Oral Microbial LoadMOR-MWNCT07536438
Antibacterial Effect of Moringa Mouthwash in Children With Mixed Dentition Wearing Orthodontic Appliances
A study testing Moringa mouthwash and Oral Hygiene Routine in people with Oral Microbial Load, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Microbial Load
- What is being tested?
- Moringa mouthwash and Oral Hygiene Routine
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jul 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Al-Azhar University - Faculty of Dentistry for Girls
Cairo, Cairo Governorate, 11528
About this study
Official title: Microbiological Evaluation of Mornga Mouth Wash in Children With Mixed Dentition Wearing Removable Orthodontic Appliances: A Randomized Controlled Study
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
Read the 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
- Oral Microbial Load
- Being tested
- Moringa mouthwash, Oral Hygiene Routine
- Keywords
- salivary microbiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moringa mouthwashOther
Herbal mouthwash prepared from Moringa extract used daily to evaluate its effect on oral microflora in children.
Oral Hygiene RoutineBehavioural
Standard oral hygiene practices including tooth brushing instructions followed by participants.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Moringa mouthwash |
| Control Group | Active comparator | Participants followed standard oral hygiene routine without the use of Moringa mouthwash Receives: Behavioral: Oral Hygiene Routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start28 Jul 2025
- Primary completion1 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Microbial LoadStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sumaia Saleh Ahmed Alilay, Al-Azhar University
- Investigators
- Mohamed Hassan Mostafa, Associate Professor, Study director, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536438
- Sponsor's protocol ID
- ID P-PE-25-04
- Acronym
- MOR-MW
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiological Evaluation of Mornga Mouth Wash in Children With Mixed Dentition Wearing Removable Orthodontic Appliances: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07536438
- Acronym / sponsor ID
- MOR-MW / ID P-PE-25-04
- Conditions
- Oral Microbial Load
- Keywords
- salivary microbiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Moringa Mouthwash Group | Experimental | Other: Moringa mouthwashParticipants in this group used Moringa mouthwash daily in addition to standard oral hygiene practices to evaluate its effect on oral microflora. |
| Control Group | Active comparator | Behavioral: Oral Hygiene RoutineParticipants followed standard oral hygiene routine without the use of Moringa mouthwash |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moringa mouthwashHerbal mouthwash prepared from Moringa extract used daily to evaluate its effect on oral microflora in children. | Other | Moringa Mouthwash Group |
| Oral Hygiene RoutineStandard oral hygiene practices including tooth brushing instructions followed by participants. | Behavioural | Control Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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Carious Lesion, Ready-made Crowns
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Hassan Mostafa, Associate Professor study director
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moringa mouthwash and Oral Hygiene Routine in people with Oral Microbial Load, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary Streptococcus mutans and Lactobacillus counts (time frame: Baseline, 1 week, 1 month after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.