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General information
empty
In according to reference study duration reduced from 30 days to 15 days.
In according to reference study duration reduced from 30 days to 15 days.
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مطابق رفرنس طول مدت مطالعه از 30 روز به 15 روز کاهش یافت.
مطابق رفرنس طول مدت مطالعه از 30 روز به 15 روز کاهش یافت.
Primary outcomes
#1
Before intervention and 1 month after mouth wash using
Before intervention and 15 day after mouth wash using
Before intervention and 1 month15 day after mouth wash using
قبل از مداخله و 1 ماه بعد از مصرف دهان شویه
قبل از مداخله و 15 روز بعد از مصرف دهان شویه
قبل از مداخله و 1 ماه15 روز بعد از مصرف دهان شویه
Intervention groups
#1
Intervention group: 40 dental student voluntary selected and receive grapeseed extract mouth washes. Two file filled for all students. one before and one 30 day after intervention. Each persons used mouth washes 4 times a day for 1 minutes. Files consist: biographic data, bleeding on probing, gingival index and plaque accumulation
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
Intervention group: 40 dental student voluntary selected and receive grapeseed extract mouth washes. Two file filled for all students. one before and one 3015 day after intervention. Each persons used mouth washes 42 times a day for 1 minutes. Files consist: biographic data, bleeding on probing, gingival index and plaque accumulation
گروه مداخله: تعداد 40نفر از دانشجویان دانشگاه علوم پزشکی به صورت داوطلبانه انتخاب شده دهان شویه حاوی عصاره هسته انگور دریافت می کنند.برای هر بیمار 2 پرونده پر خواهد شد که یکی در قبل از استفاده از دهان شویه ها و دیگری بعد از استفاده 30روزه از دهان شویه ها خواهد بود .هر فرد روزانه 4 بار از دهان شویه را به مدت 1 دقیقه استفاده خواهد کرد . پرونده شامل سؤالات بیوگرافی از بیمار ، خونریزی لثه ، شاخص لثه ای، جرم و پلاک است.
گروه مداخله: تعداد 40نفر از دانشجویان دانشگاه علوم پزشکی به صورت داوطلبانه انتخاب شده دهان شویه حاوی عصاره هسته انگور دریافت می کنند.برای هر بیمار 2 پرونده پر خواهد شد که یکی در قبل از استفاده از دهان شویه ها و دیگری بعد از استفاده 15روزه از دهان شویه ها خواهد بود .هر فرد روزانه 2 بار از دهان شویه را به مدت 1 دقیقه استفاده خواهد کرد . پرونده شامل سؤالات بیوگرافی از بیمار ، خونریزی لثه ، شاخص لثه ای، جرم و پلاک است.
گروه مداخله: تعداد 40نفر از دانشجویان دانشگاه علوم پزشکی به صورت داوطلبانه انتخاب شده دهان شویه حاوی عصاره هسته انگور دریافت می کنند.برای هر بیمار 2 پرونده پر خواهد شد که یکی در قبل از استفاده از دهان شویه ها و دیگری بعد از استفاده 30روزه15روزه از دهان شویه ها خواهد بود .هر فرد روزانه 42 بار از دهان شویه را به مدت 1 دقیقه استفاده خواهد کرد . پرونده شامل سؤالات بیوگرافی از بیمار ، خونریزی لثه ، شاخص لثه ای، جرم و پلاک است.
Protocol summary
Study aim
The aim of this study is evaluation of grapeseed extract mouth wash on streptococcus mutans growth and gingival health.
Design
ِ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.
Settings and conduct
The study will be conducted in the dental faculty of Hamadan Dental Students on a three-blinded basis.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Healthy dental students with informed consent
Exclusion criteria: Systemic disease, drug use, periodontal disease and pregnancy
Intervention groups
Intervention group receive mouth wash containing of grapeseed extract.
Control group receive water.
Main outcome variables
Reduction of carious bacteria growth, gingival inflammation, plaque index and bleeding on probing.
General information
Reason for update
In according to reference study duration reduced from 30 days to 15 days.
Acronym
IRCT registration information
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
Registration date
2020-03-11, 1398/12/21
Registrant information
Name
Fatemeh Ahmadi-Motamayel
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1059
Email address
f.ahmadi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-02, 1399/01/14
Expected recruitment end date
2021-04-03, 1400/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of grapeseed extract mouthwash on streptococcus mutans growth and gingival health
Public title
The effect of grapeseed extract mouthwash on oral health
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy dental students with informed consent
Exclusion criteria:
Systemic disease
Drug taking
Gingival and periodontal diseas
Pregnancy
Age
From 20 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
participants, principle investigator, healthcare providers and data analyses are blinded
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamadan University of Medical Sciences
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838677
Approval date
2020-01-10, 1398/10/20
Ethics committee reference number
IR.UMSHA.REC.1398.882
Health conditions studied
1
Description of health condition studied
Gingival health
ICD-10 code
K02
ICD-10 code description
Dental caries
Primary outcomes
1
Description
Gingival health
Timepoint
Before intervention and 15 day after mouth wash using
Method of measurement
Observational
Secondary outcomes
1
Description
Plaque accumulation
Timepoint
efore and 1 month after intervention
Method of measurement
Oral disclosing tablets
Intervention groups
1
Description
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
Category
Prevention
2
Description
Control group: 40 students only receive water.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan Dental School
Full name of responsible person
Fatemeh Ahmadi-Motamayel
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 1059
Email
fatahmadim@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Email
research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Ahmadi-Motamayel
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Oral Medicine.,Dental School., Hamadan University of Medical Sciences., Shahid Fahmideh Ave., Hamadan., Iran
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 1059
Fax
+98 81 3838 1085
Email
f.ahmadi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Ahmadi-Motamayel
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Oral Medicine.,Dental School., Hamadan University of Medical Sciences., Shahid Fahmideh Ave., Hamadan., Iran
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 1059
Fax
+98 81 3838 1085
Email
fatahmadim@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Ahmadi-Motamayel
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Oral Medicine.,Dental School., Hamadan University of Medical Sciences., Shahid Fahmideh Ave., Hamadan., Iran
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 1059
Fax
+98 81 3838 1085
Email
fatahmadim@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available