Evaluation of New Different Herbal Mouthwashes Against Caries Forming Bacteria, RCT

Dental Caries in Children Clinical Trial

Official title:

Evaluation of Antibacterial Potency of New Different Herbal Mouthwashes Against Caries Forming Bacteria, a Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05623605
• Other study ID #: 040522
• Status: Recruiting
• Phase: Phase 4
• Start date: June 19, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: December 2022
• Source: Nahda University
• Contact: Ghada Salem, Ass. Professor
• Phone: +201005144561
• Email: ghada.abdelwahab[@]nub.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this randomized controlled trial is to compare three different types of mouthwash, Moringa, Star anis, and Indian Costus 90 children participated in this study divided into 3 groups according to the type of mouthwash used and then subdivided in each group into 3 subgroups according to the concentration of the mouthwash 5,10,15%. the children were asked to rinse with the mouthwash 3 times per day for 1 week. bacterial count for streptococcus mutans was measured before and after the use of mouthwash to see the most effective concentration.

Description:

The powdered of Moringa, Star anis, and Indian Costus leaves (250 g) were extracted using 90% ethanol then filtered using Whatman Filter paper No.1 and dried under reduced pressure using rota vapor. The crude ethanolic extract was (200 mg). ninety children will be randomly distributed into three groups (1,2,3) (30 children each). each group was divided into further 3 groups (10 children each) according to the concentration of each herbal mouthwash (5,10,15%). each participant will be given a new bottle of a specific effective amount of herbal extract to be used as a mouthwash. Children will be instructed to rinse with 5ml of mouthwash. All groups were instructed to rinse three times a day with specific mouthwash for each group for about one minute and participants will be advised to use the mouthwash for seven days. Collection of saliva samples Prior to the start of the experiment, samples of unstimulated saliva were taken when the child spit a suitable amount of unstimulated saliva in a sterile container in the morning before breakfast. Initial salivary samples were collected to establish base levels (S1) using selective culture media, The salivary samples (S2) were collected after one week of using the mouthwash when the child spit a suitable amount of unstimulated saliva in a sterile container in the morning before breakfast.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 30, 2022
• Est. primary completion date: December 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• - Children with no systemic disease, no history of recent antibiotic administration (last 2 weeks), antimicrobial mouth-rinse (last 12 hours), topical fluoride treatment within 4 weeks prior to baseline, children with no untreated active carious lesion, no orthodontic appliance or with low caries index (DMF& def < 4)

Exclusion Criteria:

• Children using antibiotics, medications or mouthwashes at the time of the study, children with oral or systemic disease, children undergoing any dental treatment

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

Drug:
• Moringa mouthwash
using Moringa mouthwashes in 3 different concentrations (5,10,15%) twice per day for 7 days
• star anise mouthwash
using star anise mouthwash in 3 different concentrations (5,10,15%) twice per day for 7 days
• Indian costus mouth wash
using Indian costus mouthwash in 3 different concentrations (5,10,15%) twice per day for 7 days

Locations

Country	Name	City	State
Egypt	Ghada Salem	Maadi	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Nahda University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bacterial count	decrease the count of streptococus mutans after use of the herbal mouthwash	1 weak