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A 8 week, multi-center, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of MAEC on gingival health

Status Approved

First Submitted Date

2020/10/28
Registered Date

2020/11/03
Last Updated Date

2020/10/26

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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	KCT0005569
Unique Protocol ID	2-2019-0025
Public/Brief Title	A 8 week, multi-center, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of MAEC on gingival health
Scientific Title	A 8 week, multi-center, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of MAEC on gingival health
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
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	2-2019-0025
Approval Date	2019-07-30
Institutional Review Board Name	Yonsei University Dental Hospital, Institutional Review Board
Institutional Review Board Address	50-1, Yonsei-ro, Seodaemun-gu, Seoul
Institutional Review Board Telephone	02-2228-8613
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	Jaekook Cha
Title	Ph.D
Telephone	+82-2-2228-3191
Affiliation	Yonsei University Health System, Dental Hospital
Address	50-1, Yonsei-ro, Seodaemun-gu, Seoul
Contact Person for Public Queries
Name	Jaekook Cha
Title	Ph.D
Telephone	+82-2-2228-3191
Affiliation	Yonsei University Health System, Dental Hospital
Address	50-1, Yonsei-ro, Seodaemun-gu, Seoul
Contact Person for Updating Information
Name	Boyoung Kim
Title	manager
Telephone	+82-70-7771-4214
Affiliation	Neonutra
Address	4F, 44 Deahak-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	Multi-center Number of center : 3
Overall Recruitment Status	Completed
Date of First Enrollment	2019-09-23 Actual
Target Number of Participant	100
Primary Completion Date
Study Completion Date
Name of Study	Yonsei University Health System, Dental Hospital
Recruitment Status	Completed
Date of First Enrollment	2019-09-25 ,
Recruitment Status by Participating Study Site 2
Name of Study	Kyung Hee University Dental Hospital
Recruitment Status	Completed
Date of First Enrollment	2019-10-04 ,
Recruitment Status by Participating Study Site 3
Name of Study	VHS Medical Center
Recruitment Status	Completed
Date of First Enrollment	2019-09-23 ,

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	MedibioLAB
Organization Type	Others
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	MedibioLAB
Organization Type	Others

7. Study Summary

Study Summary Information
Lay Summary	This test was designed to evaluate the efficacy and safety of the patients with mild gum health deterioration on gum health when ingesting MAEC (a complex such as mangosteen extract) compared to the control group (placebo). Although gingivitis and periodontal disease are the most common diseases of the Korean people, except for acute bronchitis, products that are currently known as representative periodontal disease treatments do not actually have a direct effect on periodontal disease, but are merely supplements. Reports follow one after another. Therefore, in order to compensate for the limitations of surgical treatment and the problem of antibiotic use in the treatment of periodontal disease, and to improve the effect of preventing and treating periodontal disease, the chemical mediator of inflammation is controlled to control the inflammatory response and inhibit bone resorption. The need for alternative materials that can be used is increasing. In the group fed a complex consisting of 1 μg/ml mangosteen and 34 μg/ml propolis extract among mice that induced inflammation in gingival tissue, inflammation mediators (PGE2, iNOS, MMP-8, IL-8, COX-1, It was confirmed that the expression level of COX-2) was significantly suppressed, and the effect of inhibiting alveolar bone absorption was shown. These results suggest that the combination of mangosteen extract and propolis extract is an anti-inflammatory substance and may be helpful in the prevention and treatment of periodontal disease. Therefore, in this human application test, the efficacy and safety of 8 weeks of ingestion of MAEC (Mangosteen Extractive Complex) on the improvement of gum health in patients with mild gum health decreases.

