Protocol summary

Summary
The aim of this study is to evaluation of in vitro and in vivo antimicrobial effects of herbal mouthwash to form effervescent tablet and herbal toothpaste containing the extracts of Artemisia dracunculus, Satureja khuzestanica and Myrtus communis against oral pathogenic microorganisms (Streptococcus sanguinis, Streptococcu salivarious, Streptococcu mutans and Candida albicans). This study is clinical trial without control (Before & After) that will be perform on 40 girl students volunteers aging 20-25 years, healthy with normal gums without bleeding or inflammation. Exclusion criteria: periodontal diseases; usage of antibiotic; antifungal and corticosteroid drugs in the recent three months. Twenty volunteers will be given herbal toothpaste and asking from them at 12 o’clock midnight to wash their mouths by 10-15ml deionized water for one minute, pour the contents of their mouth into sterile container as samples of before test. Then will be asked them to use brushing their teeth with herbal toothpaste. Six hours after applying herbal toothpaste, the next morning again will be asked from same volunteers to wash their mouths by 10-15 ml deionized water for one minute and pour the contents of their mouth into another sterile container as sample of after test. Then the samples transfer to laboratory immediately. Aliquots of 100µl of each sample inoculate on petri dishes containing blood agar for bacteria and Sabouraud dextrose agar medium for Candida albicans. Plates were incubated inside of an anaerobic jar with 5-7 CO2 concentration at 35-37°c for 24 hours (Bacteria) and 48 hours (fungi). Then colonies will be count before and after test, separately. This process will be repeat for the herbal effervescent granule mouthwash by other 20 volunteers with same condition.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015112825240N2
Registration date: 2016-01-22, 1394/11/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-01-22, 1394/11/02
Registrant information
Name
Batool Sadeghi Nejad
Name of organization / entity
Abadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 5326 5361
Email address
sadeghi-b@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Abadan. University of Medical SciencesVice chancellor for research: Dr. Mohammad Mahboby
Expected recruitment start date
2015-12-01, 1394/09/10
Expected recruitment end date
2016-01-30, 1394/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preparation of mouthwash and toothpaste containing the extracts of Artemisia dracunculus, Satureja khuzestanica and Myrtus communis and evaluation of those antimicrobial effects against oral phatogenic microorganisms )Streptococcus sanguinis و Streptococcu mutans and Candida albicans)
Public title
Herbal mouthwash and toothpaste
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion: Normal gums without bleeding or inflammation. Exclusion: Periodontal diseases; usage of antibiotic; Antifungal; Corticosteroid drugs
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
N/A
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
Abadan University of Medical Sciences
Street address
Opposite of Abadan International airpotr,Abadan
City
Abadan
Postal code
6313833177
Approval date
2015-10-26, 1394/08/04
Ethics committee reference number
IRABADANums.REC.1394.34

Health conditions studied

1

Description of health condition studied
The Evaluation of herbal mouthwash and toothpaste on Volunteers
ICD-10 code
B37,B95
ICD-10 code description
B37 Candidial Stomatitis, B95 Bacterial,Viral and other infection agents

Primary outcomes

1

Description
Herbal mouthwash and toothpaste; oral pathogenic Microorganisms
Timepoint
For 6 months
Method of measurement
Evaluation of Herbal mouthwash and toothpaste before and after usage

Secondary outcomes

1

Description
Colony count of oral pathogenic before and after using Herbal mouthwash and toothpaste.
Timepoint
Three months
Method of measurement
The colony count befor and after usage

Intervention groups

1

Description
Intervention : first of all, using herbal toothpaste and then using herbal mouthwash in study period.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Abadan Uinversity of Medical Sciences
Full name of responsible person
Batool Sadeghi-Nejad- Assistant proffesor- Doctoral of Specialist Medical Mycology
Street address
Opposite of Abadan International airport; Abadan
City
Abadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Abadanr University of Medical Sciences
Full name of responsible person
Vice chacellor for research, Dr. Mohammad Mahboby
Street address
Abadan, Opposite International Abadan airport
City
Abadan
Grant name
93u
Grant code / Reference number
020
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Abadanr 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
Abadan Universityl of Medical Sciences
Full name of responsible person
Batool Sadeghi-Nejad
Position
Academic membrane; Assistant professor; Doctoral of Specialist Medical Mycology
Other areas of specialty/work
Street address
Opposite of Abadan International airport, Abadan
City
Abadan
Postal code
6313833177
Phone
+98 615326536162
Fax
+98 61 5326 5363
Email
batsad4@yahoo.com, sadeghi-b@ajums.ac.ir
Web page address
www.abadanums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Batool Sadeghi-Nejad
Position
Academic membrane; Assistant professor; Doctoral of Specialist Medical Mycology
Other areas of specialty/work
Street address
Opposite of Abadan International airport, Abadan
City
Abadan
Postal code
6313833177
Phone
+98 615326536162
Fax
+98 61 5326 5363
Email
batsad4@yahoo.com, sadeghi-b@ajums.ac.ir
Web page address
www.abadanums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Batool Sadeghi Nejad
Position
Academic membrane; Assistant professor; Doctoral of Specialist Medical Mycology
Other areas of specialty/work
Street address
Opposite of International airport, Abadan
City
Abadan
Postal code
6313833177
Phone
+98 615326536162
Fax
+98 61 5326 5363
Email
batsad4@yahoo.comsadeghi-b@ajums.ac.ir
Web page address
www.abadanums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...