This study is a Double-Blind Randomized Crossover Clinical Trial that will be done on 22 students of Rafsanjan Dental School, who meet the inclusion criteria. First, mouthwash with 25% concentration of Teucrium polium (TP) is provided. The volunteers will randomly be divided into two groups, the first group will take TP mouthwash and the second group will take placebo. Volunteers will use 15cc of mouthwash for two weeks, and twice a day, and each time for 30 seconds in the oral cavity and will not drink and not rinse mouth until 30min. At 10 am, two cc of saliva without any provocation by spitting will be collected in a sterile tube. Patients then entered a period of three weeks Washout (no mouthwash or placebo). Again, saliva will be collected. In the second stage, the first group will receive placebo and the second group will take TP mouthwash for two weeks. After this point saliva samples will be collected. Streptococcus mutans counts in saliva samples will be done in the microbiology laboratory.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013121815842N1
Registration date:2014-06-16, 1393/03/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-16, 1393/03/26
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
Rafsanjan University of Medical Sciences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Teucrium polium mouth-wash effect on salivary Mutans streptococci
Public title
Teucrium polium mouth-wash 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 18 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rafsanjan University of Medical Sciences
Street address
Rafsanjan University of Medical Sciences, Imam Ali street, Rafsanjan, kerman
City
Rafsanjan
Postal code
7717933777
Approval date
2014-05-22, 1393/03/01
Ethics committee reference number
315/9/31پ د
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
before intervention /2weeks after intervention/ before the secind intervention/2weeks after the second intervention
Method of measurement
count of colonies in culture
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: 15 cc Teucrium polium mouth-wash 2weeks/ twice a day, and each time for 30 seconds swish in oral cavity
Category
Treatment - Drugs
2
Description
control group: mouth-wash contains distilled water instead of TP 15 cc placebo 2weeks/ twice a day, and each time for 30 seconds swish in oral cavity15 cc mouth-wash 2weeks/ twice a day, and each time for 30 seconds swish in oral cavity