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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04410666
Other study ID # 00139
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 21, 2016
Est. completion date September 21, 2016

Study information

Verified date August 2021
Source Universidad Nacional de Caaguazu
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date September 21, 2016
Est. primary completion date September 21, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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 Mouthwash
distilled water

Locations

Country Name City State
Paraguay Facultad de Odontología, Universidad nacional de Caaguazu Coronel Oviedo Caaguazu

Sponsors (1)

Lead Sponsor Collaborator
Julieta María Méndez Romero

Country where clinical trial is conducted

Paraguay, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Bacterial plaque Stage 1 (Before intervention) The measure was done with the count of Colony forming units thorough study completion, an average of 24 hours
Primary Bacterial plaque Stage 2 (After intervention) The measure was done with the count of Colony forming units 1 minute after mouthwash use
Primary Antimicrobial effect The measure was done with the difference in count of Colony forming units before and after intervention up to 24 hours, thorough study completion
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