Effect of Early Periodontal Therapy on Pregnancy Outcomes- A Randomized Control Trial.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- The following outcome would be measured in both the groups:
研究概览
简要总结
Periodontal diseases (PD) are the most common chronic destructive inflammatory condition of supporting structure of teeth initiated by oral microflora located in biofilms, plaque and calculus1. Studies have shown access of periodontal pathogens to fetoplacental unit through transient bacteraemia or by causing immunological injury through metastatic inflammation or as a lipopolysaccharides reservoir.2
Research has advocated periodontitis as an independent risk factor leading to various adverse pregnancy outcomes (APOs) like IUGR, preterm labour and low-birth-weight(LBW) babies.3,4,5Recent systematic and Cochrane review confirmed6 this with low level of evidence due to variation in time and regimen of periodontal therapy and associated confounders demanding a well-designed randomized control trial.
With very high PD prevalence and NHM statistics showing gruesome maternal and child health scenario; maintaining good periodontal health can be low-hanging fruit in reducing APOs. Already developed countries like Australia, USA, Canada, Europe have included oral health care in ANCs (consensus-based guidelines).
This study aims to draft and implement the effect of specifically designed Comprehensive periodontal health care (CPHC) including early structured periodontal therapy (>10 weeks of gestation) and novel oral health maintenance program. Sustainability of this novel oral health maintenance would be done through app-based nudging, using focused group discussions and group mentoring in the intervention arm. Finally, a log frame analysis would be used for improving the planning, implementing, managing, monitoring and evaluating CPHC.
This study may open the way for including CPHC as an integral part of the ANC regimen during pregnancy to improve pregnancy outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients with confirmed pregnancy through UPT or through USG.
- •All pregnant female in age range of 18 to 35 years with a BMI of 18.5 to 24.9 with at least 20 teeth as a part of dentition would be included in the study.
排除标准
- •History of Frequent diagnosed UTI in preconception period (>3 episodes/year).
- •Diagnosed preconception chronic disease conditions like uncontrolled Diabetes, Hypertension, Thyroid Diseases, AIDS, and Chronic Liver and Renal diseases.
- •History of unexplained Preterm Labour, Preeclampsia, or stillbirth.
- •History of Diagnosed Autoimmune diseases (SLE, Rheumatoid Arthritis, Sjogren Syndrome, Ulcerative Colitis, Antiphospholipid Syndrome.) e.
- •Previous surgeries on the cervix.
- •Multifetal Gestation.
- •Contraindication to periodontal probing such as Congestive cardiac disease.
- •Medications that result in gingival overgrowth such as phenytoin, cyclosporin, and calcium channel blockers.
结局指标
主要结局
The following outcome would be measured in both the groups:
时间窗: Every 1-2 Months coinciding with ANC
1.Proportion of preterm births.
时间窗: Every 1-2 Months coinciding with ANC
次要结局
- The following outcomes would be measured in both the groups:(1. Mean birth weight of neonates.)
研究者
DrKirti Chaudhry
AIIMS Jodhpur