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Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hani Naderi
Full name of responsible person - Persian: هانی نادری
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: specialist
Area of specialty/work: 43
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Guilan Dental Clinic,Opposite of Pardis Hotel, Imam Khomeini Ave.
Street address - Persian: خیابان امام خمینی، روبروی هتل پردیس، کلینیک دندان پزشکی
City - English: Rasht
City - Persian: رشت
Province: Guilan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 4188794755
Phone: +98 13 3348 6406
Mobile: +98 912 324 0991
Fax:
Email: haninaderi@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Arash ghafoori
Full name of responsible person - Persian: آرش غفوری
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: specialist
Area of specialty/work: 43
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Guilan Dental Clinic,Opposite of Pardis Hotel, Imam Khomeini Ave.
Street address - Persian: خیابان امام خمینی، روبروی هتل پردیس، کلینیک دندان پزشکی
City - English: Rasht
City - Persian: رشت
Province: Guilan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 4188794755
Phone: +98 13 3348 6406
Mobile: +98 912 324 0991
Fax:
Email: arashghafori@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Hani NaderiArash ghafoori Full name of responsible person - Persian: هانی نادریآرش غفوری Position - English: Assistant Professor Position - Persian: استادیار Latest degree: specialist Area of specialty/work: 43 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Guilan Dental Clinic,Opposite of Pardis Hotel, Imam Khomeini Ave. Street address - Persian: خیابان امام خمینی، روبروی هتل پردیس، کلینیک دندان پزشکی City - English: Rasht City - Persian: رشت Province: Guilan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 4188794755 Phone: +98 13 3348 6406 Mobile: +98 912 324 0991 Fax: Email: haninaderiarashghafori@yahoo.com Web page address:
Protocol summary
Study aim
Comparing the effect of Dental Flosses cotaining Fluoride, Benzydamine and Aloe vera on Periodontal Indexes in Gingivitis
Design
In this clinical trial study, the sample size will be determined using the previous articles, considering the 95% confidence level, 15 individuals in each group. Patients with gingivitis and those with inclusion criteria who referred to the Dental Clinic of Rasht will be selected. Participants will randomly divided into three intervention groups: one, two, and three based on a random number table.
Settings and conduct
This study will be conducted in Dental Clinic of Rasht. Patients will be entered into the study after obtaining informed consent regarding the inclusion and exclusion criteria and will be randomly divided into three groups. In the first intervention group, Marjan's No Wax Dental floss, containing fluoride , in the second group, Marjan's No Wax Dental floss, containing aloe vera and in the third group Marjan's No Wax Dental floss, containing benzidamine will be used for each patient once a day for one week,. The modified gingival index will be evaluated at the beginning of the study, on days 7 and 14, by examination and observation.
Participants/Inclusion and exclusion criteria
major inclusin and exclusion criteria: Patients Aged over 20-50 years, with gingivitis and No history of smoking were included; Patients who have orthodontic treatment, Patients with hypertension or diabetes or taking immunomodulatory drugs were excluded
Intervention groups
In the first intervention group, Marjan's No Wax Dental floss, containing fluoride , in the second group, Marjan's No Wax Dental floss, containing aloe vera and in the third group Marjan's No Wax Dental floss, containing benzidamine will used for each patient once a day for one week.
Main outcome variables
Modified Gingival Index (MGI)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191026045248N1
Registration date:2019-11-25, 1398/09/04
Registration timing:retrospective
Last update:2020-01-05, 1398/10/15
Update count:1
Registration date
2019-11-25, 1398/09/04
Registrant information
Name
Naser Jurebrahimiyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3348 6418
Email address
jurnaser@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-19, 1398/01/30
Expected recruitment end date
2019-07-21, 1398/04/30
Actual recruitment start date
2019-04-19, 1398/01/30
Actual recruitment end date
2019-07-21, 1398/04/30
Trial completion date
2019-07-21, 1398/04/30
Scientific title
Comparing the effect of Dental Flosses cotaining Fluoride, Benzydamine and Aloe vera on Periodontal Indexes in Gingivitis
Public title
Comparing the effect of Dental Flosses cotaining Fluoride, Benzydamine and Aloe vera on Periodontal Indexes in Gingivitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20-50 years old
gingivitis
No smoking
Exclusion criteria:
Patients with orthodontic treatment
Patients with hypertension or diabetes
Patients taking immunomodulatory drugs
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
45
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will used by the blocking method. For this purpose, letter A represents the first intervention group and letter B represents the second intervention group and letter C represents the third intervention group and two pattern will assumed ABC and CBA; If in Random number table, the even numbers come out ABC will used and if the odd one comes CBA will used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Opposite 17 Shahrivar Hospital, Shahid Siadati Ave., Namjoo Street Ave.
City
Rasht
Province
Guilan
Postal code
4188794755
Approval date
2019-04-13, 1398/01/24
Ethics committee reference number
IR.GUMS.REC.1398.010
Health conditions studied
1
Description of health condition studied
Gingivitis
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis
Primary outcomes
1
Description
Modified Gingival Index (MGI)
Timepoint
At the beginning of study, seventh day and fourteenth day
Method of measurement
Observation and Evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 : Marjan's No Wax Dental floss, containing fluoride for each patient once a day for one week.
Category
Treatment - Devices
2
Description
Intervention group 2 : Marjan's No Wax Dental floss, containing aloe vera for each patient once a day for one week.
Category
Treatment - Devices
3
Description
Intervention group 2 : Marjan's No Wax Dental floss, containing Benzydamine for each patient once a day for one week.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasht Dental Clinic
Full name of responsible person
Hani Naderi
Street address
Guilan Dental Clinic,Opposite of Pardis Hotel, Imam Khomeini Ave.
City
Rasht
Province
Guilan
Postal code
4188794755
Phone
+98 13 3348 6406
Email
Haninaderi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Reza Naghipor
Street address
Vice Chancellor for Research and Technology, Opposite 17 Shahrivar Hospital, Shahid Siadati Ave., Namjoo Street Ave.
City
Rasht
Province
Guilan
Postal code
4188794755
Phone
+98 13 3333 5821
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Naser Jurebrahimiyan
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Guilan Dental Clinic,Opposite of Pardis Hotel, Imam Khomeini Ave.
City
Rasht
Province
Guilan
Postal code
4188794755
Phone
+98 13 3348 6418
Fax
Email
Jurnaser@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Arash ghafoori
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Guilan Dental Clinic,Opposite of Pardis Hotel, Imam Khomeini Ave.
City
Rasht
Province
Guilan
Postal code
4188794755
Phone
+98 13 3348 6406
Email
arashghafori@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Naser Jurebrahimiyan
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Guilan Dental Clinic,Opposite of Pardis Hotel, Imam Khomeini Ave.
City
Rasht
Province
Guilan
Postal code
4188794755
Phone
+98 13 3348 6418
Fax
Email
Jurnaser@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available