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A 8 week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of oraCMU on oral health

Status Approved

First Submitted Date

2019/09/03
Registered Date

2019/09/10
Last Updated Date

2019/09/06

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0004291
Unique Protocol ID	CRI19008
Public/Brief Title	The efficacy and safety of oraCMU on oral health
Scientific Title	A 8 week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of oraCMU on oral health
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	CRI19008
Approval Date	2019-08-02
Institutional Review Board Name	Seoul National University Dental Hospital Institutional Review Board
Institutional Review Board Address	101, Daehak-ro, Jongno-gu, Seoul
Institutional Review Board Telephone	02-2072-3057
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Sungtae Kim
Title	Professor
Telephone	+82-2-2072-4712
Affiliation	Seoul National University Dental Hospital
Address	101, Daehak-ro, Jongno-gu, Seoul
Contact Person for Public Queries
Name	Dajung Lee
Title	Researcher
Telephone	+82-2-2072-3055
Affiliation	Seoul National University Dental Hospital
Address	101, Daehak-ro, Jongno-gu, Seoul
Contact Person for Updating Information
Name	Suhyun Seo
Title	Researcher
Telephone	+82-2-2072-3044
Affiliation	Seoul National University Dental Hospital
Address	101, Daehak-ro, Jongno-gu, Seoul

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2019-09-06 Actual
Target Number of Participant	100
Primary Completion Date	2020-08-01 , Anticipated
Study Completion Date	2020-08-01 , Anticipated
Name of Study	Seoul National University Dental Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2019-09-06 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Ministry of Agriculture, Food and Rural Affairs
Organization Type	Government
Project ID
2. Source of Monetary/Material Support
Organization Name	Oradentics
Organization Type	Others
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Seoul National University Dental Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	The purpose of this study is elucidate the effect of probiotics oraCMU on oral health in healthy adults and seniors with halitosis. The study is designed as an 8 week, randomized, placebo-controlled, double-blind, parallel study.

Study Summary Information

Lay Summary

The purpose of this study is elucidate the effect of probiotics oraCMU on oral health in healthy adults and seniors with halitosis. The study is designed as an 8 week, randomized, placebo-controlled, double-blind, parallel study.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Others
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Dietary Supplement
Intervention Description	Within 2-week run-in period, enrolled subjects will be randomly assigned to treatment or placebo groups at visit 2 (week 0). The subjects will be asked to consume 1 tablet a day during the 8-week trial.
Number of Arms	2
Arm 1	Arm Label Placebo
	Target Number of Participant 50
	Arm Type Placebo comparator
	Arm Description During the 8-week trial, placebo group will be assigned to consume 1 tablet a day without probiotics.
Arm 2	Arm Label Experimental
	Target Number of Participant 50
	Arm Type Experimental
	Arm Description During the 8-week trial, experimental group will be assigned to consume 1 tablet a day with probiotics.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (R00-R99)Symptoms, signs and abnormal clinical and laboratory findings, NEC (R19.6)Halitosis Healthy adults and seniors with halitosis
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~70Year
	Description 1) Those who voluntarily agree to participate in this study and sign in informed consent form 2) Men and women between 20 and 70 years old 3) Those who have 20 or more natural teeth excluding wisdom teeth 4) Those who without tongue diseases 5) A person with volatile sulfur compounds concentration of 1.5 ng/10 ml or more 6) Persons without severe periodontal disease, rampant caries, less than five dental caries to be treated immediately
Exclusion Criteria	1) Those who have communication problem with investigators 2) Those who have mental diseases 3) Those who are currently being treated with systemic disease that may cause bad breath 4) Those who have a diagnosis of sinusitis or rhinitis 5) Those taking antibiotics within 1 month before the first visit 6) Those who have a diagnosis of chronic gastritis 7) Those with uncontrolled hypertension 8) Diabetic patients taking hypoglycemic agents 9) Those who consume food or health functional food with probiotics within 1 week before the first visit 10) Those who have hypersensitivity or allergy to probiotics including dairy food 11) Those taking warfarin or aspirin 12) Those who have aspiration risk 13) Those who have dry mouth 14) Persons with severe periodontal disease, rampant caries, five or more dental caries to be treated immediately 15) Pregnant or lactating women, or with pregnancy plan during the study period 16) Those who have participated in other clinical trials within 6 months before participating in this study 17) Those who are deemed by the investigator to be unsuitable for this study
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Halitosis, gingival index, periodontal bacteria
Timepoint	0,4,8week
Secondary Outcome(s) 1
Outcome	Psychosocial health survey
Timepoint	0,8week
Secondary Outcome(s) 2
Outcome	Blood test
Timepoint	0,8week

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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