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临床试验/NCT00641901
NCT00641901已完成不适用

A Study of Oral Health Care Education and Therapy to Reduce Gingivitis During Pregnancy

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Reduced gingival inflammation

研究概览

简要总结

Compelling evidence suggesting a possible link between maternal pregnancy-related periodontitis (gum disease) and spontaneous pre-term birth (PTB)makes effective management of oral health a relevant and significant obstetrical-dental issue.

The purpose of this pilot study is to determine whether intensive education and counseling can help pregnant women learn to maintain excellent oral health and in doing so reduce the severity of gingivitis and periodontitis during their pregnancy. Failure to effectively remove the plaque biofilm from the surface of teeth every day is the crucial event leading to the development of gingivitis and plaque-induced gingivitis is the most common form of periodontal disease in pregnant women.

We therefore hypothesize that patients can be taught to effectively modulate their own disease through intensive education and meticulous home care coupled with closely monitored behavior modification.

We believe this may be an effective approach toward improving oral health with the potential to reduce adverse pregnancy outcomes.

详细描述

Adverse pregnancy outcomes are significant personal and public health issues in the United States where approximately 12% of all births are pre-term (<37 weeks gestation). Care for these neonates accounts for over 5 million neonatal intensive care hospital stays each year and close to $6 Billion in annual health care costs. Premature delivery and low birth weight (LBW) are leading determinates of neonatal mortality and serious morbidity often leading to neurological and developmental restrictions in early childhood. Concomitant to these data are significant social and psychological consequences related to maternal and family distress and the effects of personal loss.

The role of maternal periodontitis as a potential stressor having detrimental effects on pregnancy outcomes is a relatively new area of investigation. Nevertheless, increasing evidence exists to support an association between maternal periodontal disease, a chronic anaerobic inflammatory condition of the oral cavity, and adverse pregnancy outcomes including pre-term birth (PTB) and fetal growth restriction. This is particularly true with very early-in-gestation delivery.

After adjusting for age, race, smoking and parity, a prospective study of over one-thousand pregnant women conducted at the University of Alabama at Birmingham (UAB) demonstrated that periodontal disease is associated with an increased risk of pre-term birth (PTB) by an odds ratio 4-7, depending on disease severity. These data showed a 55% prevalence of periodontal disease among this cohort; a much higher prevalence than had been reported in national surveys.

The mechanisms responsible for this association remain unclear. However, substantial data suggest that systemic inflammation, as measured by serum C-reactive protein and other inflammatory mediators may well underlie the observed associations.

Investigators hypothesize that links between maternal infections and pre-term bith involve microbes and host response to microbes that enter the uterine cavity during pregnancy. In cases of remote infection, such as periodontitis, this may occur via a blood-bourne route which triggers an alteration in the normal cytokine and hormone regulatory gestation that can result in premature labor, early rupture of membranes and preterm birth.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Confirmed pregnancy between 16 and 24 weeks gestation
  • Minimum of 20 natural teeth
  • Gingival inflammation 50% of teeth

排除标准

  • Multiple gestations
  • Positive history for HIV infection, AIDS, Diabetes Mellitus
  • Rampant untreated caries
  • Concomitant Orthodontic treatment
  • Medical condition that requires antibiotic prophylaxis prior to dental treatment
  • Chronic use of medication that may cause gingival hypertrophy
  • Chronic use of steroids
  • Any obstetrical contraindication

结局指标

主要结局

Reduced gingival inflammation

时间窗: 8 weeks

次要结局

  • Reduced pre-term birth(40 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Reddy, DMD

Dean, School of Dentistry

University of Alabama at Birmingham

研究点 (1)

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