UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of guava and vitamin C supplementation on experimental gingivitis. A randomized clinical trial
Title of the study (Brief title)	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	Amaliya
Organization	Dental Faculty - Universitas Padjadjaran
Division name	Department of Periodontology
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	Prof Dr Ubele van der Velden
Organization	Academisch Centrum Tandheelkunde Amsterdam
Division name	Department of Periodontology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Both guava fruit and vitamin C supplementation are beneficial in controlling experimentally induced gingival inflammation in young adults.
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