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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05841589
Other study ID # PED18-8M
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 21, 2018
Est. completion date December 1, 2021

Study information

Verified date April 2023
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date December 1, 2021
Est. primary completion date November 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 8 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Green tea extract mouth rinse
herbal extracts mouth rinse that was prepared in the microbiology laboratory
Garlic with lime extract mouth rinse
herbal extracts mouth rinse that was prepared in the microbiology laboratory
Pomegranate extract mouth rinse
herbal extracts mouth rinse that was prepared in the microbiology laboratory
Chlorhexidine mouth rinse
herbal extracts mouth rinse that was prepared in the microbiology laboratory

Locations

Country Name City State
Egypt Ain Shmas University Cairo

Sponsors (1)

Lead Sponsor Collaborator
omnia sayed

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 bacterial count counting of Colony forming units was done by hand- held digital colony counter 1 day after rinsing
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