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临床试验/NCT07826390
NCT07826390尚未招募不适用

Effectiveness of Coconut Oil Pulling and Moringa Mouthwash Versus Chlorhexidine in Reducing Gingivitis in Diabetic Children: A Randomized Controlled Pilot Study

Amira Yehia Zakaria1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Gingival Health

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age from 6 to 12 years.
  • Both males and females.
  • Diabetic Children with mild to moderate gingivitis.
  • Medically stable, without other systemic conditions affecting oral health.
  • Written informed consent obtained from parents or legal guardians and assent from the child.

排除标准

  • Severe gingival or periodontal disease
  • Hypersensitivity or allergy to coconut oil, moringa, chlorhexidine, or any component of the study interventions.
  • Presence of systemic conditions other than diabetes that may affect results
  • Antibiotics use, corticosteroids, that may influence gingival health within the past 4 weeks.

研究组 & 干预措施

Chlorhexidine mouthwash

Active Comparator

0.12% chlorhexidine mouthwash will be used for Swishing for 1 minute once daily for 4 weeks

干预措施: Moringa olfera mouthwash (Other)

Chlorhexidine mouthwash

Active Comparator

0.12% chlorhexidine mouthwash will be used for Swishing for 1 minute once daily for 4 weeks

干预措施: coconut oil pulling (Other)

Coconut oil pulling

Experimental

Oil pulling with 5 mL of virgin coconut oil will be used for swishing for 1 minute once daily under parental supervision.

干预措施: Chlorhexidine mouthwash (Other)

Moringa olfera mouthwash

Experimental

Children will swish aqueous extract preparation from moringa leaves for 1 minute daily for 4 weeks

干预措施: Chlorhexidine mouthwash (Other)

结局指标

主要结局

Gingival Health

时间窗: baseline before treatment, immediately after, after 2 weeks and after 4 weeks.

Clinical examination using the Gingival Index

次要结局

  • Porphyromonas gingivalis count(baseline before treatment, immediately after, after 2 weeks and after 4 weeks.)

研究者

发起方
Amira Yehia Zakaria
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Amira Yehia Zakaria

pediatric dentist

Cairo University

研究点 (1)

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