MedDataX Logo

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

NCT ID: NCT05623605

Last Updated: 2022-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Caries in Children

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Moringa Star Anis Indian Costus Mouth wash Streptococus Mutans

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
blinded

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

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

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Meet the organizations funding or collaborating on the study and learn about their roles.

Nahda University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

GHada Abdelwahab Ahmed

Associate Professor of Pediatric Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mariem Elmansy, Ph.D

Role: STUDY_CHAIR

researcher

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ghada Salem

Maadi, Cairo Governorate, Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ghada Salem, Ass. Professor

Role: CONTACT

Phone: +201005144561

Email: [email protected]

Mohamed Rashed, Ph.D

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ghada Salem, Ph.D

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

040522

Identifier Type: -

Identifier Source: org_study_id