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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Caries in Children
• Intervention / Treatment: Drug: Moringa mouthwash; Drug: star anise mouthwash; Drug: Indian costus mouth wash

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ghada Salem, Ass. Professor; Phone Number: +201005144561; Email: ghada.abdelwahab@nub.edu.eg
• Study Contact Backup: Name: Mohamed Rashed, Ph.D; Email: mf.helal@nrc.sci.eg

Study Locations

• Egypt
  • Cairo
    • Maadi, Cairo, Egypt, 11728
      • Recruiting
      • Ghada Salem
      • Contact: Ghada Salem, Ph.D; Phone Number: +201005144561; Email: ghadamohamedalirana@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bacterial count	decrease the count of streptococus mutans after use of the herbal mouthwash	1 weak

Collaborators and Investigators

• Sponsor: Nahda University
• Investigators: Study Chair: Mariem Elmansy, Ph.D, Researcher

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2022
• Primary Completion (Anticipated): December 13, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: November 12, 2022
• First Submitted That Met QC Criteria: November 18, 2022
• First Posted (Actual): November 21, 2022

Study Record Updates

• Last Update Posted (Actual): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Moringa; Star Anis; Indian Costus; Mouth wash; Streptococus Mutans
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 040522

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No