Investigation of Periodontal Inflammatory Mediators in Permanent Molars Affected by Molar-incisor Hypomineralization
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Concentration of proinflammatory and anti-inflammatory cytokines in gingival crevicular fluid
研究概览
简要总结
The goal of this observational study is to investigate periodontal inflammatory mediators in systemically healthy children aged 8-13 years with and without molar-incisor hypomineralization (MIH) who require initial periodontal treatment due to gingivitis.
The main questions it aims to answer are:
Are the levels of periodontal inflammatory mediators in gingival crevicular fluid different between children with MIH and those without MIH? Is the presence and severity of MIH associated with clinical periodontal parameters and dentin hypersensitivity?
Researchers will compare children with MIH to children without MIH to determine whether MIH is associated with changes in periodontal inflammatory mediator levels and periodontal clinical findings.
详细描述
Participants will:
Provide written informed consent from their parent or legal guardian before enrollment.
Complete a dental and oral hygiene history questionnaire. Undergo a comprehensive oral examination, including assessment of MIH severity using the MIH Treatment Need Index (MIH-TNI), dentin hypersensitivity using the Schiff Cold Air Sensitivity Scale, plaque index, gingival index, bleeding on probing, and periodontal probing depth.
Provide gingival crevicular fluid samples collected using Periopaper® strips for analysis of periodontal inflammatory mediators.
The following clinical indices and assessment criteria will be used during the clinical examination.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy children aged 8-13 years (both sexes).
- •Children who demonstrate adequate cooperation for dental treatment and study procedures (Frankl Behavior Rating Scale score ≥3).
- •Study group: Children with molar-incisor hypomineralization (MIH) affecting at least three permanent first molars and requiring initial periodontal treatment for gingivitis.
- •Control group: Children without molar-incisor hypomineralization who require initial periodontal treatment for gingivitis.
- •Presence of gingivitis requiring initial periodontal therapy.
排除标准
- •Use of antibiotics within the previous 1 month.
- •Radiographic evidence of periodontal destruction.
- •History of periodontal treatment within the previous 3 months.
- •Presence of systemic, chronic, or metabolic diseases.
- •Ongoing active orthodontic treatment.
- •Developmental enamel defects other than molar-incisor hypomineralization.
- •History of premature birth.
研究组 & 干预措施
MIH patients requiring initial periodontal treatment
干预措施: Initial periodontal treatment (Procedure)
Patients without MIH requiring initial periodontal treatment
干预措施: Initial periodontal treatment (Procedure)
结局指标
主要结局
Concentration of proinflammatory and anti-inflammatory cytokines in gingival crevicular fluid
时间窗: Baseline, 1 month after initial periodontal therapy, and 3 months after initial periodontal therapy
Quantitative concentrations (pg/mL) of IL-1α, IL-1β, IL-6, IL-8, TNF-α, IFN-γ and IL-4, IL-10, IL-13, TGF-β1 measured in gingival crevicular fluid using enzyme-linked immunosorbent assay (ELISA).
Concentration of matrix metalloproteinases in gingival crevicular fluid
时间窗: Baseline, 1 month after initial periodontal therapy, and 3 months after initial periodontal therapy
Quantitative concentrations (pg/mL) of MMP-2, MMP-3, MMP-8, MMP-9, MMP-20, and TIMP-1 measured in gingival crevicular fluid using ELISA. Measurements will be obtained at baseline (before initial periodontal therapy) and after completion of initial periodontal therapy.
Total oxidant status and total antioxidant status in gingival crevicular fluid
时间窗: Baseline, 1 month after initial periodontal therapy, and 3 months after initial periodontal therapy
Total Oxidant Status (TOS) and Total Antioxidant Status (TAS) measured by spectrophotometric analysis at baseline (before initial periodontal therapy) and after completion of initial periodontal therapy.
次要结局
未报告次要终点