Clinical effect of Aloysia citriodora mouth wash on plaque-induced gingivitis compare with chlorhexidine
Design
In this phase 3 Clinical Trial, after considering the entry and exit criteria, the study subjects are randomly divided into three groups using random allocation software.
Considering the total volume of samples, 72 people , there are 24 samples in each group.
Settings and conduct
Sari dentisrty University.This clinical Trial is double blinded so the researcher and the participants have no information about the type of mouthwashes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: people who have plaque induced generalized chronic gingivitis;
not having systemic disease;
not using antibiotics in last 3 months;
not having known allergies to lippia cotriodora plant;
not using drugs affecting periodontum directly.
Exclusion criteria:
smoking;
pregnant women;
those who have received periodontal treatment in last 3 months.
Intervention groups
The first group will receive Lippia citriodora mouthwash, The second group will receive chlorhexidine mouthwash and placebo will be given to third group.
Main outcome variables
Gingival index - plaque index - bleeding on probing- mouthwash rinse
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190117042392N1
Registration date:2019-02-26, 1397/12/07
Registration timing:prospective
Last update:2019-02-26, 1397/12/07
Update count:0
Registration date
2019-02-26, 1397/12/07
Registrant information
Name
Dorsa Giahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3324 3228
Email address
dorsagiahi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-09, 1398/01/20
Expected recruitment end date
2019-06-10, 1398/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical effect of Aloysia citriodora mouth wash on plaque-induced gingivitis compare with chlorhexidine
Public title
Clinical effect of Aloysia citriodora mouth wash on plaque-induced gingivitis compare with chlorhexidine
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
people who have plaque induced generalized chronic gingivitis.
not having systemic disease.
not using antibiotics in last 3 months.
not having known allergies to lippia cotriodora plant .
not using drugs affecting periodontum directly.
Exclusion criteria:
smokers
pregnant women
those who have received periodontal treatment in last 3 months.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
After considering entry and exit criteria, Assigning samples to three groups by the means of blocking method will be done.So there will be 12 blocks of 6 with the use of Random allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and the participant are not aware of the type of mouthwashes and do not know in which group participants are assigned.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran university of medical sciences
Street address
Khazar Blvd.Sea road17 km. Mazandaran unicersity of medical sciences.Sari city
City
Sari
Province
Mazandaran
Postal code
48157-33971
Approval date
2019-02-23, 1397/12/04
Ethics committee reference number
IR.MAZUMS.REC.1397.273
Health conditions studied
1
Description of health condition studied
Plaque induced gingivitis
ICD-10 code
k05.1
ICD-10 code description
Chronic gingivitis
Primary outcomes
1
Description
Changes in gingival index, plaque index and bleeding upon probing
Timepoint
At the beginning of the study, first and third weeks
Method of measurement
Observation and probing
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group one: lippia citriodora mouthwash made from its extract will be rinsed twice a day each time 30 seconds 10 ml for 2 weeks. The patient will be trained not to eat or drink 30 minutes after using the mouthwash. Correct method of brushing and oral hygiene will be trained to patients.
Category
Treatment - Drugs
2
Description
Intervention group two: normal saline as placebo will be given to this group in dark bottles. patients will be instructed to rinse the mouthwash twice a day each time 30 seconds 10 ml for 2 weeks. The patient will be instructed not to eat or drink 30 minutes after the use of mouthwash. Correct form of brushing and oral hygiene will be instructed to patients.
Category
Treatment - Drugs
3
Description
Control group: chlorhexidine mouthwash 0.2% (Behsa productions) will be poured in dark bottles and given to patients. Patients will be instructed to rinse the mouthwash twice a day each time 30 seconds 10 ml for 2 weeks. Patient will be instructed not to eat or drink 30 minutes after the use of mouthwash. Correct form of brushing and oral hygiene will be instructed to patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sari Dental School
Full name of responsible person
Hodis Ehsani
Street address
Sari Dental Clinic, Khazar Blvd.
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 4894
Email
hodis_ehsani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeedi
Street address
Khazar Blvd. dental school and clinic of Sari
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 4894
Email
dorsagiahi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Hodis Ehsani
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Khazar Blvd. Sari dental school
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 4014
Email
hodisehsani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Hodis Ehsani
Position
assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Khazar Blvd. Sari dental school
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 4894
Email
hodis_ehsani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Hodis Ehsani
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Khazar Blvd. Sari Dental school
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 4894
Email
hodis_ehsani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
the complete information of patients can be accessed in anytime after protocol . letter of satisfication and ethic codes are written in the project.
When the data will become available and for how long
after the results
To whom data/document is available
researchers
Under which criteria data/document could be used
researchers who want to do experimental studies related to this subject
From where data/document is obtainable
Email
What processes are involved for a request to access data/document
after sending Email and describtions about his/her work can expect the answer few weeks later.