Objective: This study aims to evaluate the effect of Magnolia Grandiflora bark mouth-wash on prevalence of Streptococcus mutans in dental plaque.
Materials and Methods: In this crossover study, initially an aqua-ethanol extract of Magnolia Grandiflora bark will be obtained. Using a standard strain of S. mutans (ATCC 35668), the MIC of the Magnolia extract will be determined. In concordance with the MIC concentration, a mouthwash will be provided from the extract. Twenty volunteers will be entered the study to use this mouthwash and a placebo in crossover arrangements in case and control groups respectively. The prevalence of S. mutans will be measured in certain volume of volunteer’s dental plaque at the beginning of the project (phase 1), after the first prescription (phase 2), following the wash out period (phase 3) and finally after the second prescription (phase 4) by culture on bacteriology media including blood agar and Mitis Bacitracin Salivarius Agar. Also the Plaque Percent Index will be calculated at each phase.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014071518487N1
Registration date:2015-01-22, 1393/11/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-22, 1393/11/02
Registrant information
Name
Fateme Ghorbani
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 9210
Email address
m.zare@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Shahed University
Expected recruitment start date
2014-02-09, 1392/11/20
Expected recruitment end date
2014-04-09, 1393/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Magnolia mouthwash on the levels of S. mutans in dental plaque and on the Plaque Percent Index
Public title
The Effect of Magnolia mouthwash on dental caries and periodontal diseases
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Ages 18 to 35; Absence of systemic disease
Exclusion criteria: Consumption of antibiotics from one month prior to the study; Active dental caries
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
All participants will be asked not to change their usual methods for their oral and dental health. With regards to their oral health status, all participants will be classified into two groups of moderate health (A) and poor health (B) based on the standard table for initial assessment of caries risk and the Plaque Percent Index.
K02:Caries limited to enamel,dentin,cementume, K05:Gingivitis and periodontal diseases
Primary outcomes
1
Description
The quantity of Streptococcus mutans in dental plaque
Timepoint
Before the study, a week after the first intervention, a week after the rest period, a week after the second intervention
Method of measurement
Bacterial counts
2
Description
Plaque Index Percentage
Timepoint
Before the study, a week after the first intervention, a week after the rest period, a week after the second intervention
Method of measurement
Plaque staining on dental surfaces and using standard formula for measuring Plaque Index Percentage
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Using Magnolia mouthwash, Volume: 15 cubic centimeters for each use, duration: One week after the last meal before bed every night, Method: 30 seconds of turning the mouthwash in the mouth
Category
Treatment - Drugs
2
Description
Control group: Using Placebo, Volume: 15 cubic centimeters for each use, duration: One week after the last meal before bed every night, Method: 30 seconds of turning the Placebo in the mouth
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
DR Saied Amel Jamehdar
Street address
Microbiology Department, Centeral Laboratory, Imam Reza Hospital, Taghi Abad Square
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Dr Roza Haghgoo
Street address
NO 39, Italia Street, Keshavarz Bulvard, Shahed Dentistry School
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Roza Haghgoo
Position
Associate professor in Pediatric Dentistry
Other areas of specialty/work
Street address
NO39, Shahed Dentistry school, Italia Street, Keshavarz Bulvard
City
Tehran
Postal code
Phone
+98 912 359 8450
Fax
Email
haghgoodent@yahoo.com; fatemeqorbani66@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Fateme Ghorbani
Position
Student of dentistry
Other areas of specialty/work
Street address
NO39, Shahed Dentistry School, Italia Street, Keshavarz Boulevard
City
Tehran
Postal code
Phone
+98 915 762 4338
Fax
Email
fatemeqorbani66@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Fateme ghorbani
Position
Student of Dentistry
Other areas of specialty/work
Street address
NO39, Shahed Dentistry school, Italia Street, Keshavarz Bulevard
City
Tehran
Postal code
Phone
+98 915 762 4338
Fax
Email
fatemeqorbani66@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)