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)

Sponsor

omnia sayed (Other)

Overall Status

Completed

CT.gov ID

NCT05841589

Collaborator

(none)

Enrollment

Location

Arms

45.3

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Procedure: Green tea extract mouth rinse Procedure: Garlic with lime extract mouth rinse Procedure: Pomegranate extract mouth rinse Procedure: Chlorhexidine mouth rinse	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

the four groups of the mouth rinses were done in parallel with each otherthe four groups of the mouth rinses were done in parallel with each other

Masking:

Double (Participant, Outcomes 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.

Primary Purpose:

Prevention

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)

Actual Study Start Date :

Feb 21, 2018

Actual Primary Completion Date :

Nov 30, 2021

Actual Study Completion Date :

Dec 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

patient satisfaction [Through study completion, an average of 1 month]
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 [1 day after rinsing]
counting of Colony forming units was done by hand- held digital colony counter

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 8 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shmas University	Cairo		Egypt

Sponsors and Collaborators

omnia sayed

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

omnia sayed, Principal investigator and demonstrator at Pediatric Dentistry & Dental Public Health Department, Ain Shams University

ClinicalTrials.gov Identifier:

NCT05841589

Other Study ID Numbers:

PED18-8M

First Posted:

May 3, 2023

Last Update Posted:

May 3, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by omnia sayed, Principal investigator and demonstrator at Pediatric Dentistry & Dental Public Health Department, Ain Shams University

Additional relevant MeSH terms:

Dental Caries

Chlorhexidine

Study Results

No Results Posted as of May 3, 2023