- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07536438
Antibacterial Effect of Moringa Mouthwash in Children With Mixed Dentition Wearing Orthodontic Appliances (MOR-MW)
Microbiological Evaluation of Mornga Mouth Wash in Children With Mixed Dentition Wearing Removable Orthodontic Appliances: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypt, 11528
- Al-Azhar University - Faculty of Dentistry for Girls
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Moringa Mouthwash Group
Participants in this group used Moringa mouthwash daily in addition to standard oral hygiene practices to evaluate its effect on oral microflora.
|
Herbal mouthwash prepared from Moringa extract used daily to evaluate its effect on oral microflora in children.
|
|
Active Comparator: Control Group
Participants followed standard oral hygiene routine without the use of Moringa mouthwash
|
Standard oral hygiene practices including tooth brushing instructions followed by participants.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 1 week, 1 month after intervention
|
|
Change in Oral Microbial Count
Time Frame: 4 weeks
|
Reduction in the bacterial load of Streptococcus and Lactobacillus in the oral cavity.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mohamed Hassan Mostafa, Associate Professor, Al-Azhar University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ID P-PE-25-04
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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