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

NCT04410666 | Completed

• 1 other identifier: 00139
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Plaque

Keywords

Saliva; Mouthwash; Green Tea; Oral bacteria

Outcome Measures

Primary Outcomes (3)

• 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

• Bacterial plaque Stage 2 (After intervention)

  The measure was done with the count of Colony forming units

  1 minute after mouthwash use

• 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

Study Arms (2)

GREEN TEA MOUTH WASH

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

distilled water, in sterile glass containers.

Other: Placebo Mouthwash

Interventions

Green Tea mouthwash OTHER

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.

GREEN TEA MOUTH WASH

Placebo Mouthwash OTHER

distilled water

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants that signed the informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Julieta María Méndez Romero: lead

Study Sites (1)

Facultad de Odontología, Universidad nacional de Caaguazu

Coronel Oviedo, Caaguazú Department, 3300, Paraguay

Location

Related Publications (5)

• 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.

  PMID: 24624389 BACKGROUND

• 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.

  PMID: 30589005 BACKGROUND

• 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.

  PMID: 27054861 BACKGROUND

• 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.

  PMID: 31883255 BACKGROUND

• 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.

  PMID: 34424217 DERIVED

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Jazmin Servin

  Facultad de Odontologia, Universidad Nacional de Caaguazu

  PRINCIPAL INVESTIGATOR

• Nelson Portillo

  Facultad de Odontologia, Universidad Nacional de Caaguazu

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: It was single blind, since the patient did not wat treatment was receiving. It was used a placebo.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Writting and Publication Department, Regional Health Research Institute

Model Details: 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.

Study Record Dates

• First Submitted: May 24, 2020
• First Posted: June 1, 2020
• Study Start: August 21, 2016
• Primary Completion: September 21, 2016
• Study Completion: September 21, 2016
• Last Updated: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From the time the protocol is available in clinical trials.gov and with no limit of time
• Access Criteria: Researchers that want to know about the study and use the protocol

Locations

PA (1)