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

Abstract

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.

Keywords: calcium; exploratory efficacy; feasibility trial; periodontitis; pregnant women; vitamin D.

Figure 1

Flowchart of enrolment, allocation, and follow-up of the pregnant women from a low socioeconomic area in Rio de Janeiro. PT: Periodontal treatment. ^* Not started periodontal treatment (n = 1) or milk consumption (n = 1) or both (n = 1). ^** Not started milk consumption (n = 1).

Figure 2

Difference in the periodontal treatment and milk fortification effects of interventions (delta) in calcium and bleeding on probing. Late PT: Periodontal treatment postpartum. Early PT: Periodontal treatment during pregnancy. Fortified: milk with the fortification of calcium and vitamin D. Placebo: milk without fortification. Delta of calcium (mg/dL) and bleeding on probing (%): levels in T2–levels in T0 (baseline).

Figure 3

Difference in the effect of periodontal treatment intervention on delta insulin levels and delta bleeding on probing. Late PT: Periodontal treatment postpartum. Early PT: Periodontal treatment during pregnancy. Delta of insulin and bleeding on probing: levels in T2–levels in T0 (baseline).