Antibacterial efficacy of non-thermal atmospheric pressure plasma against Streptococcus mutans and lactobacillus acidophilus of carious dentin: a clinical study
evaluating of Antibacterial efficacy of non-thermal atmospheric pressure plasma against Streptococcus mutans and lactobacillus acidophilus of carious dentin
Design
before and after the intervention dental cavity samples are entered into the transfer container of the culture medium with the help of a dental excavator. Then it is transferred to the laboratory.
Settings and conduct
The patient's sample is collected in equal amounts before and after the treatment as much as possible in Eppendorf tubes containing a reduced thioglycollate-based transfer medium without glucose. The samples are transferred to the microbiology research laboratory of Tehran University of Medical Sciences at ambient temperature within 24 hours. In the laboratory, the received samples are normalized in terms of the amount of clinical samples in them to the lowest amount of samples taken from patients. After receiving the samples, the samples will be homogenized using an ultrasonic device.
Then the samples are doubled in 96-well microplates for serial dilution. Mitis Salivarius agar containing valinomycin (MS-MUTV) and De Man Rogosa Sharpe agar containing maltose (MRSM) are used as selective and differential media for the detection and counting (determination of CFU/mL) of S. mutans and L. acidophilus, respectively. After inoculation, the media are incubated for 48 hours in capnophilic conditions created by Gazpak in jars at 37°C. Then the CFU/mL of the studied bacteria will be calculated.
Participants/Inclusion and exclusion criteria
patients with cavitated dental caries, without systemic disorders and endodontic dental pain
Intervention groups
Bacteria samples will be take in patients with cavitated dental caries before and after non thermal atmospheric pressure plasma and compared.
Main outcome variables
The amount of CFU bacteria Streptococcus mutans and Lactobacillus acidophilus before and after the intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221101056372N1
Registration date:2022-12-24, 1401/10/03
Registration timing:registered_while_recruiting
Last update:2022-12-24, 1401/10/03
Update count:0
Registration date
2022-12-24, 1401/10/03
Registrant information
Name
mandana karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8611 2910
Email address
mandanakarimi1374@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-10, 1401/09/19
Expected recruitment end date
2023-03-10, 1401/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Antibacterial efficacy of non-thermal atmospheric pressure plasma against Streptococcus mutans and lactobacillus acidophilus of carious dentin: a clinical study
Public title
Antibacterial efficacy of non-thermal atmospheric pressure plasma on dental caries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
dental cavitaed caries
Exclusion criteria:
systemic diseases
endodontic dental pain
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
More than 1 sample in each individual
Number of samples in each individual:
3
number of dental caries with cavity and good access
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
dentistry school, Tehran university of medical science
Street address
no 10, 34th street, Gisha
City
Tehran
Province
Tehran
Postal code
1448985464
Approval date
2022-10-30, 1401/08/08
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1401.101
Health conditions studied
1
Description of health condition studied
dental caries
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The CFU of dental caries bacteria
Timepoint
before and after
Method of measurement
Mitis Salivarius agar containing valinomycin and De Man Rogosa Sharpe agar containing maltose are used as selective and differential media for the detection and counting (determination of CFU/mL) of S. mutans and L. acidophilus, respectively.
Secondary outcomes
empty
Intervention groups
1
Description
The studied population is people who have referred to the restorative department of Tehran Dental School for teeth restoration. After explaining the procedure to the patient and obtaining written consent from them, the patients are tested. The teeth that have cavities and clinical symptoms of spontaneous pain, irreversible pulpitis and deep decay are selected for study. The caries of the surface area (baseline samples) is removed with the help of a small size excavator, 2 mm long, 1 mm wide and 0.5 mm deep, equal to the volume of the excavator, and placed in an Ependorf tube containing a reduced transition medium based on thioglycollate without glucose. Then cold helium plasma is applied to the decay cavity by a plasma device containing helium gas (purity 99.999%) with a nozzle diameter of 3 mm, voltage of 10 kV, frequency of 6 kHz at a distance of 1 cm from the decay cavity for one minute and another sterile excavator of another sample is prepared in the vicinity and at the same level as the baseline sample, equal to the volume of the small size exciter, and is placed in an Ependorf tube containing a reduced transfer medium based on thioglycolate without glucose.Before treatment and after treatment, as much as possible, the patient's samples are collected in equal amounts in Ependorf tubes containing a reduced thioglycollate-based transfer medium without glucose. The samples are transferred to the microbiology research laboratory of Tehran University of Medical Sciences at ambient temperature within 24 hours. Mitis Salivarius agar containing valinomycin (MS-MUTV) and De Man Rogosa Sharpe agar containing maltose (MRSM) are used as selective and differential media for tracking and counting (determination of CFU/mL) S. mutans and L. acidophilus, respectively. to be After inoculation, the media are incubated for 48 hours in capnophilic conditions created by Gazpak in jars at 37°C. Then the CFU/mL of the studied bacteria will be calculated. Finally, the obtained numbers will be subjected to statistical analysis. The relationship between plasma and its effect on the number of bacteria on the tested samples is investigated. The significance level in this study is considered 0.05 (P value = 0.05).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
dentistry school of Tehran university of medical science
Full name of responsible person
Mandana Karimi
Street address
North Kargar
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8835 1258
Email
mandanakarimi1374@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
اکبر فتوحی
Street address
no 10, 34th or Ghaziasadollahi street, Gisha
City
tehran
Province
Tehran
Postal code
1448985464
Phone
+98 21 8611 2910
Email
mandanakarimi1374@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
mandana karimi
Position
post graduate student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
no 10, 34th street, Gisha
City
tehran
Province
Tehran
Postal code
1448985464
Phone
+98 21 8611 2910
Email
Mandanakarimi1374@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
mandana karimi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
no 10, 34th street, Gisha
City
tehran
Province
Tehran
Postal code
1448985464
Phone
+98 21 8611 2910
Email
mandanakarimi1374@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mandana Karimi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
no 10, 34th Ave, Gisha
City
Tehran
Province
Tehran
Postal code
1448985464
Phone
+98 21 8611 2910
Email
mandanakarimi1374@yahoo.com
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Raw data and analysis of bacterial counts are available for publication. Other data cannot be published.e
When the data will become available and for how long
access to data from 2024
To whom data/document is available
for researchers working in academic institutions
Under which criteria data/document could be used
For researchers, the CFU data of bacteria samples and analysis will be available.
From where data/document is obtainable
mandana karimi
Mandanakarimi1374@yahoo.com
What processes are involved for a request to access data/document
request to the researcher of thesis and determine clearly the purpose