In this study, after preparing the mouthwash containing the extract of both mentioned substances and ensuring its quality and performing microbial and cell vitality tests in order to determine the anti-caries and anti-biofilm properties, we will investigate the effect of this mouthwash on the that cause tooth decay and compare it with CHX mouthwash on 150 volunteers and the final formulation will be presented as a laboratory mouthwash.
Design
In this study, the blinding process for the participants will be done by similarization
mouthwashes prepared in black containers without labels will be used for the participants so that the participants do not know the type of substance used. The prepared samples will also be sent to the microbiologist in coded form without knowing the intervention group or gold standard.
The method of random allocation of people will be the method of random blocks of 4.
Settings and conduct
Tabriz faculty of dentistry
Participants/Inclusion and exclusion criteria
from healthy people over 18 years of age and without any underlying disease and without any active disease in the oral cavity such as caries and inflammation of the gums and periodontium, who are not taking antibiotics or other drugs during the study process, and who can voluntarily avoid oral hygiene for one day, samples will be taken. Also, people should not have any removable or fixed orthodontic appliance in their mouth and should not use RPDs.
If for any reason the person refuses or is unable to continue the study process, he/she will be excluded from the study.
Intervention groups
Three intervention groups (prescribing propolis mouthwash,Zataria Multiflora and Z.M+P), CHX ( gold standard) and distilled water (control)
Main outcome variables
The number of colonies of Streptococcus mutans and Lactobacillus cultured from the samples
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240429061587N1
Registration date:2024-07-19, 1403/04/29
Registration timing:registered_while_recruiting
Last update:2024-07-19, 1403/04/29
Update count:0
Registration date
2024-07-19, 1403/04/29
Registrant information
Name
Dara Fazlzade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 914 613 1428
Email address
fazlzade@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-09, 1403/02/20
Expected recruitment end date
2024-07-21, 1403/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Zataria multiflora and Propolis mouthwash effect on Streptococcus mutans and Lactobacillus in saliva and dental biofilm
Public title
Evaluation of Zataria multiflora and Propolis mouthwash effect on Streptococcus mutans and Lactobacillus in saliva and dental biofilm
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
18 year old volunteers
without systemic conditions
without active oral cavity disease such as caries or periodontal disease
able to stop oral hygiene maintenance for one day
without using fixed or removable orthodontic appliance or removable partial denture
Exclusion criteria:
Having an underlying disease or an active disease in the oral cavity
Use of fixed or removable orthodontic appliance or removable prosthesis
Unwillingness to participate in the study
Being under 18 years of age
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
The method of random allocation of people will be the method of random blocks of 4.
After collecting the volunteers to participate in the study, by using random allocation online sites and entering the data of the individuals, the allocation of the volunteers to each of the studied groups will be done.
Blinding (investigator's opinion)
Double blinded
Blinding description
The blinding process for the participants will be done by similarization: propolis, Shirazi thyme, propolis + Shirazi thyme and chlorhexidine mouthwashes prepared in black containers without labels will be used for the participants, so that the participants Do not know the type of material used. The prepared samples will also be sent to the microbiologist in coded form without knowing the intervention group or gold standard. Finally, the samples will be sent to the laboratory for microbial culture evaluation and analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The specialized committee of ethics in biomedical research
Street address
South Sheikh Bahai St, Mollasadra St,Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2023-12-29, 1402/10/08
Ethics committee reference number
IR.BMSU.BAQ.REC.1402.090
Health conditions studied
1
Description of health condition studied
Tooth decay-causing microorganisms in saliva and teeth biofilm
ICD-10 code
K02
ICD-10 code description
Dental caries
Primary outcomes
1
Description
The amount of dental caries-causing microorganisms in saliva and dental biofilm
Timepoint
Before and after mouthwash and one week after using mouthwash