Study Summary Information

Lay Summary

This test was designed to evaluate the efficacy and safety of the patients with mild gum health deterioration on gum health when ingesting MAEC (a complex such as mangosteen extract) compared to the control group (placebo).
Although gingivitis and periodontal disease are the most common diseases of the Korean people, except for acute bronchitis, products that are currently known as representative periodontal disease treatments do not actually have a direct effect on periodontal disease, but are merely supplements. Reports follow one after another.
Therefore, in order to compensate for the limitations of surgical treatment and the problem of antibiotic use in the treatment of periodontal disease, and to improve the effect of preventing and treating periodontal disease, the chemical mediator of inflammation is controlled to control the inflammatory response and inhibit bone resorption. The need for alternative materials that can be used is increasing.
In the group fed a complex consisting of 1 μg/ml mangosteen and 34 μg/ml propolis extract among mice that induced inflammation in gingival tissue, inflammation mediators (PGE2, iNOS, MMP-8, IL-8, COX-1, It was confirmed that the expression level of COX-2) was significantly suppressed, and the effect of inhibiting alveolar bone absorption was shown. These results suggest that the combination of mangosteen extract and propolis extract is an anti-inflammatory substance and may be helpful in the prevention and treatment of periodontal disease.
Therefore, in this human application test, the efficacy and safety of 8 weeks of ingestion of MAEC (Mangosteen Extractive Complex) on the improvement of gum health in patients with mild gum health decreases.

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	Supportive Care
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Others (health functional food)
Intervention Description	Once a day, 1 capsule at a time with sufficient water The intervention group consumed 194mg per day as a complex such as mangosteen extract. The control group had the same appearance and formulation, but did not contain mangosteen extract, and ingested in the same way as the test group.
Number of Arms	2
Arm 1	Arm Label Experimental
	Target Number of Participant 50
	Arm Type Experimental
	Arm Description Once a day, 1 capsule at a time with sufficient water
Arm 2	Arm Label Placebo
	Target Number of Participant 50
	Arm Type Placebo comparator
	Arm Description Once a day, 1 capsule at a time with sufficient water

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (K00-K93)Diseases of the digestive system (K06.9)Disorders of gingiva and edentulous alveolar ridge, unspecified people with mild gingival problems
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~75Year
	Description 1.Men and women 20 years old or older and 75 years old or younger 2. Those with more than 10% BOP (Bleeding on Probing) site and one or more teeth with PD (Probing Depth) greater than 3mm and less than 5mm 3. Those with at least 18 existing natural teeth 4. Those who signed the Informed Consent Form before the start of this clinical trial
Exclusion Criteria	1. Those who received scaling treatment and prophylactic periodontal treatment within 3 months of visit 1 2. Persons with a history of bleeding or disease, or taking antiplatelet drugs or anticoagulants to prevent them 3. Those with serious pathological findings on the soft tissues in the oral cavity (such as oral cancer patients) 4. Those who have 5 or more teeth to be treated for dental caries immediately 5. Patients with periodontitis requiring surgery or acute treatment 6. smoker 7. Those who took antibiotics within 2 weeks of visit 1 8. Patients with uncontrolled diabetes (fasting blood sugar greater than 180 mg/dl) 9. Those whose AST(GOT) or ALT(GPT) is more than 3 times the upper limit of the laboratory 10. Creatinine is more than twice the upper limit of the laboratory 11. Those with clinically significant cardiovascular, immune system, infectious, and neoplastic diseases 12. People with mental illness such as schizophrenia, depression, drug addiction, alcoholism, etc. 13. Those who are allergic to the main ingredients of the test food 14. Those who are pregnant or plan to become pregnant during this clinical trial, and those who are lactating 15. Those who have participated in other clinical trials within 1 month of visit 1 or plan to participate during the clinical trial period 16. A person who judges that the tester is inappropriate for this clinical trial
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	Efficacy
Outcome	GI(Gingival Index)
Timepoint	2week, 4week, 8week
Secondary Outcome(s) 1
Outcome	PD(Probing Depth)
Timepoint	baseline, 2week, 4week, 8week
Secondary Outcome(s) 2
Outcome	CAL(Clinical Attachment Level)
Timepoint	baseline, 2week, 4week, 8week
Secondary Outcome(s) 3
Outcome	PI(Plaque Index)
Timepoint	2week, 4week, 8week
Secondary Outcome(s) 4
Outcome	BOP(Bleeding on probing)
Timepoint	baseline, 2week, 4week, 8week
Secondary Outcome(s) 5
Outcome	GR(Gingival Recession)
Timepoint	baseline, 2week, 4week, 8week
Secondary Outcome(s) 6
Outcome	Biomarkers of saliva and gingival fissures(IL-1β, IL-6, MMP-8, MMP-9)
Timepoint	2week, 4week, 8week
Secondary Outcome(s) 7
Outcome	Oral Health Impact Profile-14(OHIP-14)
Timepoint	2week, 4week, 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	Yes
Time of Sharing	2021. 12
Way of Sharing	To be made available at a later date (dsl2008@naver.com)

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