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临床试验/CTRI/2024/02/062581
CTRI/2024/02/062581已完成不适用

Association of Periodontitis, Gestational Diabetes Mellitus and Adverse Pregnancy Outcomes: A Prospective Study

Department of Periodontia and Community Dentistry ZADC1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年2月19日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Gestational Diabetes Mellitus

研究概览

简要总结

This is a Prospective cohort study with aim of studying  association of Periodontal status and Salivary TNF-alpha level with Gestational Diabetes Mellitus and Adverse pregnancy outcomes in pregnant women.

Periodontitis is a global health problem and is strongly associated with systemic diseases. Prevalence of Gestational diabetes  mellitus is also growing in line with the spread of diabetes mellitus. Chronic inflammation have been implicated in the pathogenesis of GDM. Periodontal Disease is associated with increased level of systemic inflammation mediators and can be a potential risk factor for GDM. Both Periodontal Disease and GDM are associated with increased systemic inflammation, pregnant females suffering from both may have increased risk of developing Adverse Pregnancy Outcomes.

 Participant recruitment is going to be done in Department of Obstetrics and Gynaecology,  JNMCH.  100 number of participants in each exposed (periodontitis) and unexposed group (gingivitis and clinically healthy gingiva). Participants during 10th to 14th weeks of Gestation are screened and grouped based on periodontal condition . Around  24th to 28th weeks of Gestation second visit is planned and primary outcome (Gestational Diabetes mellitus) is evaluated. Adverse Pregnancy Outcomes assessment will be done post delivery. Comprehensive oral hygiene instructions will be given to all and oral prophylaxis is administered if deemed necessary. Salivary Samples collection will be done during first and second visit and stored as per standardization later to be assessed for TNF-alpha level estimation.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • Age of 18 years and above.
  • Gestational age of 10-14 weeks.
  • Participants who provided written approval.

排除标准

  • Age less than 18 years.
  • Participants with pregestational diabetes or family History of Diabetes mellitus.
  • Participants with chronic diseases and alcohol/tobacco abuse.
  • participants underwent periodontal or antibiotic therapy within 3 months of recruitment.

结局指标

主要结局

Gestational Diabetes Mellitus

时间窗: Second visit, during 24th-28th weeks of Gestational age

次要结局

  • Adverse Pregnancy Outcomes, like preterm & low birth weight(Third Visit, post delivery)

研究者

发起方
Department of Periodontia and Community Dentistry ZADC
申办方类型
Other [Government Dental College ]
责任方
Principal Investigator
主要研究者

Nancy Budakoti

Dr Ziauddin Ahmed Dental College and Hospital, Aligarh Muslim University

研究点 (1)

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