled randomized trial on the saliva secretion effect of interferential current stimulation |
| Date of disclosure of the study information | 2014/04/21 |
| Last modified on | 2017/02/06 14:53:53 |
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Basic information
Public title
Placebo-controlled randomized trial on the saliva secretion effect of interferential current stimulation
Acronym
Saliva secretion effect of interferential current stimulation
Scientific Title
Placebo-controlled randomized trial on the saliva secretion effect of interferential current stimulation
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yoko Hasegawa |
Organization
Hyogo College of Medicine
Division name
Department of Dentistry and Oral & Maxillofacial Surgery
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL
0798-45-6677
cem17150@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoko Hasegawa |
Organization
Hyogo College of Medicine
Division name
Department of Dentistry and Oral & Maxillofacial Surgery
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL
0798-45-6677
Homepage URL
cem17150@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
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
Main results already published
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016032
