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临床试验/NCT07016659
NCT07016659尚未招募3 期

Assessing Antiplaque And Antigingivitis Efficacy Of Triphala Mouthwash Versus Chlorhexidine Mouthwash Among A Group Of Children: A Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年9月1日最近更新:
干预措施
相关药物

试验速览

阶段
3 期
状态
尚未招募
入组人数
36
试验地点
1
主要终点
The amount of plaque accumulation by using Plaque Index The plaque index will be recorded using the mirror, periodontal probe, and disclosing agent to detect areas of plaque accumulation that will be stained by the disclosing agent at tooth surfaces

研究概览

简要总结

The study aim to to assess the antiplaque and antigingivitis efficacy of Triphala mouthwash versus chlorhexidine mouthwash among children.

Oral health, acknowledged as equally significant to general health, has become an essential component of an individual's entire well-being. Dental caries and periodontal problems are the two predominant oral conditions that repeatedly affect nearly all individuals throughout their entire lives (Sharma et al., 2014).

Numerous bacterial communities can be found in the oral cavity. These bacteria are harmless if proper health is maintained and are a healthy part of the human microbiome; However, disturbances to the local or systemic environment can lead to opportunistic infections such as periodontitis, gingivitis, or cavities .

It has been known that dental plaque plays a critical role in the development and progression of periodontal disease, gingivitis, and dental caries. Plaque control is the first line of defense against periodontal disease and gingival inflammation, and chemical plaque control methods should always be used in conjunction with mechanical methods .

Plaque removal is constantly maintained by mechanical techniques like toothbrushing and flossing, which are essential for controlling and preventing gingivitis, periodontitis, and dental caries. For mechanical plaque control, children need chemotherapeutic agents like therapeutic mouthwash since they lack the motivation or hand-eye coordination to reach the interproximal locations on their own.

Herbal medicine takes a preventative and promotional strategy. It is an integrated approach that treats diseases and promotes health by using a variety of treatments made from plants and their extracts. The use of natural herbs such as Triphala, Tulsi Patra, Jyestiamadh, Neem, Clove Oil, Pudina, Ajwain, and many more, either alone or in combination, has been shown by research to be a safe and effective treatment for a variety of oral health issues, including mouth ulcers, bleeding gums, halitosis, and tooth decay prevention .

Triphala, which exhibits antibacterial, antiseptic, and anti-inflammatory effects, is one of the most popular formulas in traditional Ayurvedic medicine. It is extensively used in dentistry and includes equal amounts of Terminalia Chebula, Terminalia Belerica, and Emblica Officinalis .

Triphala comprises tannins that facilitate the physical removal of microorganisms by aggregating them. This reduces the quantity of bacteria adhering to teeth during the initial phases of plaque development. Triphala mouth rinse exhibits extensive antibacterial activity against both Gram-positive and Gram-negative pathogens. It also demonstrates antioxidant properties that aid in minimizing dental plaque and gingivitis. The tannic acid in Triphala may facilitate plaque reduction by binding to bacterial cell surfaces that denature proteins and eradicate bacterial cells.

详细描述

The oral cavity possesses many kinds of bacterial communities. In a healthy condition, these bacteria are benign and represent a component of the human microbiome; however, changes in local or systemic environments can lead to opportunistic infections such as caries, gingivitis, or periodontitis (Vlam, 2019).

Gingivitis develops after 2 to 3 weeks of uninterrupted plaque accumulation, accompanied by a transition in subgingival bacteria from gram-positive to gram-negative species. Plaque-induced gingivitis, the most common form of periodontal disease, has been demonstrated by epidemiological studies to be frequent among dentate populations of all ages (Murakami et al., 2018; Deus and Ouanounou, 2022). In children aged 6 to 11, gingivitis was present in almost 73% of cases in developed nations. Besides, 50 - 99% of people develop gingivitis throughout adolescence (Pari et al., 2014).

Chlorhexidine (CHX) has established a reputation as the gold standard in chemical plaque reduction; however, long-term usage of CHX may result in a variety of problems, including dry mouth, changed taste perception, metallic taste, and tooth discoloration. Despite its anti-plaque capabilities, 0.12% CHX mouthwash has been associated with increased calculus deposition (Zanatta et al., 2010; Dandekar and Winnier, 2020). Thus, the quest for an ideal mouthwash with the beneficial properties of CHX without its side effects continues.

Triphala is one of the most popular formulations in ancient Ayurvedic medicine because it possesses antibacterial, antiseptic, and anti-inflammatory properties. It contains equal quantities of Terminalia Chebula, Terminalia Belerica, and Emblica Officinalis; it is commonly used in dentistry. Triphala was chemically examined and was discovered to have tannic acid, chebulic acid, and flavonoids as major ingredients (Minervini et al., 2024; Singaraju et al., 2024).

Triphala includes tannins, which assist in physically eliminating microorganisms by aggregating them together. This reduces the quantity of germs that attach to teeth during the initial stages of plaque development. Triphala mouth rinse has wide antibacterial properties against both Gram-positive and Gram-negative pathogens. It also has antioxidant properties that aid in reducing dental plaque and gingivitis (Minervini et al., 2024; Singaraju et al., 2024).

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
9 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients aged 9 to 13 years.
  • Apparently in good general health.
  • Both sexes.
  • Informed consent from their parents.
  • Patients with fair oral hygiene and gingival inflammation.
  • Participants should not have used mouthwashes for the follow-up period.

排除标准

  • Patients with known allergies to any ingredient used in the study.
  • History of immunosuppressive diseases.
  • History of antibiotic or anti-inflammatory therapy in the previous month till the start of the study.
  • Patients with orthodontic appliances.
  • Parents refused to participate or were unable to attend follow-up visits.

研究组 & 干预措施

use 0.12% Chlorhexidine mouthwash to asses its anti-plaque and anti-gingivitis effect

Placebo Comparator

干预措施: 0.12% Chlorhexidine Mouthwash ( Hexitol ) (Drug)

use Triphala mouthwash to asses its anti-plaque and anti-gingivitis effect

Experimental

干预措施: Triphila mouthwash (Drug)

结局指标

主要结局

The amount of plaque accumulation by using Plaque Index The plaque index will be recorded using the mirror, periodontal probe, and disclosing agent to detect areas of plaque accumulation that will be stained by the disclosing agent at tooth surfaces

时间窗: From intervention till 3 weeks

Criteria of plaque index: 0 = No plaque. 1. = Film of plaque adhering to the free gingival margin and adjacent area of the tooth. 2. = Moderate accumulation of plaque within the gingival pocket. 3. = An Abundance amount of plaque within the gingival pocket. To obtain the plaque index score for each tooth: The sum of the four tooth surface scores will be divided by four.

次要结局

  • Gingival health by using Gingival Index The gingival index will be recorded using a mirror and periodontal probe to assess the gingival status in four areas for each tooth including buccal, lingual, mesial, and distal.(From intervention till 3 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nourhan Emad Abdelrazik Ahmed

Pediatric Dentist

Cairo University

研究点 (1)

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