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

NCT ID: NCT05623605

Last Updated: 2022-12-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-19
• Study Completion Date: 2022-12-30

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.

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.

Conditions

Dental Caries in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Moringa mouthwash

5 ml Moringa mouthwash two times per day for 1 week

Group Type: EXPERIMENTAL

Moringa mouthwash

Intervention Type: DRUG

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

Star Anis mouthwash

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

Group Type: EXPERIMENTAL

star anise mouthwash

Intervention Type: DRUG

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

Indian Costus mouthwash

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

Group Type: EXPERIMENTAL

Indian costus mouth wash

Intervention Type: DRUG

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

Interventions

Moringa mouthwash

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

Intervention Type: DRUG

star anise mouthwash

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

Intervention Type: DRUG

Indian costus mouth wash

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

Intervention Type: DRUG

Other Intervention Names

Moringa herbal mouthwash; star anise herbal mouthwash; Indian costus herbal mouth wash

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nahda University

OTHER

Sponsor Role: lead

Responsible Party

GHada Abdelwahab Ahmed

Associate Professor of Pediatric Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mariem Elmansy, Ph.D

Role: STUDY_CHAIR

researcher

Locations

Ghada Salem

Maadi, Cairo Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ghada Salem, Ass. Professor

Role: CONTACT

ghada.abdelwahab@nub.edu.eg

+201005144561

Mohamed Rashed, Ph.D

Role: CONTACT

mf.helal@nrc.sci.eg

Facility Contacts

Ghada Salem, Ph.D

Role: primary

ghadamohamedalirana@hotmail.com

+201005144561

Other Identifiers

040522

Identifier Type: -

Identifier Source: org_study_id