Determination of the Effect of New Herbal Mouth wash, Hasis as Adjunct Treatment in Gingivitis Patients
Design
Clinical trials with control group, double blind, number of patients: 25, phase 3
Settings and conduct
On the days 0 and 14, the examiner measured the indexes in the dentistry department's Pario section. Double blind
The patient did not know which mouthwash was measured
The analyst did not know what data was being analyzed for which mouthwash
Participants/Inclusion and exclusion criteria
Inclusion criteria:Dentistry student in shahid beheshti university with plaque induced gingivitis.
Exclusion criteria:Pregnant patient- smoking- patient with systemic disease and diabetes- unsing iron supply- orthodontics therapy
Intervention groups
There were two samples in each patient (the study was cross-over and randomly assigned a mouthwash to be given at first to each group, in the second stage mouthwashes have changed)
1 - Intake of mouthwash 2 - Intake of chlorhexidine
On Day 0, the indexes are measured and the first mouthwash is given to the patient, then the indices associated with the first mouthwash are measured on day 14, then the patient does not use any mouthwash for 2 weeks, then the second mouthwash is given to the patient. And the indicators are measured at days 0 and 14
Main outcome variables
Bleeding on probing. Gingival index. Peridontal Probing Depth.plaque index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180131038572N1
Registration date:2019-01-24, 1397/11/04
Registration timing:retrospective
Last update:2019-01-24, 1397/11/04
Update count:0
Registration date
2019-01-24, 1397/11/04
Registrant information
Name
Atiyeh Farahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2283 7194
Email address
atiyehfarahi1993@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-06, 1396/06/15
Expected recruitment end date
2018-09-06, 1397/06/15
Actual recruitment start date
2018-09-06, 1397/06/15
Actual recruitment end date
2018-12-21, 1397/09/30
Trial completion date
2018-12-21, 1397/09/30
Scientific title
Evaluation of the effectiveness of new herbal mouthwash,Hasis on periodontal indices in patients with plaque induced gingivitis: clinical trial
Public title
Evaluation of herbal mouthwah, Hasis on plaque induced gingivitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Dentistry student in shahid beheshti university with plaque induced gingivitis
Exclusion criteria:
Pregnant patient
smoking
patient with systemic disease and diabetes
unsing iron supply
orthodontics therapy
Age
From 20 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
25
More than 1 sample in each individual
Number of samples in each individual:
2
using Hasis and chlorhexidine mothwash,cross over
Actual sample size reached:
25
More than 1 sample in each individual
Actual sample size in each individual:
2
using Hasis and chlorhexidine mothwash,cross over
Randomization (investigator's opinion)
Randomized
Randomization description
Using the coin method, the subjects were divided into two groups A and B, Group, and accordingly, the mouthwash was first assigned to each group.Then, in the second stage, by cross over method mouthwashes have changed.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient did not know which mouthwash was used
Mouthwashes were blown in opaque bottles of the same type, labeled A and B, Hasis was flavored with mint (Mint did not have a curative effect on the mouthwash, it was purely flavoring), resulting in a great deal of taste with chlorhexidine.
The analyst did not know what data was being analyzed for which mouthwash
Data was provided to the analyzer in the form of mouthwash data A and mouthwash data B.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid beheshti Dental School
Street address
Shahid Behest Dental School, Velenjak St. , Shahid Chamran Highway,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2017-12-19, 1396/09/28
Ethics committee reference number
IR.SBMU.RIDS.REC.1396.553
Health conditions studied
1
Description of health condition studied
plaque induced gingivitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
periodontal probing depth
Timepoint
On days 0 and 7, use mouthwash
Method of measurement
Measure the gap between the gingival edge to the depth of the envelope by Williams Probe
2
Description
bleeding on probing
Timepoint
On days 0 and 7, use mouthwash
Method of measurement
The presence or absence of bleeding after examination with the Williams probe by observation
3
Description
plaque index
Timepoint
On days 0 and 7, use mouthwash
Method of measurement
The colored surfaces visible after application of the detector solution. o'leary index: number of painted surfaces based on the presence of plaque / number of checked levels x100
4
Description
Gingival Index
Timepoint
On days 0 and 7, use mouthwash
Method of measurement
By Observation and probing
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Mouthwash Formulated by Shahid Beheshti Pharmaceutical Faculty. Using for 2 weeks. Once upon a time 2 times. For 1 minute 30 minutes after brushing in the morning and night
Category
Treatment - Drugs
2
Description
Intervention group:Chlorhexidine consumption is 0.2%. Cross-over, Consume for 2 weeks. Once upon a time 2 times. For 1 minute 30 minutes after brushing in the morning and night
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pario section ,Shahid Beheshti Dental School
Full name of responsible person
Dr Mohammadreza Talebi
Street address
Shahid Behest Dental School, Velenjak St. , Shahid Chamran Highway,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9982
Fax
+98 21 2243 9784
Email
Intl_office@sbmu.ac.ir
Web page address
http://dentistry.sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Safavi
Street address
Shahid Behest Dental School, Velenjak St. , Shahid Chamran Highway,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9982
Fax
+98 21 2243 9784
Email
Intl_office@sbmu.ac.ir
Web page address
http://dentistry.sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammadreza Talebi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department Of Periodontics, Shahid Behest Dental School, Velenjak St. , Shahid Chamran Highway,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9982
Fax
+98 21 2243 9784
Email
Intl_office@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammadreza Talebi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department Of Periodontics,Shahid Behest Dental School, Velenjak St. , Shahid Chamran Highway,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9982
Email
Intl_office@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azalea Esmaelnejad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Periodontics ,Shahid Behest Dental School, Velenjak St. , Shahid Chamran Highway,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9982
Email
esmaeilnejada@yahoo.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