Clinical trial comparing the effect of standard toothpaste and herbal toothpaste containing berberine and saponin on dental plaque, gingival inflammation, and salivary bacterial count
To compare the effect of standard toothpaste and herbal toothpaste containing berberine and saponin on dental plaque, gingival inflammation, and salivary bacterial count
Design
Two-arm parallel-group, randomized, non-blinded trial in phase 2 incorporating 60 participants. A table of random numbers will be used for randomization.
Settings and conduct
The study is conducted in the School of Dentistry of Birjand University of Medical Sciences. After the correct manner of brushing is taught to them, one group uses standard toothpaste and the other group uses herbal toothpaste for 7 months.
Participants/Inclusion and exclusion criteria
Major inclusion criteria: Having a minimum of 24 teeth and non-consumption of antibiotics from 2 weeks before saliva sampling. Exclusion criteria: The presence of systemic problems such as diabetes and the presence of cavities
Intervention groups
Intervention group 1 (standard toothpaste): After the correct manner of brushing is trained to them, participants will brush their teeth twice daily for 3-5 minutes for a period of seven months using the classic Crest toothpaste. Intervention group 2 (Herbal toothpaste): After the correct manner of brushing is trained to them, participants will brush their teeth twice daily for 3-5 minutes for a period of seven months using the herbal toothpaste containing berberine and saponin.
Main outcome variables
dental plaque, gingival inflammation, and salivary bacterial count
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170316033099N13
Registration date:2021-05-02, 1400/02/12
Registration timing:prospective
Last update:2021-05-02, 1400/02/12
Update count:0
Registration date
2021-05-02, 1400/02/12
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
roozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparing the effect of standard toothpaste and herbal toothpaste containing berberine and saponin on dental plaque, gingival inflammation, and salivary bacterial count
Public title
The effect of herbal toothpaste containing berberine and saponin on oral and dental health
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having a minimum of 24 teeth
Signing informed consent form for participation in the study
Non-consumption of antibiotics from 2 weeks before saliva sampling
Exclusion criteria:
Presence of systemic problems such as diabetes
Presence of cavities
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Each participant will be assigned a code between 1 and 60. They will be allocated to intervention group 1 or intervention group 2 using the table of random numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2021-02-13, 1399/11/25
Ethics committee reference number
IR.Bums.Rec.1399.543
Health conditions studied
1
Description of health condition studied
Oral and dental health
ICD-10 code
K05
ICD-10 code description
Gingivitis and periodontal diseases
Primary outcomes
1
Description
dental plaque
Timepoint
baseline, months 3, 5, and 7 after baseline
Method of measurement
Plaque Index
2
Description
gingival inflammation
Timepoint
baseline, months 3, 5, and 7 after baseline
Method of measurement
Gingival Index
3
Description
Lactobacillus and Streptococcus mutans bacteria
Timepoint
baseline, months 3, 5, and 7 after baseline
Method of measurement
saliva swab
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 (standard toothpaste): After the correct manner of brushing is trained to them, participants will brush their teeth twice daily for 3-5 minutes for a period of seven months using the classic Crest toothpaste.
Category
Prevention
2
Description
Intervention group 2 (Herbal toothpaste): After the correct manner of brushing is trained to them, participants will brush their teeth twice daily for 3-5 minutes for a period of seven months using the herbal toothpaste containing berberine and saponin.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Mohammadreza Mofateh
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3242 5402
Email
drmofatteh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
100
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
Birjand University of Medical Sciences
Full name of responsible person
Dr. Hamid Ahmadi
Position
Dentist
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Ghaffari St.,
City
Birjand,
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1708
Fax
Email
hamid.ahmd.97@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Zoya Tahergorabi
Position
Assoicate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Ghaffari St.,
City
Birjand,
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5680
Fax
Email
z.tahergorabi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
Translator
Latest degree
Master
Other areas of specialty/work
Others
Street address
Ghaffari St.,
City
Birjand,
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5680
Fax
+98 56 3242 0447
Email
roozgar@bums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Deidentified Individual Participant Data Set
When the data will become available and for how long
After the paper extracted from the project is published and for 6 months
To whom data/document is available
Researchers
Under which criteria data/document could be used
Research purposes
From where data/document is obtainable
Personal correspondence with the corresponding author
What processes are involved for a request to access data/document