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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039806
Receipt No. R000045396
Scientific Title Effectiveness of mangosteen (Garcinia mangostana L.) extract gel on the MMP-8 levels in chronic periodontitis patients after scaling and root planing
Date of disclosure of the study information 2020/03/13
Last modified on 2020/03/13

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Basic information
Public title Effectiveness of mangosteen (Garcinia mangostana L.) extract gel on the MMP-8 levels in chronic periodontitis patients after scaling and root planing
Acronym mangosteen extract gel on the MMP-8 levels in chronic periodontitis patients
Scientific Title Effectiveness of mangosteen (Garcinia mangostana L.) extract gel on the MMP-8 levels in chronic periodontitis patients after scaling and root planing
Scientific Title:Acronym mangosteen extract gel on the MMP-8 levels in chronic periodontitis patients
Region
Asia(except Japan)

Condition
Condition periodontitis patients
Classification by specialty
Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to determined the effect of mangosteen peel extract gel on MMP-8 levels in the gingival crevicular fluid of chronic periodontitis patients after scaling and root planing
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes periodontal inflammation during experimental periodontitis
Key secondary outcomes MMP-8 levels during experimental periodontitis

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 skeling root planing and mangosteen extract gel on day 1st and 7th
Interventions/Control_2 skeling root planing
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
30 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria adult chronic periodontitis with pocket depth 5-7 mm, have not received periodontal treatment for the past 6 months, have no systemic conditions
Key exclusion criteria use any prosthesis and orthodontic devices, and not taking antibiotics and mouthwash for the past 3 months
Target sample size 32

Research contact person
Name of lead principal investigator
1st name ina
Middle name
Last name hendiani
Organization dental faculty - universitas padjadjaran
Division name department of periodontology
Zip code 40132
Address jalan sekeloa selatan no. 1 Bandung west java - Indonesia
TEL +62222533044
Email ina.hendiani@fkg.unpad.ac.id

Public contact
Name of contact person
1st name ina
Middle name
Last name hendiani
Organization dental faculty - universitas padjadjaran
Division name department of periodontology
Zip code 40132
Address jalan sekeloa selatan no. 1 Bandung west java - Indonesia
TEL +62222533044
Homepage URL
Email ina.hendiani@fkg.unpad.ac.id

Sponsor
Institute Dental Faculty - Universita Padjadjaran Bandung, West Java - Indonesia
Department of Periodontology
Institute
Department

Funding Source
Organization self-funding by author
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization dental faculty - universitas padjadjaran
Address jalan sekeloa selatan no. 1 Bandung west java - Indonesia
Tel +62222533044
Email ina.hendiani@fkg.unpad.ac.id

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 "Rumah Sakit Gigi dan Mulut (Dental Hospital) Dental Faculty Univesitas Padjadjaran" (Bandung, West Java - Indonesia"

Other administrative information
Date of disclosure of the study information
2020 Year 03 Month 13 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 32
Results
Application of the mangosteen peel extract gel as the adjuvant therapy after scaling and root planing treatment in chronic periodontitis patients had no significant effect on decreasing the MMP-8 levels. However, there was a higher decrease in the MMP-8 levels in the group administered with the mangosteen peel extract gel.
Results date posted
2020 Year 03 Month 13 Day
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
2019 Year 02 Month 06 Day
Date of IRB
2019 Year 03 Month 19 Day
Anticipated trial start date
2019 Year 08 Month 08 Day
Last follow-up date
2019 Year 10 Month 14 Day
Date of closure to data entry
2019 Year 11 Month 01 Day
Date trial data considered complete
2019 Year 11 Month 06 Day
Date analysis concluded
2019 Year 12 Month 15 Day

Other
Other related information the data support the hypothesis that mangosteen peel have anti inflammation effect

Management information
Registered date
2020 Year 03 Month 13 Day
Last modified on
2020 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045396

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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