UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026428 |
|---|---|
| Receipt number | 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 16:40:12 |
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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
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
n.ishii@kdu.ac.jp
Sponsor or person
Institute
Department of Oral Integrated Medicine
Kanagawa Dental University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
