UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018305 |
|---|---|
| Receipt number | R000021186 |
| Scientific Title | Effects of Pycnogenol chewing gum on oral malodor, gingivitis and plaque formation |
| Date of disclosure of the study information | 2015/07/14 |
| Last modified on | 2015/07/16 13:52:41 |
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Basic information
Public title
Effects of Pycnogenol chewing gum on oral malodor, gingivitis and plaque formation
Acronym
Effects of Pycnogenol chewing gum on oral health
Scientific Title
Effects of Pycnogenol chewing gum on oral malodor, gingivitis and plaque formation
Scientific Title:Acronym
Effects of Pycnogenol chewing gum on oral health
Region
| Japan |
Condition
Condition
oral malodor, gingivitis, periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the inhibitory effects of chewing gum containing Pycnogenol on oral malodor, gingival inflammation, and plaque formation in the general adult population.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reduction of oral malodor, plaque formation and improvement of gingivitis at baseline, 2 weeks and 4 weeksr
Key secondary outcomes
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
The subjects were instructed to chew 2 pieces of pycnogenol gum (5 mg) 6 times daily for 15 min during the intake period (4 weeks).
Interventions/Control_2
The subjects were instructed to chew 2 pieces of pycnogenol gum (10 mg) 6 times daily for 15 min during the intake period (4 weeks).
Interventions/Control_3
The subjects were instructed to chew 2 pieces of placebo gum 6 times daily for 15 min during the intake period (4 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
participant without systemic diseases
Key exclusion criteria
under dental treatment
antibacterial therapy within the previous 30 days
smoker
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoko Watanabe |
Organization
Kanagawa Dental University
Division name
Department of Microbiology
Zip code
Address
82 Inaoka-cho, Yokosuka
TEL
+81-46-822-8867
watanabe@kdu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyoko Watanabe |
Organization
Kanagawa Dental University
Division name
Department of Microbiology
Zip code
Address
82 Inaoka-cho, Yokosuka
TEL
+81-46-822-8867
Homepage URL
watanabe@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Dental University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
神奈川歯科大学
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | 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
Completed
Date of protocol fixation
| 2010 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 28 | 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
| 2015 | Year | 07 | Month | 14 | Day |
Last modified on
| 2015 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021186
