An interventional study of Chlorhexidine mouthwash and Moringa olfera mouthwash in Reducing Gingivitis and Clinical Effect, sponsored by Amira Yehia Zakaria. Not yet recruiting at 1 site in Egypt. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Amira Yehia Zakaria · Not applicable, Interventional, and Treatment
Gingivitis is a common and reversible inflammatory condition, mainly caused by dental plaque, and is particularly prevalent among children. Children with diabetes mellitus are more susceptible because of altered immune responses, impaired healing, and changes in the oral microbiota.
Although mechanical plaque control is the primary method of prevention, poor oral hygiene compliance in children highlights the need for safe adjunctive treatments. Chlorhexidine, while highly effective, can cause staining, taste alteration, and mucosal irritation, limiting its long term pediatric use.
Natural alternatives such as coconut oil and Moringa oleifera have attracted attention because of their antimicrobial, anti-inflammatory, and antioxidant properties. Coconut oil, particularly its lauric acid content, may reduce oral pathogens, plaque, and gingival inflammation. Moringa contains bioactive compounds such as flavonoids, phenolic acids, and isothiocyanates that may help reduce inflammation, oxidative stress, and microbial load.
However, comparative clinical evidence on coconut oil versus Moringa for managing gingivitis in diabetic children remains limited, highlighting the need for further clinical research to determine their safety and effectiveness in this vulnerable population.
Gingivitis represents one of the most prevalent inflammatory diseases affecting the gingival tissues and remains a major public health concern worldwide, particularly among pediatric populations. It is primarily induced by dental plaque biofilm accumulation along the gingival margin, resulting in gingival inflammation characterized by redness, swelling, bleeding on probing, and discomfort. Although gingivitis is considered a reversible condition, if left untreated, it may progress to periodontitis, leading to irreversible destruction of periodontal supporting structures and eventual tooth loss.
Children with systemic conditions, especially diabetes mellitus, exhibit a higher susceptibility to gingival inflammation due to altered immune responses, impaired wound healing, and changes in oral microbial flora.
Mechanical plaque control through tooth brushing and professional prophylaxis remains the cornerstone of gingivitis prevention and management. However, compliance with routine oral hygiene practices among children is often suboptimal. Therefore, adjunctive therapeutic agents with antimicrobial and anti-inflammatory properties have gained increasing attention. Chlorhexidine mouthwash is widely considered the gold standard chemical plaque control agent; nevertheless, its long-term use is associated with adverse effects including tooth staining, taste alteration, and mucosal irritation, limiting its acceptability among pediatric patients. This has led to growing interest in exploring natural and herbal alternatives that are safe, cost-effective, and well tolerated. Coconut oil has recently gained popularity as a natural oral health agent, particularly through the practice of oil pulling, which is a traditional Ayurvedic technique involving swishing oil in the oral cavity. Coconut oil contains a high concentration of medium-chain fatty acids, predominantly lauric acid, which possesses potent antimicrobial, anti-inflammatory, and antioxidant properties. Lauric acid has demonstrated effectiveness against various oral pathogens, including Streptococcus mutans and Candida species, by disrupting microbial cell membranes and inhibiting biofilm formation. Additionally, coconut oil may reduce gingival inflammation by modulating inflammatory mediators and enhancing tissue healing. Several clinical studies have reported improvements in plaque and gingival indices following coconut oil use, suggesting its potential as a safe adjunctive therapy in managing gingivitis.
Moringa oleifera, commonly referred to as the "miracle tree," is another herbal product that has gained considerable attention for its medicinal and nutritional benefits. It is rich in bioactive compounds including flavonoids, phenolic acids, vitamins, minerals, and essential amino acids. Moringa extracts exhibit strong antimicrobial activity against a broad spectrum of oral microorganisms and possess significant anti-inflammatory and antioxidant effects. These properties are primarily attributed to phytochemicals such as quercetin, chlorogenic acid, and isothiocyanates, which reduce oxidative stress and suppress inflammatory pathways. Recent experimental and clinical studies have suggested that moringa based formulations may improve periodontal health by reducing plaque accumulation, gingival inflammation, and microbial load, making it a promising natural therapeutic agent.
Despite the documented therapeutic potential of coconut oil and moringa individually, comparative clinical studies evaluating their effectiveness in reducing gingivitis, particularly among diabetic children, remain limited. Pediatric diabetic patients constitute a vulnerable group requiring safe, well-tolerated, and effective adjunctive oral health interventions. Natural herbal agents such as coconut oil and moringa may provide affordable and culturally acceptable alternatives, especially in developing countries where access to conventional dental care may be limited.
631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's planned enrollment of 30 is below the median of 66 across 507 interventional studies indexed under Gingivitis.
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Exclusion Criteria:
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children will swish aqueous extract preparation from moringa leaves for 1 minute daily for 4 weeks
Other: Chlorhexidine mouthwash
Oil pulling with 5 mL of virgin coconut oil will be used for swishing for 1 minute once daily under parental supervision.
Other: Chlorhexidine mouthwash
0.12% chlorhexidine mouthwash will be used for Swishing for 1 minute once daily for 4 weeks
Other: Moringa olfera mouthwash · Other: coconut oil pulling
Active comparator
Intervetion
Intervention
Gingival Health
Clinical examination using the Gingival Index Score 0-3 where: 0 Normal gingiva; no inflammation 1. Mild inflammation: slight change in color and slight edema; no bleeding on probing 2. Moderate inflammation: redness, edema, and glazing; bleeding on probing 3. Severe inflammation: marked redness and edema, ulceration, and spontaneous bleeding
Time frame: baseline immediately after week 2 week 4.
Porphyromonas gingivalis count
Microbiological analysis manual colony counting using agar
Time frame: baseline immediately after week 2 week 4
Patient Acceptability
1-5 Likert scale questionnaire is a survey where people rate their level of agreement with a statement using five choices where: 1. Strongly Disagree 2. Disagree 3. Neutral / Neither Agree nor Disagree 4. Agree 5. Strongly Agree
Time frame: baseline immediately after week 2 week 4
Patient compliance
self-reported adherence using the Modified Morisky Medication Adherence Scale The questionnaire has 4 yes/no questions about medication taking behavior. Each answer is scored 0 or 1, giving a total score from 0 to 4. Where: 0 High adherence 1-2 Medium adherence 3-4 Low adherence
Time frame: week 2 week 4
Plan to share: Yes — supporting information
Supporting information: Study protocol, Informed consent form
Time frame: 4 weeks
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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