Antibacterial Effect of the Infusion of Green Tea Used as a Mouthwash on Saliva and Bacterial Plaque
Primary Purpose
Dental Plaque
Status
Completed
Phase
Not Applicable
Locations
Paraguay
Study Type
Interventional
Intervention
Green Tea mouthwash
Placebo Mouthwash
Sponsored by
About this trial
This is an interventional prevention trial for Dental Plaque focused on measuring Saliva, Mouthwash, Green Tea, Oral bacteria
Eligibility Criteria
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.
Sites / Locations
- Facultad de Odontología, Universidad nacional de Caaguazu
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
GREEN TEA MOUTH WASH
Placebo
Arm Description
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.
distilled water, in sterile glass containers.
Outcomes
Primary Outcome Measures
Bacterial plaque Stage 1 (Before intervention)
The measure was done with the count of Colony forming units
Bacterial plaque Stage 2 (After intervention)
The measure was done with the count of Colony forming units
Antimicrobial effect
The measure was done with the difference in count of Colony forming units before and after intervention
Secondary Outcome Measures
Full Information
NCT ID
NCT04410666
First Posted
May 24, 2020
Last Updated
August 18, 2021
Sponsor
Julieta María Méndez Romero
1. Study Identification
Unique Protocol Identification Number
NCT04410666
Brief Title
Antibacterial Effect of the Infusion of Green Tea Used as a Mouthwash on Saliva and Bacterial Plaque
Official Title
Antibacterial Effect of the Infusion of Green Tea (Camellia Sinensis) as a Mouthwash on Saliva and Bacterial Plaque
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 21, 2016 (Actual)
Primary Completion Date
September 21, 2016 (Actual)
Study Completion Date
September 21, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Julieta María Méndez Romero
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque
Keywords
Saliva, Mouthwash, Green Tea, Oral bacteria
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental group: 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.
Control group: distilled water, in sterile glass containers. Each application was 10 ml. applied for 1 minute.
Masking
Participant
Masking Description
It was single blind, since the patient did not wat treatment was receiving. It was used a placebo.
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GREEN TEA MOUTH WASH
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
distilled water, in sterile glass containers.
Intervention Type
Other
Intervention Name(s)
Green Tea mouthwash
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo Mouthwash
Intervention Description
distilled water
Primary Outcome Measure Information:
Title
Bacterial plaque Stage 1 (Before intervention)
Description
The measure was done with the count of Colony forming units
Time Frame
thorough study completion, an average of 24 hours
Title
Bacterial plaque Stage 2 (After intervention)
Description
The measure was done with the count of Colony forming units
Time Frame
1 minute after mouthwash use
Title
Antimicrobial effect
Description
The measure was done with the difference in count of Colony forming units before and after intervention
Time Frame
up to 24 hours, thorough study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jazmin Servin
Organizational Affiliation
Facultad de Odontologia, Universidad Nacional de Caaguazu
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nelson Portillo
Organizational Affiliation
Facultad de Odontologia, Universidad Nacional de Caaguazu
Official's Role
Study Director
Facility Information:
Facility Name
Facultad de Odontología, Universidad nacional de Caaguazu
City
Coronel Oviedo
State/Province
Caaguazu
ZIP/Postal Code
3300
Country
Paraguay
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
24624389
Citation
Ardakani MR, Golmohammadi S, Ayremlou S, Taheri S, Daneshvar S, Meimandi M. Antibacterial effect of Iranian green-tea-containing mouthrinse vs chlorhexidine 0.2%: an in vitro study. Oral Health Prev Dent. 2014;12(2):157-62. doi: 10.3290/j.ohpd.a31663.
Results Reference
background
PubMed Identifier
30589005
Citation
Megalaa N, Thirumurugan K, Kayalvizhi G, Sajeev R, Kayalvizhi EB, Ramesh V, Vargeese A. A comparative evaluation of the anticaries efficacy of herbal extracts (Tulsi and Black myrobalans) and sodium fluoride as mouthrinses in children: A randomized controlled trial. Indian J Dent Res. 2018 Nov-Dec;29(6):760-767. doi: 10.4103/ijdr.IJDR_790_16.
Results Reference
background
PubMed Identifier
27054861
Citation
Ronanki S, Kulkarni S, Hemalatha R, Kumar M, Reddy P. Efficacy of commercially available chlorhexidine mouthrinses against specific oral microflora. Indian J Dent Res. 2016 Jan-Feb;27(1):48-53. doi: 10.4103/0970-9290.179816.
Results Reference
background
PubMed Identifier
31883255
Citation
Hajiahmadi M, Yegdaneh A, Homayoni A, Parishani H, Moshkelgosha H, Salari-Moghaddam R. Comparative Evaluation of Efficacy of "Green Tea" and "Green Tea with Xylitol" Mouthwashes on the Salivary Streptococcus mutans and Lactobacillus Colony Count in Children: A Randomized Clinical Trial. J Contemp Dent Pract. 2019 Oct 1;20(10):1190-1194.
Results Reference
background
PubMed Identifier
34424217
Citation
Servin J, Mendez J, Portillo N, Villasanti U. Antibacterial effect of green tea infusion used as a mouthwash on saliva and bacterial plaque: a randomized controlled trial. Gen Dent. 2021 Sep-Oct;69(5):72-74.
Results Reference
derived
Learn more about this trial
Antibacterial Effect of the Infusion of Green Tea Used as a Mouthwash on Saliva and Bacterial Plaque
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