UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046865 |
|---|---|
| Receipt number | R000053465 |
| Scientific Title | A study on professional oral care and saliva IgA concentration |
| Date of disclosure of the study information | 2022/02/10 |
| Last modified on | 2024/08/18 11:25:45 |
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Basic information
Public title
A study on oral care and saliva IgA
Acronym
Oral care and saliva IgA
Scientific Title
A study on professional oral care and saliva IgA concentration
Scientific Title:Acronym
Professional oral care and saliva IgA concentration
Region
| Japan |
Condition
Condition
Oral disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Since salivary IgA fluctuates under the influence of intestinal bacteria, the effects of probiotics and prebiotics have been revealed, and attention has been focused on the intestinal-salivary gland correlation. Although probiotics and prebiotics improve the intestinal microflora by dietary factors, the influx of periodontal pathogenic bacteria from the oral cavity is thought to be an aggravating factor and may be involved in the decrease in salivary IgA, but this has not been sufficiently proven. Therefore, we will clarify whether inhibiting the influx of oral bacteria into the intestinal tract by oral care affects the formation of salivary IgA, and investigate whether the reason for this is a change in the bacterial flora of the intestinal tract. The ultimate goal of this research is to develop an innovative saliva IgA test that can evaluate the effects of oral care via the intestinal tract.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
By inhibiting the influx of oral bacteria into the intestinal tract through oral care, the index will be whether salivary IgA increases after 2 weeks compared to before the intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
In addition to the full mouth disinfection concept proposed by Quirynen of Catholic University, a medium to long chain split polyphosphoric acid solution is applied instead of chlorhexidine used in Quirynen's method. While suppressing odontogenic bacteremia, normal scaling is performed on the entire jaw in a short period of time to remove plaque and tartar, including biofilm, from the tooth surface, periodontal tissue, tongue and oral mucosa.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with periodontal disease who have had an intraoral examination (conventional periodontal examination: X-ray, PCR, probing, etc.).
Key exclusion criteria
Patients with intestinal diseases.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Tsukinoki |
Organization
Kanagawa Dental University
Division name
School of Dentistry
Zip code
2388580
Address
82, Inaoka, Yokosuka, Kanagawa
TEL
0468228866
tsukinoki@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Tsukinoki |
Organization
Kanagawa Dental University
Division name
School of Dentistry
Zip code
2388580
Address
82, Yokosuka, Kanagawa
TEL
0468228866
Homepage URL
tsukinoki@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KDU IRB
Address
82, Inaoka, Yokosuka, Kanagawa
Tel
0468251500
graduate@kdu.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
| 2022 | Year | 02 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2022 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 02 | Month | 08 | Day |
Last modified on
| 2024 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053465
