Assessment of MCM2–7 and Pro-inflammatory Cytokine Expression in the Host Immune Response to Streptococcus mutans in Early Childhood Caries: An In Vivo Study
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To demonstrate the role of immunity in early childhood caries by comparing the expression levels of MCM2–7 and pro-inflammatory cytokines (tumor necrosis factor alpha, interleukin six, and interleukin one beta) in serum samples of children with ECC with swelling, ECC without swelling, and healthy control.
研究概览
简要总结
This study aims to assess the expression of Minichromosome Maintenance Protein 2,7 and pro inflammatory cytokines (TNF alpha, IL 6, IL 1beta) in children aged 3-5 years. The study will include three groups.
Group1 children with ECC with clinical swelling
Group2 children with ECC without swelling
Group3 children with dental caries without pulp tissue involvement
The expression levels of the selected markers will be evaluated to understand the host immune response and molecular changes associated with Streptococcus mutans-induced ECC.
Study Hypothesis
The expression levels of Minichromosome Maintenance Protein 2,7 and pro-inflammatory cytokines (TNF alpha, IL 6, IL 1beta) will be significantly higher in children with ECC, particularly those with clinical swelling, compared to children with caries without pulp involvement.
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 5.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children aged 3–5 years.
- •2.Children who are systemically healthy.
- •3.Children classified into one of the following groups: Group 1: Children with Early Childhood Caries (ECC) presenting with clinical swelling or signs of dental abscess requiring pulpectomy.
- •Group 2: Children with ECC without clinical swelling, requiring pulpectomy.
- •Group 3: ECC with Dental Caries and No Pulpal Involvement 4.Parents or guardians willing to provide written informed consent.
排除标准
- •1.Children with any systemic diseases or immunocompromised status.
- •2.Children who have received antibiotics or anti-inflammatory medication within the past 2 weeks.
- •3.Children with chronic medical conditions (e.g., asthma, diabetes, congenital heart disease).
- •5.Children whose parents/guardians refuse consent.
结局指标
主要结局
To demonstrate the role of immunity in early childhood caries by comparing the expression levels of MCM2–7 and pro-inflammatory cytokines (tumor necrosis factor alpha, interleukin six, and interleukin one beta) in serum samples of children with ECC with swelling, ECC without swelling, and healthy control.
时间窗: Baseline
次要结局
- To evaluate the correlation between the expression levels of MCM2–7 and pro-inflammatory cytokines with the clinical severity of Early Childhood Caries and the presence of swelling.(Single Time-point)
研究者
Somya Seth
Saveetha Dental College and Hospitals