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

Sponsor

Nahda University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05623605

Collaborator

(none)

Enrollment

Location

Arms

6.4

Anticipated Duration (Months)

14.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries in Children	Drug: Moringa mouthwash Drug: star anise mouthwash Drug: Indian costus mouth wash	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trialRandomized controlled trial

Masking:

Single (Participant)

Masking Description:

blinded

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 19, 2022

Anticipated Primary Completion Date :

Dec 13, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Moringa mouthwash 5 ml Moringa mouthwash two times per day for 1 week	Drug: Moringa mouthwash using Moringa mouthwashes in 3 different concentrations (5,10,15%) twice per day for 7 days Other Names: Moringa herbal mouthwash
Experimental: Star Anis mouthwash 5 ml Star Anis mouthwash two times per day for 1 week	Drug: star anise mouthwash using star anise mouthwash in 3 different concentrations (5,10,15%) twice per day for 7 days Other Names: star anise herbal mouthwash
Experimental: Indian Costus mouthwash 5 ml Indian Costus mouthwash two times per day for 1 week	Drug: Indian costus mouth wash using Indian costus mouthwash in 3 different concentrations (5,10,15%) twice per day for 7 days Other Names: Indian costus herbal mouth wash

Arm

Intervention/Treatment

Experimental: Moringa mouthwash

5 ml Moringa mouthwash two times per day for 1 week

Drug: Moringa mouthwash

using Moringa mouthwashes in 3 different concentrations (5,10,15%) twice per day for 7 days

Other Names:

Moringa herbal mouthwash

Experimental: Star Anis mouthwash

5 ml Star Anis mouthwash two times per day for 1 week

Drug: star anise mouthwash

using star anise mouthwash in 3 different concentrations (5,10,15%) twice per day for 7 days

Other Names:

star anise herbal mouthwash

Experimental: Indian Costus mouthwash

5 ml Indian Costus mouthwash two times per day for 1 week

Drug: Indian costus mouth wash

using Indian costus mouthwash in 3 different concentrations (5,10,15%) twice per day for 7 days

Other Names:

Indian costus herbal mouth wash

Outcome Measures

Primary Outcome Measures

bacterial count [1 weak]
decrease the count of streptococus mutans after use of the herbal mouthwash

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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