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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026428
Receipt No. R000030360
Scientific Title Development and clinical application of treatment for seasonal allergic rhinitis symptom caused by salivary secretory type IgA production.
Date of disclosure of the study information 2017/03/06
Last modified on 2018/10/17

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Basic information
Public title Development and clinical application of treatment for seasonal allergic rhinitis symptom caused by salivary secretory type IgA production.
Acronym Development of mouthpiece for seasonal allergic rhinitis symptom
Scientific Title Development and clinical application of treatment for seasonal allergic rhinitis symptom caused by salivary secretory type IgA production.
Scientific Title:Acronym Development of mouthpiece for seasonal allergic rhinitis symptom
Region
Japan

Condition
Condition Seasonal allergic rhinitis
Classification by specialty
Oto-rhino-laryngology Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is improvement allergy symptoms by increasing salivary secretory type IgA by wearing mouthpieces for patients with seasonal allergic rhinitis symptoms visiting Kanagawa Dental University Hospital.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Evaluate relief of allergic rhinitis symptoms before and after mouthpiece attachment by allergic rhinitis severity classification.
Key secondary outcomes Furthermore, changes in salivary secretion rate, salivary IgA concentration, salivary IL-33 concentration, and saliva properties are evaluated.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 The mouthpiece is set during the onset of allergic rhinitis symptoms (sneezing, runny nose, stuffy nose).
Interventions/Control_2 Normal subjects who did not develop pollen symptoms were used as a control group.
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
18 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria Hospitalized patients with symptoms of allergic rhinitis (house dust, PM 2.5 etc) visit our Kanagawa Dental hospital.
Key exclusion criteria 1) Those who are undergoing treatment due to infection with hemophilia, hepatitis, HIV, etc, and who are at risk of treatment due to high blood pressure, diabetes etc.
2) Pregnant women or lactating women
3) Person who has participated in the trial within 12 weeks before the start of this procedure
4) Person who judged that the dental clinic in charge is not appropriate for other reasons
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Tani-Ishii
Organization Department of Oral Integrated Medicine
Kanagawa Dental University
Division name Division of Pulp Biology
Zip code
Address 82, Yokosuka, Kanagawa
TEL 0468229527
Email n.ishii@kdu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyuki Tani-Ishii
Organization Department of Oral Integrated Medicine ,Kanagawa Dental University
Division name Division of Pulp Biology
Zip code
Address 82, Yokosuka, Kanagawa
TEL 0468229527
Homepage URL
Email n.ishii@kdu.ac.jp

Sponsor
Institute Department of Oral Integrated Medicine
Kanagawa Dental University
Institute
Department

Funding Source
Organization Japanaese goverment of science and culture
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 神奈川歯科大学附属病院

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 06 Day

Related information
URL releasing protocol http://www.hozon.or.jp/member/publication/abstract/file/abstract_146/A6-23_B6-20.pdf
Publication of results Partially published

Result
URL related to results and publications http://www.hozon.or.jp/member/publication/abstract/file/abstract_146/A6-23_B6-20.pdf
Number of participants that the trial has enrolled
Results
The symptoms of allergic rhinitis severity classification (from 0 to12 points) before and after mouthpiece attachment were significantly improved after the experimental group (before 9.7) (after 4.3), whereas the control group The salivary flow rate was measured as salivary secretion rate (micro g / min), and it was measured after the experimental group (0.6) before loading (after 1.0 +0.6), but the control group did not change (before 0.7) , (after 1.0)). As a result of multiple item saliva test, the mouthpiece of the experimental group An increase in acid buffering capacity was observed before and after mounting.
As a result of measuring the salivary IgA concentration (micro g /ml), the experimental group (10.4) before the mouthpiece was attached was significantly reduced compared to the control group (19.2). The salivary IgA concentration after wearing the mouthpiece did not change in both the experimental group and the control group, but the salivary IgA secretion rate (micro g/ min) in the experimental group.

Results: Rhinitis severity classification before and after NG was significantly improved before and after NG. As a result of measuring the saliva flow rate, it was significantly increased before and after NG. It was revealed that salivary IgA secretion concentration was significantly decreased in hay fever patients. Conclusion: NG used for dental care showed the possibility of alleviating symptoms of allergic rhinitis caused with pollinosis by increasing saliva amount and salivary IgA secretion rate.


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
2017 Year 03 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 07 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 06 Day
Last modified on
2018 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030360

Research Plan
Registered date File name
2018/05/16 2017総会石井花粉症abstract.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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