Effect of Non-surgical Periodontal Therapy on Risk of Adverse Pregnancy Outcomes: A Randomized Controlled Trial in Uttarakhand Population.

Background: Chronic disease like periodontitis in the expectant mother are believed to have an association with the occurrence of adverse pregnancy outcomes (APOs) like low birth weight (LBW), preterm birth (PTB), preterm low birth weight (PLBW), pre-eclampsia and stillbirth. The present study aimed to investigate the association between periodontal disease and APOs in north Indian population

Null hypothesis: There is no association between the periodontal health status and adverse pregnancy outcome.

Material and Methods:  Participants who fulfilled the inclusion criteria will be randomly divided into three study groups: (i) Control group: No non-surgical periodontal therapy during pregnancy, only oral hygiene instructions. (ii) Test group 1: pregnant women will receive non-surgical periodontal therapy at 16-20 weeks of gestational age and (iii) Test group 2: Pregnant women will receive non-surgical periodontal therapy once at 16-20 weeks of gestation followed by a repeat of non-surgical therapy at 25-28 weeks of gestation. The obstetric parameters will be recorded after delivery and will be expressed in terms of frequency and percentage. The following periodontal parameters will be measured: Plaque Index, Gingival Index, bleeding on probing, pocket probing depth, clinical attachment levels, teeth present and periodontal case definition. These will be measured at 16-20 weeks of gestation (time-point t1), 21-24 weeks of gestation (time-point t2) and 29-32 weeks of gestation (time-point t3). Data analysis will be performed using ANOVA with Bonferroni correction, paired t-test between groups and a p-value of ≤0.05 will be considered statistically significant. Pearson’s Chi Square test will be performed to determine measure of association between APOs and periodontal health/disease and the Cramér’s V Test evaluated the strength of this association.