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临床试验/CTRI/2025/02/080045
CTRI/2025/02/080045尚未招募2/3 期

Comparative Evaluation of Catalase Enzyme Production In Children With and Without Early Childhood Caries- A Randomized Control Trial

Saveetha Dental college and hospitals1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年2月17日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Primary outcome: Catalase enzyme activity in the saliva of children with and without ECC.at baseline and 3 months

研究概览

简要总结

Early Childhood Caries (ECC) is a widespread public health concern, characterised by the rapid progression of dental decay in the primary teeth of young children. Its multifactorial aetiology encompasses dietary habits, oral hygiene practices, the presence of cariogenic microorganisms, and, increasingly, the role of oxidative stress in oral disease development. Oxidative stress occurs when there is an imbalance between reactive oxygen species (ROS) and the body’s ability to neutralise these harmful molecules through antioxidants, which has been identified as a contributing factor in dental caries progression.

Saliva, an essential physiological fluid, contains a complex mix of enzymes, proteins, and antioxidants that contribute to the maintenance of oral health. Among these, catalase (CAT) plays a critical role in mitigating oxidative damage by breaking down hydrogen peroxide—a byproduct of oxidative metabolism—into water and oxygen. Elevated levels of catalase activity have been observed in the presence of inflammatory processes in the oral cavity, and it serves as an early marker of oxidative stress. In children, the antioxidant defence mechanisms present in saliva, including CAT, are essential for protecting against oral disease, particularly in environments prone to oxidative stress, such as carious lesions.

Oxidative stress, primarily initiated by an overproduction of ROS, has been identified as a predisposing factor in the development and progression of dental caries. By impairing the balance between demineralization and remineralization of tooth enamel, oxidative stress can significantly impact the oral environment, leading to caries activity. Saliva’s antioxidant system, including CAT, serves as a first line of defence, reducing the harmful effects of ROS and supporting tissue health.

Recent studies have highlighted the importance of exploring saliva as a diagnostic tool due to its rich composition of enzymes and antioxidants. Catalase, in particular, has garnered attention for its ability to neutralise hydrogen peroxide and protect oral tissues from oxidative damage. Variations in catalase production and activity in saliva can be influenced by several factors, including genetics, age, health status, and environmental exposures.

Despite the growing body of research on oxidative stress and its role in various oral diseases, limited studies have focused on its contribution to ECC, especially in children. Understanding the relationship between catalase activity and ECC could provide valuable insights into the antioxidant defence mechanisms in children and help identify early biomarkers for the disease. This information could be crucial in developing preventive strategies aimed at reducing the burden of ECC through early detection and intervention.

This randomized controlled trial (RCT) aims to compare catalase enzyme production in children with and without ECC. By examining the differences in CAT activity between these two groups, this study seeks to provide a better understanding of the role of oxidative stress in the development of ECC and its potential implications for preventive care.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor 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

  • Children aged 3–6 years diagnosed with early childhood caries (ECC) based on the American Academy of Pediatric Dentistry (AAPD) criteria (ECC group).
  • Caries-free children with no history of dental caries (Non-ECC group).
  • Participants were recruited from paediatric dental clinics who were accompanied by parents or guardians who gave informed consent.

排除标准

  • Children with underlying health conditions or medical issues.
  • Children with special needs or disabilities.
  • Children on medications affecting salivary composition.
  • Children with any oral soft tissue lesions.
  • Children who had received fluoride treatment in the last 2 weeks.

结局指标

主要结局

Primary outcome: Catalase enzyme activity in the saliva of children with and without ECC.at baseline and 3 months

时间窗: Primary outcome: Catalase enzyme activity in the saliva of children with and without ECC.at baseline and 3 months

次要结局

  • DMFT index evaluation for caries experience(Immediate comparative assessment)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Janani

Saveetha University

研究点 (1)

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