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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023456
Receipt No. R000026030
Scientific Title Randomized control stuy for the effect of dentifrice including mastic and fulvic acid on periodontal symptoms
Date of disclosure of the study information 2016/08/03
Last modified on 2016/08/03

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Basic information
Public title Randomized control stuy for the effect of dentifrice including mastic and fulvic acid on periodontal symptoms
Acronym Effect of dentifrice including mastic and fulvic acid
Scientific Title Randomized control stuy for the effect of dentifrice including mastic and fulvic acid on periodontal symptoms
Scientific Title:Acronym Effect of dentifrice including mastic and fulvic acid
Region
Japan

Condition
Condition periodontal disease
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluate the effect of dentifrice including mastic and fulvic acid on periodontal symptoms using randomized controlled study
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes clinical parameters such as swelling and redness of gingiva, bleeding, discharge of pus, periodontal pocket depth, moving of teeth, halitosis and whiteness of teeth were evaluated at start of dentifrice usage,4,8 and 12 weeks later
Key secondary outcomes microbiological test was performed at dentifrice usage, 4, 8 and 12 weeks later

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Dentifrice A:Mastic essential oil(0.01g)
Instructed to use dentifrice(1g),1cm for 7 min twice a day(morning, evening) during 12 weeks.
Interventions/Control_2 Dentifrice B: Mastic essential oil(0.01g)+ Fulvic acid(10g)
Instructed to use dentifrice(1g),1cm for 7 min twice a day(morning, evening) during 12 weeks.
Interventions/Control_3 Dentifrice (Placebo): without Mastic and Fulvic acid and same as others
Instructed to use dentifrice(1g),1cm for 7 min twice a day(morning, evening) during 12 weeks.
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 Chronic periodontitis patients who did not received scaling at observed site within 6 months and are at first visit or plaque control stage.
Key exclusion criteria A) Systemic diseases which affect to periodontal tissue
B) Severe periodontal diseases
C) Anteriol teeth lost or applied orthodontic apparatus
D) Pregnant or lactating woman
E) Antibiotics experience within 3 months
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisashi Watanabe
Organization Tokyo Medical and Dental University
Division name Graduate School of Medical and Dental Sciences, Department of Periodontology
Zip code
Address 1-5-45, Yushima Bunkyo-ku Tokyo
TEL 03-5803-5487
Email watanabe.peri@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiho Sato
Organization Tokyo Medical and Dental University
Division name the general affairs section
Zip code
Address 1-5-45, Yushima Bunkyo-ku Tokyo
TEL 03-5803-5404
Homepage URL
Email rec.adm@tmd.ac.jp

Sponsor
Institute the Ministry of Welfare and Labor
Institute
Department

Funding Source
Organization Zeria Pharmaceutical 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
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

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 03 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 Preinitiation
Date of protocol fixation
2016 Year 06 Month 03 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 03 Day
Last modified on
2016 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026030

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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