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Completed

NCT Number: NCT07536438

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

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

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Key information

Conditions

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar University - Faculty of Dentistry for Girls

Cairo, Cairo Governorate, 11528, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

The inclusion criteria are :

  • Age from 8 to 12 years old.
  • Both sexes.
  • Children with mixed dentition wear removable orthodontic appliances. The exclusion criteria are :
  • 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.

Treatment and study plan

Moringa mouthwash

Other

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

Oral Hygiene Routine

Behavioral

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

Primary outcomes

  1. Salivary Streptococcus mutans and Lactobacillus counts

    Time frame: Baseline, 1 week, 1 month after intervention

    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.

  2. Change in Oral Microbial Count

    Time frame: 4 weeks

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

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Acronym: MOR-MW

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.