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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031772
Receipt No. R000036270
Scientific Title Effect of guava and vitamin C supplementation on experimental gingivitis. A randomized clinical trial
Date of disclosure of the study information 2018/03/17
Last modified on 2018/03/17

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Basic information
Public title Effect of guava and vitamin C supplementation on experimental gingivitis.
A randomized clinical trial
Acronym Guava and vitamin C suplementation on experimental gingivitis
Scientific Title Effect of guava and vitamin C supplementation on experimental gingivitis.
A randomized clinical trial
Scientific Title:Acronym Guava and vitamin C suplementation on experimental gingivitis
Region
Asia(except Japan)

Condition
Condition Non-smoker healthy young population
Classification by specialty
Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the effect of guava and synthetic vitamin C on the development of gingival inflammation during experimental gingivitis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Gingival inflammation during exprimental gingivitis
Key secondary outcomes Plaque accumulation during experimental gingivitis

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Guava fruit including skin and flesh, 200 gr/day for 28 days
Interventions/Control_2 Synthetic Vitamin C, 200 mg/day for 28 days
Interventions/Control_3 Water, packed in cup of 250 ml/day, for 28 days
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
18 years-old <=
Age-upper limit
25 years-old >=
Gender Male and Female
Key inclusion criteria healthy adult, non-smokers, no probing pocket depth more than 4 mm at any site and bleeding on probing less than 10%.
Key exclusion criteria (1) having systemic diseases, (2) being pregnant or giving breastfeeding, (3) having physical or mental handicaps that may interfere with an adequate oral hygiene, (4) having a history of drug abuse, (5) using nonsteroidal or steroidal anti-inflammatory drugs, analgesic or antibiotics within 6 weeks before the study, (7) having untreated carious lesions, crowns or orthodontic appliances in the lower jaw.
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Amaliya
Organization Dental Faculty - Universitas Padjadjaran
Division name Department of Periodontology
Zip code
Address Jalan Sekeloa Selatan no. 1 Bandung 40132 West Java - Indonesia
TEL +62222533044
Email amaliya@fkg.unpad.ac.id

Public contact
Name of contact person
1st name
Middle name
Last name Prof Dr Ubele van der Velden
Organization Academisch Centrum Tandheelkunde Amsterdam
Division name Department of Periodontology
Zip code
Address Gustav Mahlerlaan 3004, 1081 LA Amsterdam, The Netherlands
TEL +31205980380
Homepage URL https://www.acta.nl/en/
Email u.vd.velden@acta.nl

Sponsor
Institute Dental Faculty - Universitas 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
Address
Tel
Email

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 Universitas Padjadjaran" (Bandung, West Java - Indonesia)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 17 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
Both guava fruit and vitamin C supplementation are beneficial in controlling experimentally induced gingival inflammation in young adults.  
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 Completed
Date of protocol fixation
2016 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
2017 Year 05 Month 01 Day
Date of closure to data entry
2017 Year 05 Month 30 Day
Date trial data considered complete
2017 Year 06 Month 05 Day
Date analysis concluded
2017 Year 11 Month 05 Day

Other
Other related information The data support the hypothesis that consumption of fruits high in vitamin C may be helpful in the prevention of gingivitis.

Management information
Registered date
2018 Year 03 Month 17 Day
Last modified on
2018 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036270

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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