跳至主要内容
临床试验/CTRI/2024/12/077688
CTRI/2024/12/077688已完成Phase 3 4

A Comparative Study on the Role of Smart Phone Application in Improving Oral Health with the Antimicrobial Efficacy of Paediatric Dentifrices along with Salivary alpha-amylase in Early Childhood Caries

Arunima Sarkar1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2024年12月14日最近更新:
适应症

试验速览

阶段
Phase 3 4
状态
已完成
发起方
入组人数
56
试验地点
1
主要终点
The outcome expected out of this research is the comparison of the efficacy of High fluoridated (1000 ppm), commonly used paediatric dentifrices along with the traditionally followed Low Fluoridated (458 ppm), Non- Fluoridated and Herbal Formulations available in the market against the most common causative microorganism found in Early Childhood Caries

研究概览

简要总结

The human oral cavity is one of the most densely populated sites in the body. It contains a diversity of microbial populations that give rise to distinct bacterial communities, including dental caries and dental plaque.1 Dental caries stands as the most widespread infectious microbial ailment on a global scale.2 It is often caused by acidic demineralization of tooth enamel and dentin due to biofilm produced by microorganisms associated with plaque. Dental plaque forms when bacteria colonise the acquired enamel pellicle.1 1 gram of plaque contains 1011 bacteria. While dental plaque occurs naturally, it is also linked to two of the most common diseases in industrialized societies: caries and periodontal diseases.2

Early Childhood Caries (ECC) is recognized as the most severe and damaging manifestation of dental caries, impacting children under the age of 6. The leading organism of the microbiota of oral cavity is Streptococcus mutans (SM) and its elevated level in the saliva has been the primary factor causing Early Childhood Caries.3 By decomposing sugars present on the surface of the tooth, this facultative anaerobe generates an environment that is acidic, leading to the eventual demineralization of calcium on the surface of the tooth. Lactobacillus acidophilus is the second most common microorganism found in oral microflora.While not serving as the initiator of caries, it plays a crucial role in the progression of dental decay. The primary characteristic of the Lactobacillus genera is the production of acids from sugars that are fermentable, which contribute to the process of tooth decay.4

Also, Saliva plays an important role as a non-invasive local tool for diagnosis of systemic diseases, as it consists of glycoprotein, electrolytes, immunoglobulins and variety of enzymes. The omnipresent enzyme in saliva is salivary alpha-amylase, which hydrolyses  insoluble form of starch into the form which is soluble and helps in the digestion of carbohydrates. The enzyme’s notable characteristic is its strong affinity for binding to both tooth structure and streptococci present in oral cavity and therefore increased salivary alpha-amylase levels indicate the presence of dental caries in the oral cavity. 5

Mechanical oral hygiene aids are the most effective method for the prevention of dental caries and dental Plaque including toothbrushes and toothpaste.6 The dentifrices are available under various categories such as fluoridated and non-fluoridated, depending on the amount of fluoride content in the toothpaste. Fluoride possesses antimicrobial properties that hinder the growth of microorganisms, slowing down plaque development by reducing their ability to produce acids.7 Fluoridated toothpastes are further classified as Low fluoridated (<500 ppm) and High fluoridated(>500 ppm) but have various controversial aspects to it. High fluoridated toothpaste aids in preventing tooth decay by reinforcing the enamel and enhancing its resistance to acid attacks from bacteria as there are reports stating concerns about the acute fluoride toxicity caused by ingestion of fluoridated toothpastes.8 In the realm of dentistry, traditionally low or non-fluoridated toothpastes were popularised because of the propensity for swallowing and the risk of fluorosis.8 With the growing popularity of Herbal toothpaste nowadays, we are compelled to research and determine the efficacy of these toothpaste as Herbal extracts contain phytochemicals that can offer pathways preventing caries of dental origin.7Researchers have undertaken various studies to compare the efficacy of different dentifrices. There have been studies comparing fluoridated dentifrices with other Non -fluoridated as well as Herbal dentifrices. As of today, there is no documented research conducted in India for the use of highly fluoridated dentifrices in children with Early childhood caries.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
3.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • 1.Children between 3-6 years of age.
  • 2.Children having Early Childhood Caries.
  • 3.Children with a DMFT score of 4 or more 4.Children with cooperative behaviour rating 3 & 4 in the Frankel behaviour rating scale.
  • 5.Children who will be willing to show participation in this study.
  • 6.Children whose parents will give informed consent.

排除标准

  • 1.Children with any underlying systemic condition.
  • 2.Children who have received systemic antibiotics recently.
  • 3.Children who are categorised as specially abled child.
  • 4.Children with a recent history of professionally applied topical fluoride.
  • 6.Children with definitely negative Frankl’s behaviour rating.
  • 7.Children undergoing orthodontic procedures or those with an intraoral prosthesis.

结局指标

主要结局

The outcome expected out of this research is the comparison of the efficacy of High fluoridated (1000 ppm), commonly used paediatric dentifrices along with the traditionally followed Low Fluoridated (458 ppm), Non- Fluoridated and Herbal Formulations available in the market against the most common causative microorganism found in Early Childhood Caries

时间窗: 2 WEEKS

次要结局

未报告次要终点

研究者

发起方
Arunima Sarkar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Arunima Sarkar

Sardar Patel Post Graduate Institute of Dental and Medical Sciences Uttar Pradesh

研究点 (1)

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