Clinical Trials Directory

Trials / Completed

CompletedNCT07536438

Option 4 Antibacterial Effect of Moringa Mouthwash in Children With Mixed Dentition Wearing Orthodontic Appliances

Microbiological Evaluation of Mornga Mouth Wash in Children With Mixed Dentition Wearing Removable Orthodontic Appliances: A Randomized Controlled Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Al-Azhar University · Academic / Other
Sex
All
Age
8 Years – 12 Years
Healthy volunteers
Accepted

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

Detailed description

Oral diseases, such as gingivitis and dental caries, remain among the most prevalent public health issues worldwide despite significant advancements in dentistry. Children and adolescents are commonly affected by various periodontal conditions, including gingivitis, periodontitis, and periodontal diseases linked to systemic disorders. Epidemiological studies indicate that gingivitis of varying severity is widespread in this populatio. Removable orthodontic appliances provide favorable environments for pathogenic microorganisms due to biofilm accumulation on their surfaces and retentive sites like clamps, elastomeric rings, wires, and acrylic bases. The introduction of these devices creates new retentive areas in the oral cavity that facilitate bacterial adherence and biofilm growth . Oral microorganisms can be classified by their biological characteristics and location. The supragingival biofilm comprises six main microbial groups: red, orange, yellow, green, and purple complexes, along with the Actinomyces group and cariogenic species. Among these, the red and orange complexes are strongly associated with periodontal disease . The bacterial microflora plays a crucial role in maintaining oral health by preventing colonization of potentially pathogenic exogenous microorganisms and regulating the host's inflammatory response to commensal bacteria . Previous studies provide moderate-to-high evidence that orthodontic appliances significantly alter oral microbiota composition, particularly increasing Streptococcus mutans (S. mutans) and Lactobacilli levels. Moreover, many children wearing removable orthodontic appliances exhibit imperfect oral hygiene compliance, often due to limited manual dexterity. Therefore, auxiliary antimicrobial agents are clinically recommended to control microbial contamination of these appliances and reduce the risk of dental caries and periodontal disease during orthodontic treatment . Although mechanical cleaning remains the gold standard for preventing microbial colonization in the oral cavity, its effectiveness can be compromised by patient compliance, improper technique, and the complexity of appliances or prostheses. Consequently, chemotherapeutic agents are often advised to support oral hygiene and provide antibacterial effects . Herbal mouthwashes and toothpaste have gained popularity for their beneficial effects on dental health. Several herbal products exhibit antibacterial properties that inhibit acid production by cariogenic bacteria and limit plaque formation . Among herbal options, Moringa oleifera is notable for its rich composition of bioactive phytochemicals, including phenolic acids, flavonoids, alkaloids, phytosterols, vitamins, minerals, and organic acids. It is also a significant source of antioxidants such as tocopherols, carotenoids, polyunsaturated fatty acids, ascorbic acid, and folate . Importantly, Moringa oleifera contains saponins, terpenoids, and alkaloids with anti-inflammatory effects. These compounds modulate transcription factors like nuclear factor kappa B (NF-kB) and nuclear factor erythroid-derived 2, which are implicated in the pathogenesis of chronic inflammatory diseases such as periodontitis . This study will be performed to evaluate the microbiological effects of Moringa mouthwash on Streptococcus and Lactobacillus bacteria in children with mixed dentition who are wearing removable

Conditions

Interventions

TypeNameDescription
OTHERMoringa mouthwashHerbal mouthwash prepared from Moringa extract used daily to evaluate its effect on oral microflora in children.
BEHAVIORALOral Hygiene RoutineStandard oral hygiene practices including tooth brushing instructions followed by participants.

Timeline

Start date
2025-07-28
Primary completion
2026-03-01
Completion
2026-03-30
First posted
2026-04-17
Last updated
2026-04-17

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT07536438. Inclusion in this directory is not an endorsement.