UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023456 |
|---|---|
| Receipt number | 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 | 2022/08/11 14:31:07 |
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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 | Hisashi |
| Middle name | |
| Last name | Watanabe |
Organization
Tokyo Medical and Dental University
Division name
Graduate School of Medical and Dental Sciences, Department of Periodontology
Zip code
113-8510
Address
1-5-45, Yushima Bunkyo-ku Tokyo
TEL
03-5803-5487
watanabe.peri@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Akiho |
| Middle name | |
| Last name | Sato |
Organization
Tokyo Medical and Dental University
Division name
the general affairs section
Zip code
113-8510
Address
1-5-45, Yushima Bunkyo-ku Tokyo
TEL
03-5803-5404
Homepage URL
rec.adm@tmd.ac.jp
Sponsor or person
Institute
the Ministry of Welfare and Labor
Institute
Department
Personal name
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
IRB at Tokyo Medical and Dental University, Dental School
Address
1-5-45, Yushima Bunkyo-ku Tokyo
Tel
03-5803-5404
rec.adm@tmd.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
| 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 30 | Day |
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
| 2022 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026030
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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