NCT07536438

Brief Summary

This randomized controlled study aims to evaluate the microbiological effectiveness of Moringa mouthwash in children with mixed dentition wearing removable orthodontic appliances. The study compares Moringa mouthwash with a control mouthwash in reducing oral microbial load and improving oral hygiene. Children will be followed for a specified period, and microbiological samples will be collected and analyzed to assess changes in bacterial levels

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 28, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

April 11, 2026

Last Update Submit

April 18, 2026

Conditions

Keywords

salivary microbiology

Outcome Measures

Primary Outcomes (2)

  • Salivary Streptococcus mutans and Lactobacillus counts

    Salivary samples will be collected from children wearing removable orthodontic appliances at baseline and after the intervention period. The samples will be microbiologically analyzed to determine the colony-forming units (CFU/mL) of Streptococcus mutans and Lactobacillus spp. using standard culture methods. Changes in bacterial counts before and after using moringa mouthwash will be used to evaluate its antimicrobial effect.

    Baseline, 1 week, 1 month after intervention

  • Change in Oral Microbial Count

    Reduction in the bacterial load of Streptococcus and Lactobacillus in the oral cavity.

    4 weeks

Study Arms (2)

Moringa Mouthwash Group

EXPERIMENTAL

Participants in this group used Moringa mouthwash daily in addition to standard oral hygiene practices to evaluate its effect on oral microflora.

Other: Moringa mouthwash

Control Group

ACTIVE COMPARATOR

Participants followed standard oral hygiene routine without the use of Moringa mouthwash

Behavioral: Oral Hygiene Routine

Interventions

Herbal mouthwash prepared from Moringa extract used daily to evaluate its effect on oral microflora in children.

Moringa Mouthwash Group

Standard oral hygiene practices including tooth brushing instructions followed by participants.

Control Group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age from 8 to 12 years old.
  • Both sexes.

You may not qualify if:

  • Children suffering from systemic illness.
  • Children who are previously using mouthwashes.
  • Oral prophylaxis history within the previous six months.
  • Chronic periodontitis.
  • Presence of other prosthetic rehabilitations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University - Faculty of Dentistry for Girls

Cairo, Cairo Governorate, 11528, Egypt

Location

Study Officials

  • Mohamed Hassan Mostafa, Associate Professor

    Al-Azhar University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study. Participants and investigators are aware of the assigned interventions due to the nature of the study (mouthwash versus standard oral hygiene routine).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned into two parallel groups. One group will use Moringa mouthwash, while the control group will follow a standard oral hygiene routine. The effect on oral microflora will be assessed over the study period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate Student in Pediatric Dentistry

Study Record Dates

First Submitted

April 11, 2026

First Posted

April 17, 2026

Study Start

July 28, 2025

Primary Completion

March 1, 2026

Study Completion

March 30, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations