Fruit of Zenian (Trachyspermum ammi) will be used to extract essential oil of the plant using hydrodistillation method by Clevenger type apparatus. Subsequently, composition of the oil will be identified to prepare the mouthwash. Co-solvents including propylene glycol and/or glycerin will be used to prepare stable mouthwash. Stability in use of the prepared mouthwash will be evaluated as well. The mouthwash will be used in patients who suffers from gingivitis for 2 weeks and gingivitis index in the treatment group will be compared with group of positive control (chlorhexidine mouthwash).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062022833N1
Registration date:2015-07-18, 1394/04/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-07-18, 1394/04/27
Registrant information
Name
Azadeh Manayi
Name of organization / entity
Medicinal Plants Research Center, Faculty of Pharmacy, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6412 1202
Email address
manayi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of effect of Zenian oil (Trachyspermum ammi) mouthwash in gingivitis and comparison with chlorhexidine mouthwash
Public title
Effect of Zenian mouthwash on gingivitis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patient with inflammation and bleeding gums trough flossing or brushing
Exclusion criteria: Patient withdrawal; Periodontitis; Attachment loss
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Tehran University of Medical Sciences
Street address
Ethics Committee, Tehran University of Medical Sciences, Ghods Street, Enghelab Square, Tehran, Iran
City
Tehran
Postal code
Approval date
2015-06-17, 1394/03/27
Ethics committee reference number
8823120003
Health conditions studied
1
Description of health condition studied
Gingivitis
ICD-10 code
K05
ICD-10 code description
Gingivitis and periodontal diseases
Primary outcomes
1
Description
Inflammation
Timepoint
14 days
Method of measurement
Clinical investigation by a periodontics
2
Description
Gum bleeding
Timepoint
14 days
Method of measurement
Clinical inevstigation by a periodontics
Secondary outcomes
1
Description
Enduring of the taste of the herbal mouthwash
Timepoint
After 2 weeks
Method of measurement
Inquiring of patients
Intervention groups
1
Description
Removing of dental plaques and subsequently application of mouthwash of chlorhexidine two times a day each time 5 mL for 2 weeks
Category
Treatment - Drugs
2
Description
Removing of dental plaques and subsequently application of mouthwash of Zenian 2 times a day each time 5 mL for 2 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Medical Sciences
Full name of responsible person
Dr. Anna Safarpoor
Street address
Faculty of Dentistry, Energy Street, North Kargar Street, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ms. Khoshtarkib
Street address
Tehran University of Medical Sciences, Keshavarz Blovard, Ghods Street
City
Tehran
Grant name
Grant code / Reference number
8823120003
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Medicinal Plants Research Center, Faculty of Pharmacy, Tehran University of Medical Sciences
Full name of responsible person
Dr. Azadeh Manayi
Position
Assisatnt Profesor
Other areas of specialty/work
Street address
Faculty of Pharmacy, 16 Azar Street, Enghelab Square,Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6412 1202
Fax
Email
manayi@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medicianl Plants Research Center
Full name of responsible person
Dr. Azadeh Manayi
Position
Pharmacognosy, Ph.D.
Other areas of specialty/work
Street address
Faculty of Pharmacy, 16 Azar Street, Enghelab Square, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6412 1202
Fax
Email
manayi@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medicinal Plants Research Center
Full name of responsible person
Dr. Azadeh Manayi
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Pharmacy, 16 Azar Street, Enghelab Square, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6412 1202
Fax
+98 21 6412 1229
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)