Association between Pre-Pregnancy BMI and Inflammatory Profile Trajectories during Pregnancy and Postpartum in Brazilian Women with Periodontitis: The IMPROVE Trial.

This study aimed to explore the association between pre-pregnancy BMI and longitudinal changes in inflammatory markers from the second trimester of pregnancy to 6-8 weeks postpartum in women with periodontitis. This is a secondary exploratory analysis of 68 women who took part in a feasibility clinical trial in Rio de Janeiro, Brazil. Inflammatory markers included C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-10 (IL-10), and matrix metalloproteinase-9 (MMP-9) blood concentrations at 11-22 (T0) and 30-36 gestational weeks (T1), and 6-8 weeks postpartum (T3). Longitudinal generalised linear mixed-effects models were used to identify possible associations between pre-pregnancy BMI and changes in concentrations of inflammatory markers. Pre-pregnancy excess weight (ß = 4.39; 95% CI, 2.12-6.65) was significantly associated with increased CRP levels from pregnancy to postpartum. There were no significant associations between pre-pregnancy BMI and longitudinal changes in IL-6, IL-10 and MMP-9. Our findings provide evidence that a higher pre-pregnancy BMI may lead to increases in CRP levels during pregnancy in women with periodontitis, irrespective of the severity of clinical periodontal parameters. Further studies need to investigate if predictors of changes in inflammatory markers can be used as prognostic factors for gestational outcomes.

Exploratory Efficacy of Calcium-Vitamin D Milk Fortification and Periodontal Therapy on Maternal Oral Health and Metabolic and Inflammatory Profile.

In this 2 × 2 factorial, outcome-assessor blinded, feasibility randomised trial we explored the effect of a non-pharmaceutical multi-component intervention on periodontal health and metabolic and inflammatory profiles among pregnant women with periodontitis receiving prenatal care in a Brazilian public health centre. 69 pregnant women (gestational age ≤20 weeks, T0) were randomly allocated into four groups: (1) fortified sachet (vitamin D and calcium) and powdered milk plus periodontal therapy during pregnancy (early PT) (n = 17); (2) placebo sachet and powdered milk plus early PT (n = 15); (3) fortified sachet and powdered milk plus late PT (after delivery) (n = 19); (4) placebo sachet and powdered milk plus late PT (n = 18). Third trimester (T1) and 6-8 weeks postpartum (T2) exploratory outcomes included periodontal health (% sites with bleeding on probing (BOP)), glucose, insulin, C-Reactive Protein, serum calcium and vitamin D. The mean BOP was significantly reduced in the early PT groups, while BOP worsened in the late PT groups. No significant effect of fortification on BOP was observed. Changes in glucose levels and variation on birthweight did not differ among groups This feasibility trial provides preliminary evidence for estimating the minimum clinically important differences for selected maternal outcomes. A large-scale trial to evaluate the interventions' clinical benefits and cost-effectiveness is warranted.

Vitamin D and Calcium Milk Fortification in Pregnant Women with Periodontitis: A Feasibility Trial.

This study aims to assess the acceptability, adherence, and retention of a feasibility trial on milk fortification with calcium and vitamin D (Ca+VitD) and periodontal therapy (PT) among low income Brazilian pregnant women with periodontitis (IMPROVE trial). This 2 × 2 factorial feasibility trial used a mixed-methods evaluation. In total, 69 pregnant women were randomly allocated to four groups: 1. fortified sachet with Ca+VitD and milk plus early PT (throughout gestation); 2. placebo and milk plus early PT; 3. fortified sachet with Ca+VitD and milk plus late PT after childbirth; 4. placebo and milk plus late PT. Data were collected via questionnaires, field notes, participant flow logs, treatment diary, and focal group discussions. Quantitative and qualitative data were analysed using appropriate descriptive statistics and content analysis, respectively. Eligibility rate (12%) was below the target of 15%, but participation (76.1%) and recruitment rate (2 women/week) exceeded the targets. Retention rate (78.6%) was slightly below the target (80%). Adherence to the PT was significantly higher in the early treatment groups (98.8%) compared to the late treatment groups (29%). All women accepted the random allocation, and baseline groups were balanced. There was no report of adverse events. This multi-component intervention is acceptable, well-tolerated, and feasible among low-risk pregnant women in Brazil.