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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)

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Green tea extract mouth rinse
Garlic with lime extract mouth rinse
Pomegranate extract mouth rinse
Chlorhexidine mouth rinse
Sponsored by
omnia sayed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring herbal mouth rinses, Pomegranate, Caries prevention, Garlic extract, Green tea extract

Eligibility Criteria

5 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ain Shmas University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Green tea extract mouth rinse

Garlic with lime extract mouth rinse

Pomegranate extract mouth rinse

Chlorhexidine mouth rinse

Arm Description

group green tea extract

garlic with lime extract

pomegranate extract

chlorhexidine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

bacterial count
counting of Colony forming units was done by hand- held digital colony counter

Full Information

First Posted
March 27, 2023
Last Updated
May 2, 2023
Sponsor
omnia sayed
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1. Study Identification

Unique Protocol Identification Number
NCT05841589
Brief Title
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)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 21, 2018 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
omnia sayed

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
herbal mouth rinses, Pomegranate, Caries prevention, Garlic extract, Green tea extract

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
the four groups of the mouth rinses were done in parallel with each other
Masking
ParticipantOutcomes Assessor
Masking Description
the participant didn't know what he rinsed with the prescribed group of mouth rinse. the outcome assessor didn't know what group of mouth rinse belong to the bacterial count that was evaluated.
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Green tea extract mouth rinse
Arm Type
Experimental
Arm Description
group green tea extract
Arm Title
Garlic with lime extract mouth rinse
Arm Type
Experimental
Arm Description
garlic with lime extract
Arm Title
Pomegranate extract mouth rinse
Arm Type
Experimental
Arm Description
pomegranate extract
Arm Title
Chlorhexidine mouth rinse
Arm Type
Experimental
Arm Description
chlorhexidine
Intervention Type
Procedure
Intervention Name(s)
Green tea extract mouth rinse
Intervention Description
herbal extracts mouth rinse that was prepared in the microbiology laboratory
Intervention Type
Procedure
Intervention Name(s)
Garlic with lime extract mouth rinse
Intervention Description
herbal extracts mouth rinse that was prepared in the microbiology laboratory
Intervention Type
Procedure
Intervention Name(s)
Pomegranate extract mouth rinse
Intervention Description
herbal extracts mouth rinse that was prepared in the microbiology laboratory
Intervention Type
Procedure
Intervention Name(s)
Chlorhexidine mouth rinse
Intervention Description
herbal extracts mouth rinse that was prepared in the microbiology laboratory
Primary Outcome Measure Information:
Title
patient satisfaction
Description
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
Time Frame
Through study completion, an average of 1 month
Secondary Outcome Measure Information:
Title
bacterial count
Description
counting of Colony forming units was done by hand- held digital colony counter
Time Frame
1 day after rinsing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ain Shmas University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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)

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