Calcium-vitamin D & Periodontal Therapy for Improving Metabolic and Inflammatory Profile Among Pregnant Women
Condition: Periodontitis; Inflammation
MeSH terms: Periodontitis; Inflammation
Study type: Interventional

Summary: 
      The improvement of maternal and child health remains a key issue in global health. Production
      and improved accessibility of healthy and nutrient-rich milk-based products could potentially
      tackle health and nutrition inequalities in low-income countries.

      This study will assess the acceptability of a multi-component intervention, including
      provision of calcium/vitamin-D fortified milk and periodontal therapy (PT), for improving
      maternal periodontal health and metabolic and inflammatory profiles. The IMPROVE trial is a
      feasibility randomised controlled trial (RCT) with parallel qualitative process evaluation.
      The target population is low-income, pregnant, Brazilian women, with periodontitis, who have
      not seen a dentist in the last 6 months. A series of focus group discussions and interviews
      with the target population will be conducted to identify key barriers and enablers to
      adoption and implementation of the intervention in prenatal clinics in Rio de Janeiro/Brazil.
      Participants will be allocated to 4 groups: 1) early PT (during pregnancy) plus fortified
      milk; 2) early PT plus plain milk; 3) delayed PT (after delivery) plus fortified milk; 4)
      delayed PT plus plain milk.

      The final results will contribute to the understanding of the significance of calcium and
      vitamin D for short and long-term health and the occurrence of diseases, as well as to inform
      the current global debate on vitamin-D supplementation and fortification policy.
    


Intervention name(s): Early PT; