Protocol summary
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Study aim
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The aim of this study is evaluation of grapeseed extract mouth wash on streptococcus mutans growth and gingival health.
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Design
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ِDental students voluntary participated to study are divided into two equal groups.By selecting the code blindly, they entered the mouthwashes and control group (water). The researcher is also unaware of the type of mouthwash and placebo and prescribes it as a code.
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Settings and conduct
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The study will be conducted in the dental faculty of Hamadan Dental Students on a three-blinded basis.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Healthy dental students with informed consent
Exclusion criteria: Systemic disease, drug use, periodontal disease and pregnancy
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Intervention groups
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Intervention group receive mouth wash containing of grapeseed extract.
Control group receive water.
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Main outcome variables
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Reduction of carious bacteria growth, gingival inflammation, plaque index and bleeding on probing.
General information
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Reason for update
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In according to reference study duration reduced from 30 days to 15 days.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191225045891N3
Registration date:
2020-03-11, 1398/12/21
Registration timing:
prospective
Last update:
2020-07-14, 1399/04/24
Update count:
1
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Registration date
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2020-03-11, 1398/12/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-04-02, 1399/01/14
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Expected recruitment end date
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2021-04-03, 1400/01/14
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of grapeseed extract mouthwash on streptococcus mutans growth and gingival health
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Public title
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The effect of grapeseed extract mouthwash on oral health
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Healthy dental students with informed consent
Exclusion criteria:
Systemic disease
Drug taking
Gingival and periodontal diseas
Pregnancy
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Age
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From 20 years old to 30 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Data analyser
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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participants, principle investigator, healthcare providers and data analyses are blinded
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-01-10, 1398/10/20
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Ethics committee reference number
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IR.UMSHA.REC.1398.882
Health conditions studied
1
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Description of health condition studied
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Gingival health
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ICD-10 code
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K02
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ICD-10 code description
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Dental caries
Primary outcomes
1
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Description
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Gingival health
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Timepoint
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Before intervention and 15 day after mouth wash using
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Method of measurement
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Observational
Secondary outcomes
1
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Description
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Plaque accumulation
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Timepoint
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efore and 1 month after intervention
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Method of measurement
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Oral disclosing tablets
Intervention groups
1
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Description
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Intervention group: 40 dental student voluntary selected and receive grapeseed extract mouth washes. Two file filled for all students. one before and one 15 day after intervention. Each persons used mouth washes 2 times a day for 1 minutes. Files consist: biographic data, bleeding on probing, gingival index and plaque accumulation
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Category
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Prevention
2
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Description
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Control group: 40 students only receive water.
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Category
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Lifestyle
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Hamedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable