Evaluation of Antimicrobial Efficacy of Green Tea, Garlic With Lime, Pomegranate Extract and Chlorhexidine Mouth Rinses in a Group of Egyptian Children (In-Vivo Study)

the aim of the clinical trial is to evaluate the antimicrobial efficacy of the herbal mouth rinses against chlorhexidine mouth rinse.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Procedure: Green tea extract mouth rinse; Procedure: Garlic with lime extract mouth rinse; Procedure: Pomegranate extract mouth rinse; Procedure: Chlorhexidine mouth rinse

Detailed Description

The present study was carried out on 84 children. Children were recruited based on certain inclusion criteria after signing a written informed consent by their parents. They were divided into 4 groups. Group (I) the children rinsed with Chlorhexidine mouth rinse, the child rinsed for 1 minute and plaque samples were collected from the child before and after rinsing. Group (II) children rinsed with green tea extract, while group (III) children rinsed with garlic with lime extract and group (IV) the children rinsed with pomegranate extract mouth rinse with the same procedures. .child satisfaction was measured using 5-point pictorial likert scale which is graded from 1 to 5 (1.Excellent.2.Good.3 Average 4.Poor. 5. Very poor).

All the plaque samples were collected and put in sterile test tubes containing thioglycolate as a transport media. They transferred to the microbiology laboratory within half an hour after rinsing for detection of bacterial counts. These samples were incubated 48-96 hours at 37°C. Number of bacterial colonies were counted by hand-held digital colony counter.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shmas University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:• Age 5-8 years.

• No history of systemic disease.
• Patients didn't received antibiotics for at least 3 months before and during the study

Exclusion Criteria:• Children who can't expectorate completely or brush their teeth on their own.

• Fixed or removable orthodontic appliances.
• Children with intra oral abscess, oral lesions or gingival diseases.
• Parental consent was not acquired

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Green tea extract mouth rinse; group green tea extract	Procedure: Green tea extract mouth rinse; herbal extracts mouth rinse that was prepared in the microbiology laboratory
Experimental: Garlic with lime extract mouth rinse; garlic with lime extract	Procedure: Garlic with lime extract mouth rinse; herbal extracts mouth rinse that was prepared in the microbiology laboratory
Experimental: Pomegranate extract mouth rinse; pomegranate extract	Procedure: Pomegranate extract mouth rinse; herbal extracts mouth rinse that was prepared in the microbiology laboratory
Experimental: Chlorhexidine mouth rinse; chlorhexidine	Procedure: Chlorhexidine mouth rinse; herbal extracts mouth rinse that was prepared in the microbiology laboratory

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction	Child satisfaction was measured using a 5-point pictorial likert scale .This Facial image scale was suitable and easy way to evaluate patient satisfaction about taste, smell and willing to use the mouth rinse. Its format was graded from 1 to 5 while 1 is the most satisfied and 5 is the least satisfied	Through study completion, an average of 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bacterial count	counting of Colony forming units was done by hand- held digital colony counter	1 day after rinsing

Collaborators and Investigators

• Sponsor: omnia sayed

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2018
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Pomegranate; Green tea extract; Caries prevention; Garlic extract; herbal mouth rinses
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: PED18-8M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No