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

Primary Purpose

Dental Caries in Children

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Moringa mouthwash
star anise mouthwash
Indian costus mouth wash
Sponsored by
Nahda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries in Children focused on measuring Moringa, Star Anis, Indian Costus, Mouth wash, Streptococus Mutans

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ghada SalemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Moringa mouthwash

Star Anis mouthwash

Indian Costus mouthwash

Arm Description

5 ml Moringa mouthwash two times per day for 1 week

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

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

Outcomes

Primary Outcome Measures

bacterial count
decrease the count of streptococus mutans after use of the herbal mouthwash

Secondary Outcome Measures

Full Information

First Posted
November 12, 2022
Last Updated
December 12, 2022
Sponsor
Nahda University
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1. Study Identification

Unique Protocol Identification Number
NCT05623605
Brief Title
Evaluation of New Different Herbal Mouthwashes Against Caries Forming Bacteria, RCT
Official Title
Evaluation of Antibacterial Potency of New Different Herbal Mouthwashes Against Caries Forming Bacteria, a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2022 (Actual)
Primary Completion Date
December 13, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nahda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries in Children
Keywords
Moringa, Star Anis, Indian Costus, Mouth wash, Streptococus Mutans

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Participant
Masking Description
blinded
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Moringa mouthwash
Arm Type
Experimental
Arm Description
5 ml Moringa mouthwash two times per day for 1 week
Arm Title
Star Anis mouthwash
Arm Type
Experimental
Arm Description
5 ml Star Anis mouthwash two times per day for 1 week
Arm Title
Indian Costus mouthwash
Arm Type
Experimental
Arm Description
5 ml Indian Costus mouthwash two times per day for 1 week
Intervention Type
Drug
Intervention Name(s)
Moringa mouthwash
Other Intervention Name(s)
Moringa herbal mouthwash
Intervention Description
using Moringa mouthwashes in 3 different concentrations (5,10,15%) twice per day for 7 days
Intervention Type
Drug
Intervention Name(s)
star anise mouthwash
Other Intervention Name(s)
star anise herbal mouthwash
Intervention Description
using star anise mouthwash in 3 different concentrations (5,10,15%) twice per day for 7 days
Intervention Type
Drug
Intervention Name(s)
Indian costus mouth wash
Other Intervention Name(s)
Indian costus herbal mouth wash
Intervention Description
using Indian costus mouthwash in 3 different concentrations (5,10,15%) twice per day for 7 days
Primary Outcome Measure Information:
Title
bacterial count
Description
decrease the count of streptococus mutans after use of the herbal mouthwash
Time Frame
1 weak

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ghada Salem, Ass. Professor
Phone
+201005144561
Email
ghada.abdelwahab@nub.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Rashed, Ph.D
Email
mf.helal@nrc.sci.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariem Elmansy, Ph.D
Organizational Affiliation
researcher
Official's Role
Study Chair
Facility Information:
Facility Name
Ghada Salem
City
Maadi
State/Province
Cairo
ZIP/Postal Code
11728
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghada Salem, Ph.D
Phone
+201005144561
Email
ghadamohamedalirana@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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