UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050521 |
|---|---|
| Receipt number | R000057533 |
| Scientific Title | A Pilot study of periodontopathic Bacterial Load suppression Efficacy Assessment of biofilm Cleaning in Healthy volunteers and patients with mild periodontitis |
| Date of disclosure of the study information | 2023/03/07 |
| Last modified on | 2024/07/03 08:52:10 |
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Basic information
Public title
A Pilot study of periodontopathic Bacterial Load suppression Efficacy Assessment of biofilm Cleaning in Healthy volunteers and patients with mild periodontitis
Acronym
A Pilot study of periodontopathic Bacterial Load suppression Efficacy Assessment of biofilm Cleaning in Healthy volunteers and patients with mild periodontitis
Scientific Title
A Pilot study of periodontopathic Bacterial Load suppression Efficacy Assessment of biofilm Cleaning in Healthy volunteers and patients with mild periodontitis
Scientific Title:Acronym
P-BLEACH study
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of biofilm removal on the improvement of the oral environment (inhibition of growth of periodontopathogenic bacteria and improvement of clinical indicators) in healthy individuals with periodontopathogenic bacteria detected in the oral cavity and who requested dental treatment (Professional Mechanical Tooth Cleaning / PMTC) on all teeth.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount and change of periodontopathogenic bacteria (P. gingivalis and F. nucleatum bacteria) in stimulated saliva measured by PCR invader method
Key secondary outcomes
Measurement at each observation point and change from baseline to each observation point of following items;
1. Amount of periodontopathogenic bacteria (P. gingivalis and F. nucleatum bacteria) in stimulated saliva measured by PMA-qPCR method
2. Amount of other bacteria (Campylobacter concisus) in stimulated saliva
3. Characteristics of stimulated saliva (pH, amount)
4. Concentration of calprotectin in stimulated saliva
5. Concentration of vascular endothelial growth factor (VEGF) and human epidermal growth factor (hEGF) in stimulated saliva
6. clinical indicators (gingival index (GI), plaque index (PI), bleeding on probing (BOP), probing depth (PD), clinincal attachment level (CAL), and tongue coating score)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Dental treatment (Professional Mechanical Tooth Cleaning / PMTC) is performed to healthy individuals.
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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy individuals who meet all of the following criteria are included in this study;
<Inclusion criteria for provisional registration>
1. Male or female aged 30 year or older and 65 year or younger
2. Individuals who generally take meals three times per day
3. Individuals in whom labial and buccal surfaces of at least 4 teeth among the following teeth are measurable; FDI tooth number 16 (maxillary right first molar, 21 (maxillary left central incisor), 36 (mandibular left first molar), 41 (mandibular right central incisor), 44 (mandibular right first premolar)
or healthy individuals who have the following teeth in place of the 6 teeth mentioned above; FDI tooth number 17, 15, 11, 22, 25, 37, 35, 31, 42, 45
4. Individuals with 20 teeth or more
5. Individuals without habit of polishing tongue at teeth brushing
6. Individuals who provide their consent to participate in this study in written form after full explanation of this study
<Inclusion criteria for actual registration>
7. Individuals in whom P. gingivalis is detected at the screening test
Key exclusion criteria
Patients who fall into any of the following criteria are excluded from participating in the study;
1. Individuals with smoking habit
2. Individuals who are taking medical agents due to diabetes mellitus, chronic renal disease, gastrointestinal disorder, pulmonary disease, malignant tumor, etc.
3. Individuals who routinely use products that inhibit periodontopathogenic bacteria, such as mouth wash agents
4. Individuals whose stimulant saliva is 3.0mL or less
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Hasegawa |
Organization
Aichi gakuin University
Division name
Department of Microbiology, School of Dentistry
Zip code
464-8650
Address
1-100 Kusumoto-cho, Chikusa-ku, Nagoya, Aichi
TEL
052-751-2561
yhase@dpc.agu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Takayama |
Organization
Soiken, Inc.
Division name
Clinical Study Support Division
Zip code
101-0052
Address
NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
TEL
03-3295-1350
Homepage URL
takayama@soiken.com
Sponsor or person
Institute
Aichi gakuin University
Institute
Department
Personal name
Funding Source
Organization
Yakult Honsha Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Gakuin University, School of Dentistry, Ethics Committee
Address
1-100 Kusumoto-cho, Chikusa-ku, Nagoya, Aichi
Tel
052-751-2561
none
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
| 2023 | Year | 03 | Month | 07 | 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
10
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
Completed
Date of protocol fixation
| 2022 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 01 | 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
| 2023 | Year | 03 | Month | 07 | Day |
Last modified on
| 2024 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057533
