跳至主要内容
临床试验/NCT07787676
NCT07787676尚未招募不适用

Periodontal Status and Thyroid Markers in Pregnancy :A Cross- Sectional Study

Postgraduate Institute of Dental Sciences Rohtak0 个研究点目标入组 100 人开始时间: 2026年9月3日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Thyroid Stimulating hormone

研究概览

简要总结

This cross-sectional study aims to evaluate the association between periodontal status and serum thyroid markers among 100 systemically healthy pregnant women aged 18-45 years in the second trimester (13-27 weeks). Pregnancy is characterized by profound hormonal and immunological changes that influence both periodontal health and thyroid function. While periodontal inflammation has been associated with thyroid dysfunction in the general population, no study has explored this relationship during pregnancy. Participants will be recruited from the Department of Gynaecology, PGIMS, Rohtak, and undergo comprehensive periodontal examination, including periodontal inflamed surface area (PISA), probing pocket depth (PPD), clinical attachment loss (CAL), bleeding on probing (BOP), and plaque index (PI). Blood samples will be collected to assess thyroid stimulating hormone (TSH), triiodothyronine (T3), thyroxine (T4), anti-thyroid peroxidase (Anti-TPO) antibodies, and high-sensitivity C-reactive protein (hsCRP). The primary objective is to determine the association between PISA and serum TSH levels, while secondary objectives include evaluating the relationship of periodontal parameters with T3, T4, Anti-TPO, hsCRP, and the distribution of thyroid profiles (euthyroid, hypothyroid, and hyperthyroid) according to periodontal status. Data will be analyzed using appropriate descriptive statistics, Pearson/Spearman correlation, and multiple linear regression after testing for normality. By investigating the interplay between periodontal inflammation and thyroid function during pregnancy, this study seeks to generate novel evidence that may support integrated periodontal and antenatal care strategies, ultimately contributing to improved maternal and fetal health outcomes.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women aged 18-45 years
  • Singleton pregnancy
  • Gestational age between 13 and 27 weeks (second trimester)
  • Presence of ≥20 natural teeth (excluding third molars)
  • Willingness to participate in the study and provide written informed consent
  • Attendance at the antenatal clinic during the study period
  • Ability to undergo full-mouth periodontal examination

排除标准

  • History of previously diagnosed thyroid disorders (diagnosed prior to pregnancy or currently)
  • Current use of thyroid-related medication
  • Presence of systemic diseases known to affect periodontal status or inflammatory response (e.g., diabetes mellitus, gestational diabetes mellitus, autoimmune diseases, cardiovascular disorders)
  • Use of antibiotics, anti-inflammatory drugs, corticosteroids, or immunosuppressive agents within the previous 3 months
  • Current or past tobacco use in any form (smoking or smokeless)
  • Alcohol consumption during pregnancy
  • Multiple gestations (e.g., twin or higher-order pregnancy)
  • History of periodontal therapy or professional dental cleaning within the last 6 months
  • Presence of acute infections or inflammatory conditions at the time of examination
  • Pregnancy-related complications such as gestational diabetes mellitus, preeclampsia, or threatened abortion
  • Inability or unwillingness to comply with study procedures
  • Presence of acute oral infections or inflammatory conditions at the time of examination (periapical abscess, acute pericoronitis)

结局指标

主要结局

Thyroid Stimulating hormone

时间窗: baseline

evaluation of thyroid stimulating hormone (TSH) and its corelation with clinical periodontal parameters : bleeding on probing (BOP), probing pocket depth (PPD) and clinical attachment loss (CAL), plaque index (PI) and periodontal inflamed surface area (PISA) among pregnant women in second trimester.

次要结局

  • Thyroxine (T4)(baseline)
  • Triiodothyronine (T3)(baseline)
  • Anti-Thyroid Peroxidase Antibody [Anti- TPO](baseline)
  • High Sensitivity C-Reactive Protein (hsCRP)(baseline)

研究者

申办方类型
Other
责任方
Sponsor

相似试验