UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013850 |
|---|---|
| Receipt number | R000016157 |
| Scientific Title | Assessment of the effect of administration of propolis and curry leaf into periodontal pockets on oral microbiota |
| Date of disclosure of the study information | 2014/05/01 |
| Last modified on | 2015/08/03 14:32:31 |
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Basic information
Public title
Assessment of the effect of administration of propolis and curry leaf into periodontal pockets on oral microbiota
Acronym
Assessment of the effect of propolis and curry leaf on oral microbiota
Scientific Title
Assessment of the effect of administration of propolis and curry leaf into periodontal pockets on oral microbiota
Scientific Title:Acronym
Assessment of the effect of propolis and curry leaf on oral microbiota
Region
| Japan |
Condition
Condition
Chronic periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of propolis and curry leaf on oral microbiota
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
periodontal pocket depth
quantity and quality of oral microbiota
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intervention-1: Placebo administration
Interventions/Control_2
Intervention-2: Minocycline administration
Interventions/Control_3
Intervention-3: Curry leaf administration
Interventions/Control_4
Intervention-4: Propolis administration
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Moderate periodontitis
Key exclusion criteria
Experience of taking any antibiotics within 6 months
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryoma Nakao |
Organization
National Institute of Infectious Diseases
Division name
Department of Bacteriology I
Zip code
Address
1-23-1, Toyama, Shinjuku, Tokyo
TEL
03-5285-1111
ryoma73@nih.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoma Nakao |
Organization
National Institute of Infectious Diseases
Division name
Department of Bacteriology I
Zip code
Address
1-23-1, Toyama, Shinjuku, Tokyo
TEL
03-5285-1111
Homepage URL
ryoma73@nih.go.jp
Sponsor or person
Institute
National Institute of Infectious Diseases
Institute
Department
Personal name
Funding Source
Organization
Yamada Reseach Grant
and
Urakami Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Departmentof Periodontology, Nihon University School of Dentistry at Matsudo
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
日本大学松戸歯学部付属病院歯周科(Department of Periodontology, Nihon University Hospital School of Dentistry at Matsudo)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 01 | 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
| 2014 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 30 | Day |
Last modified on
| 2015 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016157
