Protocol summary
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Study aim
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Comparing the effect of Dental Flosses cotaining Fluoride, Benzydamine and Aloe vera on Periodontal Indexes in Gingivitis
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Modified Gingival Index (MGI)
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2019-11-25, 1398/09/04
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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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2019-04-19, 1398/01/30
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Expected recruitment end date
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2019-07-21, 1398/04/30
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Actual recruitment start date
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2019-04-19, 1398/01/30
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Actual recruitment end date
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2019-07-21, 1398/04/30
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Trial completion date
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2019-07-21, 1398/04/30
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Scientific title
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Comparing the effect of Dental Flosses cotaining Fluoride, Benzydamine and Aloe vera on Periodontal Indexes in Gingivitis
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Public title
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Comparing the effect of Dental Flosses cotaining Fluoride, Benzydamine and Aloe vera on Periodontal Indexes in Gingivitis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
20-50 years old
gingivitis
No smoking
Exclusion criteria:
Patients with orthodontic treatment
Patients with hypertension or diabetes
Patients taking immunomodulatory drugs
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Age
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From 20 years old to 50 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
45
Actual sample size reached:
45
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not 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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2019-04-13, 1398/01/24
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Ethics committee reference number
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IR.GUMS.REC.1398.010
Health conditions studied
1
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Description of health condition studied
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Gingivitis
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ICD-10 code
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K05.1
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ICD-10 code description
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Chronic gingivitis
Primary outcomes
1
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Description
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Modified Gingival Index (MGI)
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Timepoint
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At the beginning of study, seventh day and fourteenth day
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Method of measurement
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Observation and Evaluation
Intervention groups
1
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Description
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Intervention group 1 : Marjan's No Wax Dental floss, containing fluoride for each patient once a day for one week.
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Category
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Treatment - Devices
2
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Description
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Intervention group 2 : Marjan's No Wax Dental floss, containing aloe vera for each patient once a day for one week.
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Category
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Treatment - Devices
3
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Description
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Intervention group 2 : Marjan's No Wax Dental floss, containing Benzydamine for each patient once a day for one week.
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Category
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Treatment - Devices
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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Rasht 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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Undecided - It is not yet known if there will be a plan to make this available
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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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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available