Clinical Evaluation of anti plaque and antimicrobial efficacy of bamboo salt toothpaste by culturing of Streptococcus mutans and Lactobacilli and plaque index evaluation
Clinical Evaluation of anti plaque and antimicrobial efficacy of bamboo salt toothpaste by culturing of Streptococcus mutans and Lactobacilli and plaque index evaluation.
Design
In this third-phase RCT, sample size is calculated to be 26 in each group based on previous studies, which will be increased to 30 to improve the validity of study. participants will be assigned to the case (bamboo salt toothpaste) and control (Crest toothpaste) using random number table.
Settings and conduct
After completing the written informed consent by all participants, the baseline plaque index will be determined using the Turesky index and baseline saliva sampling will be performed.
All participants (case group using bamboo salt toothpaste and control group) will be instructed to brush their teeth for two minutes using the Bass technique twice a day for four weeks. Saliva sampling and plaque index determination will be repeated after four weeks of toothpaste use.
For saliva sampling, two milliliters of unstimulated saliva will be transferred into microtubes and immediately transferred to the laboratory of microbiology.
Participants/Inclusion and exclusion criteria
Dental students of Shahid Beheshti dental school aged 18-24 years old
Inclusion Criteria
- Without periodontal pocket depth of more than three millimeters
- Without history of smoking and dry mouth
- Without using of orthodontic appliances
- Without untreated dental caries
- Without history of systemic disease
- History of routine daily toothbrushing with fluoride-containing toothpastes
- Without receiving antibiotic or anti-inflammatory drugs at least one month
- Without allergic reaction to the toothpaste
Intervention groups
case group: consumers of bamboo salt toothpaste
control group: consumers of Crest Complete toothpaste
Main outcome variables
Plaque Index , Streptococcus mutans count , Lactobacillus count
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210414050964N1
Registration date:2021-06-21, 1400/03/31
Registration timing:registered_while_recruiting
Last update:2021-06-21, 1400/03/31
Update count:0
Registration date
2021-06-21, 1400/03/31
Registrant information
Name
Romina Roodgarian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2670 8362
Email address
rominaroodgarian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-21, 1400/03/31
Expected recruitment end date
2021-08-22, 1400/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Evaluation of anti plaque and antimicrobial efficacy of bamboo salt toothpaste by culturing of Streptococcus mutans and Lactobacilli and plaque index evaluation
Public title
Antimicrobial and anti plaque efficacy of herbal toothpaste containing Bamboo salt
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Without periodontal pocket depth of more than three millimeters
Without history of smoking and dry mouth
Without using of orthodontic appliances
Without presence of untreated dental caries
Without history of systemic diseases
routine daily toothbrushing with fluoride-containing toothpastes
Without receiving antibiotic or anti-inflammatory drugs at least one month prior to the study
Without allergic reaction to the toothpaste
Exclusion criteria:
Pregnant
Lactating women
History of using other herbal drugs at least one month prior the study
Age
From 18 years old to 24 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random Assignment
The participants by use of random number table were randomly assigned into the control and case groups
In this method, at first, in order to read the numbers( e.g. up, down, right, and left), the even numbers are considered for the case group, while the odd numbers are consider for the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Considerg the same mint flavour of the two toothpaste, information labels on all toothpaste tubes will be removed and their packages will be all designed similarly, in order to ensure the blinding of participants to the contents of toothpaste tubes. Colony counting will be also performed by a blind microbiologist (by coding the saliva samples, A as control group and B as case group)
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
institutional ethics committee of biomedical research of dental science's institue
Street address
Velenjak St.,Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2020-08-24, 1399/06/03
Ethics committee reference number
IR.SBMU.DRC.REC.1399.033
Health conditions studied
1
Description of health condition studied
anti plaque and antimicrobial efficacy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
plaque index
Timepoint
At baseline and after four weeks of toothpaste use
Method of measurement
plaque indicator
2
Description
Lactobacillus
Timepoint
At baseline and after four weeks of toothpaste use
Method of measurement
cultivating and count bacteria
3
Description
Streptococcus mutans
Timepoint
At baseline and after four weeks of toothpaste use
Method of measurement
cultivating and count bacteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The bamboo salt toothpaste (Tiger Herb®, LG, Korea), The Tiger Herb contains Hydrated Silica, Sodium Chloride (Bamboo Salt), Dipotassium Glycyrrhizinate, Sodium Fluoride, Sorbitol Solution (70%), Cellulose Gum, Sodium Saccharin, Sodium Lauryl Sulfate, Sodium Bisulfate, Blue 1 (E142090), Yellow 10 (47005) Flavor, mint extract and Water. All participants will be instructed to brush their teeth with a medium bristled brush (Oral-B, Ireland) by using 1 centimeter toothpaste for two minutes using the Bass technique twice a day (after breakfast and before bedtime) for four weeks. They will be also instructed to use non-fluoridated dental floss (Oral B, Ireland) every night before going to bed, and refrain from using other fluoride-containing products. Saliva sampling pluque index will be performed at baseline and after four weeks of toothpaste use
Category
Prevention
2
Description
Control group: Crest® Complete toothpaste (Procter & Gamble Plaza, Cincinnati, OH 45202, United States) The Crest Complete toothpaste contains Aqua, Sorbitol, Hydrated Silica, Sodium Lauryl Sulfate, Cellulose Gum, mint extract, Aroma, Zinc Citrate, Chondrus Crispus Powder, Sodium Fluoride (1450 ppm), Sodium Saccharin, Hydroxyl Ethylcellulose, Cl 77891, Sodium Citrate, Stannous Chloride, Silica, Glycerin and Cl 74160. All participants will be instructed to brush their teeth with a medium bristled brush (Oral-B, Ireland) by using 1 centimeter toothpaste for two minutes using the Bass technique twice a day (after breakfast and before bedtime) for four weeks. They will be also instructed to use non-fluoridated dental floss (Oral B, Ireland) every night before going to bed, and refrain from using other fluoride-containing products. Saliva sampling pluque index will be performed at baseline and after four weeks of toothpaste use
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti dental school
Full name of responsible person
Mina Biria
Street address
Velenjak St., Shahid Chamran Highway
City
تهران
Province
Tehran
Postal code
1983963113
Phone
+98 21 2670 8362
Email
dr.biriam@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Romina Roodgarian
Street address
Velenjak St., Shahid Chamran Highway
City
تهران
Province
Tehran
Postal code
1983963113
Phone
+98 21 2670 8362
Email
rominaroodgarian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mina Bira
Position
Assistant Prof., Department of Pediatric Dentistry, School of Dentistry, Shahid Beheshti University
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Velenjak St., Shahid Chamran Highway
City
تهران
Province
Tehran
Postal code
1983963113
Phone
+98 21 2670 8362
Email
drbiriam@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mina Biria
Position
Assistant Prof., Department of Pediatric Dentistry, School of Dentistry, Shahid Beheshti University
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Velenjak St., Shahid Chamran Highway
City
تهران
Province
Tehran
Postal code
1983963113
Phone
+98 21 2670 8362
Email
drbiriam@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Romina Roodgarian
Position
Resident of pediatric dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Velenjak St., Shahid Chamran Highway
City
تهران
Province
Tehran
Postal code
1983963113
Phone
+98 21 2670 8362
Email
rominaroodgarian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD