School of Public Health, Fudan University, No, 138 Yixueyuan Road, Shanghai, China.
BMC Pregnancy Childbirth. 2013 Dec 9;13:228. doi: 10.1186/1471-2393-13-228.
Evidence has suggested that periodontal disease is associated with an increased risk of various adverse pregnancy and birth outcomes. However, several large clinical randomized controlled trials failed to demonstrate periodontal therapy during pregnancy reduced the incidence of adverse pregnancy and birth outcomes. It has been suggested that the pre-conception period may be an optimal period for periodontal disease treatment rather than during pregnancy. To date, no randomized controlled trial (RCT) has examined if treating periodontal disease before pregnancy reduces adverse birth outcomes. This study aims to examine if the pre-conception treatment of periodontal disease will lead to improved periodontal status during late pregnancy and subsequent birth outcomes.
METHODS/DESIGN: A sample of 470 (235 in each arm of the study) pre-conception women who plan to conceive within one year and with periodontal disease will be recruited for the study. All participants will be randomly allocated to the intervention or control group. The intervention group will receive free therapy including dental scaling and root planning (the standard therapy), supragingival prophylaxis, and oral hygiene education. The control group will only receive supragingival prophylaxis and oral hygiene education. Women will be followed throughout their pregnancy and then to childbirth. The main outcomes include periodontal disease status in late pregnancy and birth outcomes measured such as mean birth weight (grams), and mean gestational age (weeks). Periodontal disease will be diagnosed through a dental examination by measuring probing depth, clinical attachment loss and percentage of bleeding on probing (BOP) between gestational age of 32 and 36 weeks. Local and systemic inflammatory mediators are also included as main outcomes.
This will be the first RCT to test whether treating periodontal disease among pre-conception women reduces periodontal disease during pregnancy and prevents adverse birth outcomes. If the effect of pre-pregnancy periodontal treatment is confirmed, this intervention could be recommended for application in low- or middle-income countries to improve both oral health and maternal and child health.
This trial is registered with Chinese Clinical Trial Registry (ChiCTR): ChiCTR-TRC-12001913.
有证据表明，牙周病与各种不良妊娠和分娩结局的风险增加有关。然而，几项大型临床随机对照试验未能表明怀孕期间进行牙周治疗可降低不良妊娠和分娩结局的发生率。有人提出，受孕前阶段可能是治疗牙周病的最佳时期，而不是在怀孕期间。迄今为止，尚无随机对照试验（RCT）研究表明，在受孕前治疗牙周病是否可减少不良分娩结局。本研究旨在研究受孕前治疗牙周病是否会改善妊娠晚期的牙周状况和随后的分娩结局。
方法/设计：将招募 470 名（研究组各 235 名）计划在一年内怀孕且患有牙周病的受孕前妇女参加这项研究。所有参与者将被随机分配到干预组或对照组。干预组将接受免费治疗，包括洁牙和根面平整（标准治疗）、龈上预防、口腔卫生教育。对照组仅接受龈上预防和口腔卫生教育。将对妇女进行整个妊娠期间的随访，直至分娩。主要结局包括妊娠晚期的牙周病状况和出生结局，如平均出生体重（克）和平均胎龄（周）。妊娠 32 至 36 周时，通过牙科检查测量探诊深度、临床附着丧失和探诊出血百分比（BOP）来诊断牙周病。局部和全身炎症介质也作为主要结局。
这将是第一项 RCT，旨在测试在受孕前妇女中治疗牙周病是否可降低妊娠期间的牙周病并预防不良分娩结局。如果孕前牙周治疗的效果得到证实，这种干预措施可能会被推荐在中低收入国家应用，以改善口腔健康和母婴健康。
本试验在中国临床试验注册中心注册（ChiCTR）：ChiCTR-TRC-12001913。
