UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039806 |
|---|---|
| Receipt number | 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 10:55:39 |
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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
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
ina.hendiani@fkg.unpad.ac.id
Sponsor or person
Institute
Dental Faculty - Universita Padjadjaran Bandung, West Java - Indonesia
Department of Periodontology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045396
