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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029554
Receipt No. R000028717
Scientific Title Study on Clinical Effects of Toothpaste Containing Propolis in Periodontitis Patients
Date of disclosure of the study information 2017/10/14
Last modified on 2017/10/14

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Basic information
Public title Study on Clinical Effects of Toothpaste Containing Propolis in Periodontitis Patients
Acronym Effects of Toothpaste Containing Propolis in Periodontitis Patients
Scientific Title Study on Clinical Effects of Toothpaste Containing Propolis in Periodontitis Patients
Scientific Title:Acronym Effects of Toothpaste Containing Propolis in Periodontitis Patients
Region
Japan

Condition
Condition Periodontitis
Classification by specialty
Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This clinical study aimed to evaluate the clinical effects of the toothpaste containing propolis by comparison to the tooth paste not counting propolis in randomized controlled trial.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Amounts of bacteria in sub-gingival dental plaque after 4 weeks
(Total bacteria and Porphyromonas gingivivalis)
Key secondary outcomes Nine points after 4 weeks
1) Probing pocket depth
2) Bleeding on probing
3) Activity of neutrophil elastase and total protein amounts in saliva
4) Ammonia in saliva
5) Cariogenic activity of saliva: amounts of cariogenic bacteria, acidity, buffer capacity
6) Microflora of sub-gingival dental plaque analyzed by next generation sequencer (2 subjects/group)
7) Questionnaire for impression of use of this toothpaste and its effective
8) Record of implementation
9) Questionnaire for the condition of pre-existing disease

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Tooth brushing with given toothbrush and toothpaste containing 5 mg/g propolis twice a day for 4 weeks
Interventions/Control_2 Tooth brushing with given toothbrush and toothpaste not containing propolis twice a day for 4 weeks
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Periodontitis patients in supportive periodontal therapy (SPT) phase (consulting period: more than 2 months interval) at Department of Periodontics and Endodontics of Okayama University Hospital
2) Good oral hygiene; good compliance during study period, judged by research dentist
3) Age is not less than 20 years old when obtaining informed consent.
4) Current number of teeth is not less than 20.
5) Patients with 3 or more teeth with 4- to 6-mm periodontal pocket
6) Patients with informed consent by document agree
Key exclusion criteria 1) Allergic for this toothpaste
2) Pregnancy or lactating period women
3) Unstable physical condition
4) Use of antibiotics / anti-inflammatory agents within 3 months
5) Acute symptom of periodontitis within 3 months
6) Smoker
7) Unifit patients judged by research dentists for compliance
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shogo Takashiba
Organization Okayama University
Division name Department of Pathophysiology - Periodontal Science, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525, Japan
TEL 086-235-6675
Email stakashi@okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shogo Takashiba
Organization Okayama University
Division name Department of Pathophysiology - Periodontal Science, Okayama University Graduate School of Medicine,
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525, Japan
TEL 086-235-6675
Homepage URL
Email stakashi@okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization API Co., Ltd.
Business Strategy Section
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 岡山大学病院(岡山市)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 14 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 Enrolling by invitation
Date of protocol fixation
2017 Year 01 Month 29 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
2017 Year 08 Month 31 Day
Date of closure to data entry
2017 Year 10 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 10 Month 14 Day
Last modified on
2017 Year 10 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028717

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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