Antibacterial Effect of the Infusion of Green Tea Used as a Mouthwash on Saliva and Bacterial Plaque

August 18, 2021 updated by: Julieta María Méndez Romero

Antibacterial Effect of the Infusion of Green Tea (Camellia Sinensis) as a Mouthwash on Saliva and Bacterial Plaque

Given that the participation of oral microorganisms in the development of the most prevalent pathologies of the oral cavity is unquestionable, efforts have been made to create agents that allow controlling these bacteria. The objective of this work was to analyze the antibacterial effect of green tea infusion used as a mouthwash on saliva and bacterial plaque. The green tea infusion was prepared at 13% at approximately 90 ° C, being the same applied to 14 participants from the 1st to the 5th grade (experimental group); and to other 14 participants the placebo was applied (control group). The antibacterial effect was determined by counting the colony forming units (CFU) in the cultures of samples of bacterial plaque and saliva, taken before the application of the infusion and immediately after.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Oral diseases, including dental caries, is one of the most prevalent in the population. It is multifactorial and originates from the formation of the bacterial plaque and its non-elimination by physical and chemical hygiene methods.

The use of chemical agents to aid in the control of Bacterial Plaque has been the subject of study in many investigations. Today there is a variety of elements that can be use to carry out proper oral hygiene, such as toothbrushes, toothpastes, dental floss and mouthwash, all of them in a wide variety.

Often the lack of accessibility to these means problems in the hygiene in the population, either due to the lack of knowledge or the cost of obtaining them.

Therefore, the objective of analyzing the antibacterial effect of the infusion of green tea (camellia sinensis) used as a mouthwash on saliva and bacterial plaque was presented. The proposed research topic is relevant, since if green tea (camellia sinensis) is found to produce positive effects on bacterial plaque, it would serve to prevent its formation, thus helping to improve dental hygiene with an easy acquisition product and lower cost compared to other mouthwashes offered in the market, constituting a natural mouthwash.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Paraguay
    • Caaguazu
      • Coronel Oviedo, Caaguazu, Paraguay, 3300
        • Facultad de Odontología, Universidad nacional de Caaguazu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants that signed the informed consent

Exclusion Criteria:

  • allergic to green tea (Camellia sinensis)
  • ongoing medical or dental treatment that could interfere with the results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GREEN TEA MOUTH WASH
an infusion at 13%, with 13 g of green tea (commercially divided) in 100 ml of saline solution, at a temperature of approximately 90 ° C.
Other: Green Tea mouthwash

an infusion at 13%, with 13 g of green tea (commercially divided) in 100 ml of saline solution, at a temperature of approximately 90 ° C, in sterile glass containers.

Each application was 10 ml. applied for 1 minute.
Placebo Comparator: Placebo
distilled water, in sterile glass containers.
Other: Placebo Mouthwash
distilled water

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bacterial plaque Stage 1 (Before intervention)
Time Frame: thorough study completion, an average of 24 hours
The measure was done with the count of Colony forming units
thorough study completion, an average of 24 hours
Bacterial plaque Stage 2 (After intervention)
Time Frame: 1 minute after mouthwash use
The measure was done with the count of Colony forming units
1 minute after mouthwash use
Antimicrobial effect
Time Frame: up to 24 hours, thorough study completion
The measure was done with the difference in count of Colony forming units before and after intervention
up to 24 hours, thorough study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Julieta María Méndez Romero

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jazmin Servin, Facultad de Odontología, Universidad nacional de Caaguazu
  • Study Director: Nelson Portillo, Facultad de Odontología, Universidad nacional de Caaguazu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 21, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 21, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 21, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 00139

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

By email

IPD Sharing Time Frame

From the time the protocol is available in clinical trials.gov and with no limit of time

IPD Sharing Access Criteria

Researchers that want to know about the study and use the protocol

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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