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

NCT05623605 | Unknown Phase 4

• 1 other identifier: 040522
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries in Children

Keywords

Moringa; Star Anis; Indian Costus; Mouth wash; Streptococus Mutans

Outcome Measures

Primary Outcomes (1)

• bacterial count

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

  1 weak

Study Arms (3)

Moringa mouthwash

EXPERIMENTAL

5 ml Moringa mouthwash two times per day for 1 week

Drug: Moringa mouthwash

Star Anis mouthwash

EXPERIMENTAL

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

Drug: star anise mouthwash

Indian Costus mouthwash

EXPERIMENTAL

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

Drug: Indian costus mouth wash

Interventions

Moringa mouthwash DRUG

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

Also known as: Moringa herbal mouthwash

Moringa mouthwash

star anise mouthwash DRUG

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

Also known as: star anise herbal mouthwash

Star Anis mouthwash

Indian costus mouth wash DRUG

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

Also known as: Indian costus herbal mouth wash

Indian Costus mouthwash

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- 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)

You may not qualify if:

• Children using antibiotics, medications or mouthwashes at the time of the study, children with oral or systemic disease, children undergoing any dental treatment

Sponsors & Collaborators

• Nahda University: lead

Study Sites (1)

Ghada Salem

Maadi, Cairo Governorate, 11728, Egypt

RECRUITING

Study Officials

• Mariem Elmansy, Ph.D

  researcher

  STUDY CHAIR

Central Study Contacts

Ghada Salem, Ass. Professor

CONTACT

+201005144561; ghada.abdelwahab@nub.edu.eg

Mohamed Rashed, Ph.D

CONTACT

mf.helal@nrc.sci.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatric Dentistry

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 12, 2022
• First Posted: November 21, 2022
• Study Start: June 19, 2022
• Primary Completion: December 13, 2022
• Study Completion: December 30, 2022
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)