UMIN-CTR Clinical Trial

Basic information
Public title	Eeffects of Neem containing dentifrrice on oral condotions
Acronym	Eeffects of Neem containing dentifrrice on oral condotions
Scientific Title	Eeffects of Neem containing dentifrrice on oral condotions
Scientific Title:Acronym	Eeffects of Neem containing dentifrrice on oral condotions
Region	Japan

Condition
Condition	oral diseases
Classification by specialty	Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Eeffects of Neem containing dentifrrice on oral condotions such as accumulation of dntal plaque, inflammation of gingivitis and oral malodor.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	accumulation of dntal plaque using Neem containing dentifrice 4 weeks, 3times a day
Key secondary outcomes	inflammation of gingivitis,oral malodor and oral bacteria using Neem containing dentifrice 4 weeks, 3times a day

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	using with dentifrice with Neem mainly,4weeks, 3times a day
Interventions/Control_2	using dentifrice without Neem and other medicinal ingredients,4weeks, 3times a day
Interventions/Control_3	dentifrice without Neem and with other medicinal ingredients, 4weeks, 3times a day
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	40 years-old >
Gender	Male and Female
Key inclusion criteria	health adults without periodontal dosease or oral cavities
Key exclusion criteria	adults with sever periodontal disease or oral cavities or systemic diseases such as diabetes
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Kayoko Middle name Last name Shinada
Organization	Tokyo Medical and Dental University, Graduate school
Division name	Preventive oral health care science
Zip code	113-8459
Address	1-5-45 Yushima Bunkyo-ku Tokyo
TEL	03-5803-4096
Email	shinada.ohp@tmd.ac.jp

Public contact
Name of contact person	1st name Kayoko Middle name Last name Shinada
Organization	Tokyo Medical and Dental University, Graduate school
Division name	Preventive oral health care science
Zip code	113-8549
Address	1-5-45 Yushima Bunkyo-ku Tokyo
TEL	03-5803-4096
Homepage URL
Email	shinada.ohp@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University, Graduate school Preventive oral health care science
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Medical and Dental University, Graduate school Preventive oral health care science
Address	1-5-45 Yushima Bunkyo-ku Tokyo Japan
Tel	03-5803-4096
Email	shinada.ohp@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	2020 Year 10 Month 30 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	2020 Year 03 Month 01 Day
Date of IRB	2020 Year 04 Month 10 Day
Anticipated trial start date	2020 Year 04 Month 15 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2020 Year 01 Month 23 Day
Last modified on	2020 Year 01 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044470