- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07826390
Effectiveness of Coconut Oil Pulling and Moringa Mouthwash Versus Chlorhexidine in Reducing Gingivitis in Diabetic Children
Effectiveness of Coconut Oil Pulling and Moringa Mouthwash Versus Chlorhexidine in Reducing Gingivitis in Diabetic Children: A Randomized Controlled Pilot Study
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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Amira Yehia Zakaria
- Номер телефона: +02 01226000741
- Электронная почта: amira.zakaria@dentistry.cu.edu.eg
Учебное резервное копирование контактов
- Имя: Nada Wassef, Proffesor
- Номер телефона: +02 01005074144
- Электронная почта: nada.wassef@dentistry.cu.edu.eg
Места учебы
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Cairo,Egypt
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Cairo, Cairo,Egypt, Египет, 11511
- Faculty of Dentistry Cairo University
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Moringa olfera mouthwash
Children will swish aqueous extract preparation from moringa leaves for 1 minute daily for 4 weeks
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Active comparator
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Экспериментальный: Coconut oil pulling
Oil pulling with 5 mL of virgin coconut oil will be used for swishing for 1 minute once daily under parental supervision.
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Active comparator
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Активный компаратор: Chlorhexidine mouthwash
0.12% chlorhexidine mouthwash will be used for Swishing for 1 minute once daily for 4 weeks
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Intervetion
Intervention
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Gingival Health
Временное ограничение: baseline before treatment, immediately after, after 2 weeks and after 4 weeks.
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Clinical examination using the Gingival Index
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baseline before treatment, immediately after, after 2 weeks and after 4 weeks.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Porphyromonas gingivalis count
Временное ограничение: baseline before treatment, immediately after, after 2 weeks and after 4 weeks.
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Microbiological analysis manual colony counting
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baseline before treatment, immediately after, after 2 weeks and after 4 weeks.
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Patient Acceptability
Временное ограничение: baseline before treatment, immediately after, after 2 weeks and after 4 weeks.
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5-point Likert scale questionnaire
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baseline before treatment, immediately after, after 2 weeks and after 4 weeks.
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Patient compliance
Временное ограничение: on week 2 and week 4
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self-reported adherence using the Modified Morisky Medication Adherence Scale
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on week 2 and week 4
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Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Общие публикации
- Peedikayil FC, Sreenivasan P, Narayanan A. Effect of coconut oil in plaque related gingivitis - A preliminary report. Niger Med J. 2015 Mar-Apr;56(2):143-7. doi: 10.4103/0300-1652.153406.
- Woolley J, Gibbons T, Patel K, Sacco R. The effect of oil pulling with coconut oil to improve dental hygiene and oral health: A systematic review. Heliyon. 2020 Aug 27;6(8):e04789. doi: 10.1016/j.heliyon.2020.e04789. eCollection 2020 Aug.
- 23. Zeeshan, A., Munir, M. & Sadia, S. 2024. Unlocking the promise of the "miracle tree: A review on therapeutic applications and phytochemistry of moringa oleifera l. J bioresour manag, 11, 18-22.
- Kamath NP, Tandon S, Nayak R, Naidu S, Anand PS, Kamath YS. The effect of aloe vera and tea tree oil mouthwashes on the oral health of school children. Eur Arch Paediatr Dent. 2020 Feb;21(1):61-66. doi: 10.1007/s40368-019-00445-5. Epub 2019 May 20.
- Van der Weijden GAF, van Loveren C. Mechanical plaque removal in step-1 of care. Periodontol 2000. 2023 Dec 26. doi: 10.1111/prd.12541. Online ahead of print.
- 20. Srivastava, A., Bhatt, N., Raghunath, V., Bhatt, S., Tekam, D. A. & Sagar, S. 2025. Herbal dentistry: A comprehensive review. JAMDSR 13, 1-5.
- Shafiq NE, Mahdee AF. Moringa oleifera Use in Maintaining Oral Health and Its Potential Use in Regenerative Dentistry. ScientificWorldJournal. 2023 Oct 17;2023:8876189. doi: 10.1155/2023/8876189. eCollection 2023.
- Rao W, Hussain M, Naseem N, Siddiqui WA. The intricacies of advanced glycation end products (AGEs) in diabetic neuropathy. 3 Biotech. 2026 Jan;16(1):24. doi: 10.1007/s13205-025-04652-4. Epub 2025 Dec 8.
- 17. Priya, R., Kaur, N., Rawat, A., Sharma, V., Bhalla, M. & Gupta, R. 2023. Effect of coconut oil pulling on plaque-induced gingivitis: A prospective clinical study. J Indian Assoc Public Health Dent, 21, 238-41.
