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临床试验/NCT03577314
NCT03577314Unknown不适用

Dental Health in Recurrent Miscarriage

Recep Tayyip Erdogan University Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年4月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
recurrent miscarriage

研究概览

简要总结

Oral infections can trigger the production of pro-inflammatory mediators that may be risk factors for miscarriage. The investigators investigated whether oral health care patterns that may promote or alleviate oral inflammation were associated with the history of miscarriage in Turkish women.

详细描述

Power analysis was performed with the G-Power software package to determine sample size.

To cover possible data loss, 10% of a group were added to each group. Medical and dental examination will be performed both of control and experimental groups. In dental examination decayed, missing, or filled teeth (DMFT) index will be used according to World Health Organization (WHO 1997) criteria. All teeth were visually using the International Caries Detection and Assessment System (ICDAS-II).

To analyze the correlation between oral health status and miscarriage linear regression test and for comparison of both the groups (case and control), two sample t test and chi square test were used.

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
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • history of at least two unexplained recurrent miscarriage below 20th week of pregnancy
  • systemically healthy females with at least two normal births
  • no poor obstetric history such as preeclampsia and premature birth

排除标准

  • history of thyroid disease, hyperprolactinemia, antiphospholipid syndrome, systemic lupus erythematosus, autoimmune diseases, thrombophilia, diabetes mellitus, uterine/cervical abnormalities, polycystic ovary syndrome, active liver disease, cardiovascular disease, premature ovarian failure, acute or chronic upper respiratory tract diseases, IVF pregnancy, multiple pregnancy, preeclampsia, arterial or venous embolism, infection,
  • habit of smoking, alcohol, drug or caffeine,
  • abnormal embryo karyotype,
  • infection with hepatitis B or C, and HIV,
  • chromosomal abnormalities,
  • dental fluorosis,
  • fluoride supplements,
  • orthodontic appliances,
  • body mass index ≥ 30 kg / m2
  • age of the partner is found to be over 40

结局指标

主要结局

recurrent miscarriage

时间窗: below 20th week of pregnancy

If abortion material is obtainable, it will be genetically evaluated for chromosomal abnormalities. At least 8 weeks after termination of pregnancy, karyotype analysis of both couples and thrombophilia panel ( Factor V Leiden, prothrombin gene mutation G20210A, protein S/Protein C/antithrombin deficiency and MTHFR mutations) in the study group will be requested.

次要结局

  • Bleeding Examination(1 Day)
  • Dental Examination(1 Day)
  • Periodontal Examination(1 Day)
  • Clinical attachment level(1 Day)
  • Plaque Examination(1 Day)
  • Gingival Examination(1 Day)

研究者

发起方
Recep Tayyip Erdogan University Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gul Yildiz Telatar

Principal Investigator

Recep Tayyip Erdogan University Training and Research Hospital

研究点 (2)

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