Effect of non-surgical periodontal intervention and nutritional supplementation on incidence of adverse pregnancy outcomes, colonization of fetoplacental unit by oral bacteria, levels of pro-inflammatory biomarkers and periodontal health: A Randomized Controlled Trial

Recent systematic reviews have suggested that individuals with chronic periodontitis should be counselled to include omega-3 fatty acids in their diet in addition to receiving standard periodontal therapy. Although research has shown that use of omega-3 fatty acid as an adjunct to NSPT is effective in improving periodontal outcomes, there is lack of evidence about the same among pregnant women, who are at high risk of suffering from adverse effects of poor periodontal health. Objectives: To assess and compare the additional benefit of non-surgical periodontal therapy (NSPT) versus omega-3-fatty acids nutritional therapy (NT) alone on the incidence of preterm births (less than 37 weeks of gestation) and low-birthweight (less than 2.5 Kgs) as well as the change in oral & fetoplacental microbiome, pro-inflammatory biomarkers in blood/ saliva and the periodontal health status. Methodology: Pregnant women fulfilling the eligibility criteria will be enrolled in this randomized controlled clinical trial. The study participants will be randomly allocated to one of the four intervention groups. Group 1 participants will receive Oral Hygiene Instructions (OHI) + NSPT, Group 2 subjects will receive OHI + NSPT + nutritional supplementation with 650g omega-3 fatty acids capsules, Group 3 will receive OHI + nutritional supplementation with 650g omega-3 fatty acids capsules while Group 4 participants will receive OHI alone. Periodontal health will be assessed using OHI-S, GR, PD and BOP dental indices, pro-inflammatory biomarkers in the saliva and blood as well as the microbiome assessment of saliva, placenta and dental plaque samples. The outcome parameters will be assessed at baseline, at 28-32 weeks of gestation and once at the first visit of the participant post-delivery. Level of significance will be set at a p-value less than 0.05. Expected Outcomes: The combined effect of NSPT and nutritional supplements using omega-3 fatty acids is expected to be an effective strategy in significantly reducing the incidence of preterm births and low birth weight.