Introduction: Several studies have reported the antibacterial effect of Teucrium polium extract. The purpose of this study is to determine the effect of chewing gum containing Teucrium polium extract on the number of salivary Streptococcus mutans.
Materials and Methods: In this clinical trial, 30 dental students are randomly divided into two groups. The first group is intervention and will receive chewing gum containing Teucrium polium extract. The second group is control and will receive chewing gum with any plant extract. For elimination of the possibility of any probable bias due to the knowledge of participant and researcher, we will perform a double blind study.Each person should chew the chewing gum for 20 minutes for three weeks and three times a day after each meal. Unstimulated saliva samples will collect at the beginning of the experiment and before the use of gum, and one day after the final gum consumption. The Quantitative Polymerase Chane Reaction (qPCR) method will use to determine the bacterial colonization. The comparison of the colonization rate of Streptococcus mutans between groups is done by T-test. Statistical calculations will performe using SPSS ver.21 software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082615842N3
Registration date:2017-09-02, 1396/06/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-02, 1396/06/11
Registrant information
Name
Somayeh Khoramian Tusi
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3353 1614
Email address
dr.khoramian@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Alborz University of Medical Sciences
Expected recruitment start date
2017-04-06, 1396/01/17
Expected recruitment end date
2017-05-07, 1396/02/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of chewing gum with Teucrium polium on salivary Streptococcus mutans counts
Public title
Teucrium polium chewing gum effect on dental caries prevention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: not using antibiotics in the past month; optimal oral health (dental plaque index smaller or equal to 20%); lack of Orthodontic Appliances Exclusion criteria: using antibiotics in the past month; poor oral health (dental plaque index larger than20%); having Orthodontic Appliances
Age
From 20 years old to 30 years old
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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization will be performed by the Randlist software
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Alborz University of Medical Sciences
Street address
Karaj, Taleghani st.
City
Karaj
Postal code
Approval date
2017-02-25, 1395/12/07
Ethics committee reference number
Abzums.rec.1396,24
Health conditions studied
1
Description of health condition studied
Dental Caries
ICD-10 code
K02
ICD-10 code description
Dental Caries
Primary outcomes
1
Description
salivary Mutans streptococci count
Timepoint
at the beginning of the experiment and before the use of gum, and one day after the final gum consumption
Method of measurement
qPCR
Secondary outcomes
empty
Intervention groups
1
Description
intervention group:Each person chewed the Teucrium polium gum for 20 minutes for three weeks and three times a day after each meal.
control group:Each person chewed the placebo gum for 20 minutes for three weeks and three times a day after each meal.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alborz Dental School
Full name of responsible person
Somayeh Khoramian Tusi
Street address
Katuyeezadeh Sq., 45 Metri Golshahr
City
Karaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Mohammad Noorisepehr
Street address
Alborz University of Medical Sciences
City
Karaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz 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
Alborz University of Medical Sciences
Full name of responsible person
Somayeh Khoramian Tusi
Position
Assistant professor of Alborz Dental School
Other areas of specialty/work
Street address
Alborz Dental School
City
Karaj
Postal code
Phone
+98 26 3353 1614
Fax
Email
so_khoramian@yahoo.comdrkhoramian@abzums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Somayeh Khoramian Tusi
Position
Pediatric dentist
Other areas of specialty/work
Street address
Alborz Dental School
City
Karaj
Postal code
Phone
+98 26 3353 1614
Fax
Email
drkhoramian@abzums.ac.irso_khoramian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Somayeh Khoramian Tusi
Position
pediatric dentist
Other areas of specialty/work
Street address
Karaj, Taleghani st.
City
Karaj
Postal code
Phone
+98 26 3353 1614
Fax
Email
drkhoramian@abzums.ac.irso_khoramian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)