UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052974 |
|---|---|
| Receipt number | R000060433 |
| Scientific Title | Effect of toothpaste containing fennel extract on the oral environment of patients with periodontal disease: a 4-week randomized controlled trial |
| Date of disclosure of the study information | 2023/12/18 |
| Last modified on | 2023/12/01 15:23:36 |
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Basic information
Public title
Effect of toothpaste containing fennel extract on the oral environment of patients with periodontal disease
Acronym
Effect of toothpaste containing fennel on periodontal disease
Scientific Title
Effect of toothpaste containing fennel extract on the oral environment of patients with periodontal disease: a 4-week randomized controlled trial
Scientific Title:Acronym
A randomized controlled trial to examine effect of toothpaste containing fennel on periodontal disease
Region
| Japan |
Condition
Condition
Periodontal disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to determine the effect of toothpaste containing fennel extract on the oral environment in patients with periodontal disease in a two-arm, double-blind, placebo-controlled, randomized, controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of total bacteria and periodontal pathobionts in saliva and gingival crevicular fluid
Key secondary outcomes
1. Microbiota in saliva and gingival crevicular fluid
2. Probing pocket depth (PPD)
3. Clinical attachment loss (CAL)
4. Tooth mobility
5. Bleeding on probing (BOP)
6. Gingival index (GI)
7. Plaque index (PlI)
8. Plaque control record (PCR)
9. Periodontal epithelial surface area (PESA)
10. Periodontal inflamed surface area (PISA)
11. X-ray examination
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
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Use of toothpaste containing fennel extract twice daily after meals, morning and evening, for four weeks
Interventions/Control_2
Use of toothpaste placebo twice daily after meals, morning and evening, for four 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. Patients with periodontal disease who have more than 3 PPDs that are deeper than 5 mm
2. Patients who do not currently smoke
3. Patients with no food or drug allergies
4. Patients who have not taken any antimicrobial agents (including over-the-counter drugs) within 6 months prior to the date of enrollment.
Key exclusion criteria
1. Patients who are pregnant or may be pregnant
2. Patients with uncontrolled diabetes, severe heart disease, renal dysfunction, hepatic dysfunction, etc. for which the dentist in charge deems inappropriate.
3. Patients who are taking antibody drugs or anti-inflammatory drugs for autoimmune diseases, etc.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yorimasa |
| Middle name | |
| Last name | Ogata |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Department of Periodontology
Zip code
271-8597
Address
2-870-1, Sakae-cho nishi, Matsudo, Chiba 271-8587
TEL
047-368-6111
ogata.yorimasa@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Yorimasa |
| Middle name | |
| Last name | Ogata |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Department of Periodontology
Zip code
271-8597
Address
2-870-1, Sakae-cho nishi, Matsudo, Chiba 271-8587
TEL
047-368-6111
Homepage URL
ogata.yorimasa@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Dentistry at Matsudo
Institute
Department
Personal name
Funding Source
Organization
S&B FOODS INC.
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
Nihon University School of Dentistry at Matsudo
Address
2-870-1, Sakae-cho nishi, Matsudo, Chiba 271-8587
Tel
047-368-6111
ogata.yorimasa@nihon-u.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
| 2023 | Year | 12 | Month | 18 | 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
| 2023 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2023 | Year | 12 | Month | 01 | Day |
Last modified on
| 2023 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060433
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