- Pardinas Lopez S, Garcia-Caro ME, Vallejo JA, Aja-Macaya P, Conde-Perez K, Nion-Cabeza P, Khouly I, Bou G, Cendal AIR, Diaz-Prado S, Poza M. Anti-inflammatory and antimicrobial efficacy of coconut oil for periodontal pathogens: a triple-blind randomized clinical trial. Clin Oral Investig. 2025 Mar 14;29(4):182. doi: 10.1007/s00784-025-06267-8.
- 14. Nitbani, F. O., Tjitda, P. J. P., Nitti, F., Jumina, J. & Detha, A. I. R. 2022. Antimicrobial properties of lauric acid and monolaurin in virgin coconut oil: a review. ChemBioEng Rev, 9, 442-61.
- 13. Mohapatra, S., Mohandas, R., Rajpurohit, L. & Patil, S. 2024. Comparative evaluation of the efficacy of cetylpyridinium chloride mouthwash and chlorhexidine mouthwash in plaque reduction: A systematic review and meta-analysis. Curr Oral Health Rep, 12, 32-40.
- Maia MB, Souza JGS, Bertolini M, Costa RC, Costa GS, Torres SAS, Ferreira EF, Martins AMEBL. Knowledge of bidirectional relationship between diabetes and periodontal disease among diabetes patients: A systematic review. Int J Dent Hyg. 2023 Feb;21(1):28-40. doi: 10.1111/idh.12586. Epub 2022 Feb 4.
- 11. Kulkarni, V. K., Dixit, M., Balasubramanian, S. & Jetpurwala, A. 2023. Gingival and periodontal diseases in children. Pediatr Dent, 21, 264-70.
- 10. Jadon, A. S., Kaushik, M. P., Anitha, K., Bhatt, S., Bhadauriya, P. & Sharma, M. 2024. Types of diabetes mellitus, mechanism of insulin resistance and associated complications. Biochemical immunology of diabetes and associated complications. Elsevier. 1-18.
- Isola G, Santonocito S, Lupi SM, Polizzi A, Sclafani R, Patini R, Marchetti E. Periodontal Health and Disease in the Context of Systemic Diseases. Mediators Inflamm. 2023 May 13;2023:9720947. doi: 10.1155/2023/9720947. eCollection 2023.
- 8. Fiorellini, J., Ishikawa, S. & Chai, S. 2024. Clinical features of gingivitis. Newman and Carranza's Clinical Periodontology. 4th South Asia Edition, 12, 158-66.
- Elgasmi FE, Maghous K, Badre B. Gingivitis in children and adolescents: epidemiological overview and associated factors-A narrative review. Front Oral Health. 2025 Oct 10;6:1675033. doi: 10.3389/froh.2025.1675033. eCollection 2025.
- Poppolo Deus F, Ouanounou A. Chlorhexidine in Dentistry: Pharmacology, Uses, and Adverse Effects. Int Dent J. 2022 Jun;72(3):269-277. doi: 10.1016/j.identj.2022.01.005. Epub 2022 Mar 12.
- Chis A, Noubissi PA, Pop OL, Muresan CI, Fokam Tagne MA, Kamgang R, Fodor A, Sitar-Taut AV, Cozma A, Orasan OH, Heghes SC, Vulturar R, Suharoschi R. Bioactive Compounds in Moringa oleifera: Mechanisms of Action, Focus on Their Anti-Inflammatory Properties. Plants (Basel). 2023 Dec 20;13(1):20. doi: 10.3390/plants13010020.
- Brookes ZLS, McCullough M, Kumar P, McGrath C. Mouthwashes: Implications for Practice. Int Dent J. 2023 Nov;73 Suppl 2(Suppl 2):S98-S101. doi: 10.1016/j.identj.2023.08.013. Epub 2023 Oct 19.
- 3. Balagopal, S. & Arjunkumar, R. 2013. Chlorhexidine: the gold standard antiplaque agent. J Pharm Sci Res, 5, 270-5.
- Asokan S, Emmadi P, Chamundeswari R. Effect of oil pulling on plaque induced gingivitis: a randomized, controlled, triple-blind study. Indian J Dent Res. 2009 Jan-Mar;20(1):47-51. doi: 10.4103/0970-9290.49067.
- Abdelkarim, N. & Youssif, E. 2025. Oil Pulling in Dentistry. A Review. J Cont Dent Sci, 2, 1-8.
Полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- Gingivitis reducing mouthwash
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Сроки обмена IPD
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- МКФ
Данные исследования/документы
-
Протокол исследования
Информационный идентификатор: Protocol
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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