Objective: effect of sage plant extract (salvia officinalis) gel on dental plaque
streptococus mutans microorganism and periodontal indexs.
A double blind clinical trial study was conducted on
70 students(35 girl/35 boy) (aged 11-12 years) with same systemic, socioeconomic condition, oral hygiene, periodontal condition(BOP-/pocket probing mm3≥/without attachment loss) and plaque index.
Individuals that used any antibiotics or mouthwash and toothpaste containing antibacterial components were excluded from this study.
These students were randomly divided into two groups. The first group (35 students) was given the dental gel with sage extracts and the second group (35 students)was given the the placebo gel (without sage extract and any antibacterial or anti inflammatory components with same color and odor). Dental plaque microorganisms that obtained from buccal surfaces were entered in BHI 1cc medium and then cultured in MSB medium immediately. PI, GBI and the number of streptococus mutans colonies was measured in the first and 30 days later.
Before starting therapy all subjects are given a same hygienic kit includes toothbrush, toothpaste, floss and test or control gel and correct manner of brushing instructed them.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012070710204N1
Registration date:2012-08-31, 1391/06/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-31, 1391/06/10
Registrant information
Name
Maryam Beheshti Rouy
Name of organization / entity
Hamadan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 1984
Email address
m.beheshti@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan Universiy of Medical Sciences
Expected recruitment start date
2012-06-16, 1391/03/27
Expected recruitment end date
2012-08-17, 1391/05/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of sage plant extract (salvia officinalis) gel on dental plaque
streptococus mutans microorganism and periodontal indexs.
Public title
Effect of sage extract on caries and periodontal problems control.
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria:
subjects with same systemic, socioeconomic condition,oral hygiene,periodontal condition(BOP-/pocket probing mm3≥/without attachment loss)and plaque index were included in this study.
exclusion criteria:
individuals that used any antibiotics or mouthwash and toothpaste containing antibacterial components were excluded from this study.
Age
From 12 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamadan University of Medical Sciences Ethics Committee
Street address
Hamadan. Shahid Fahmideh ave. Opposite of Mardom park
City
Hamadan
Postal code
65178-38677
Approval date
2012-06-16, 1391/03/27
Ethics committee reference number
16/35/9/1010/پ/د
Health conditions studied
1
Description of health condition studied
dental caries and periodontal diseases
ICD-10 code
Y56.7
ICD-10 code description
Dental drugs, topically applied
Primary outcomes
1
Description
microorganism count in medium
Timepoint
at beginning of study and 30 days later
Method of measurement
visual counting of microorganism in medium
2
Description
PI
Timepoint
at beginning of study and 30 days later
Method of measurement
visual estimating of PI
3
Description
GBI
Timepoint
at beginning of study and 30 days later
Method of measurement
visual estimating GBI
Secondary outcomes
1
Description
caries
Timepoint
at the first and 6 mount later
Method of measurement
visual and radiographical assessment of caries
2
Description
gingivitis
Timepoint
at the first and 6 mount later
Method of measurement
checking of gingivitis signs with BOP,PI,GBI ind
Intervention groups
1
Description
In the intervention group, subjects rub the sage gel with finger fine as the half size of toothbrush head on teeth and adjucent gingiva after complete brushing every night for 30 nights.
Category
Treatment - Drugs
2
Description
In the control group, subjects rub the placebo gel with finger fine as the half size of toothbrush head on teeth and adjucent gingiva after complete brushing every night for 30 nights.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Welfare organization
Full name of responsible person
Street address
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan University of Medical Sciences.Vice Chancellor for Research and Technology
Full name of responsible person
Dr Heydar Tavilani
Street address
Hamadan, Shariati ave, Shahid Fahmideh blv, Hamadan Dental Faculty.Vice Chancellor for Research and Technology
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan University of Medical Sciences.Vice Chancellor for Research and Technology
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
Hamadan University of Medical Sciences
Full name of responsible person
Dr Maryam Beheshti Rouy
Position
Assistant professor
Other areas of specialty/work
Street address
Hamadan Dental Faculty
City
Hamadan
Postal code
Phone
+98 81 1835 4017
Fax
Email
m.beheshti@umsha.ac.ir; beheshtirouym@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr Maryam Beheshti Rouy
Position
Assistant professor
Other areas of specialty/work
Street address
Hamadan Dental Faculty
City
Hamadan
Postal code
Phone
+98 81 1835 4017
Fax
Email
m.beheshti@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr Amin Khodadoustan
Position
Assistant professor
Other areas of specialty/work
Street address
Hamadan Dental Faculty
City
Hamadan
Postal code
Phone
+98 81 1835 4017
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)