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Clinical Trials/NCT07536438
NCT07536438
Completed
Not Applicable

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

Al-Azhar University1 site in 1 country60 target enrollmentStarted: July 28, 2025Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Salivary Streptococcus mutans and Lactobacillus counts

Overview

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

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Masking Description

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).

Eligibility Criteria

Ages
8 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Arms & Interventions

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.

Intervention: Moringa mouthwash (Other)

Control Group

Active Comparator

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

Intervention: Oral Hygiene Routine (Behavioral)

Outcomes

Primary Outcomes

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.

Change in Oral Microbial Count

Time Frame: 4 weeks

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sumaia Saleh Ahmed Alilay

Postgraduate Student in Pediatric Dentistry

Al-Azhar University

Study Sites (1)

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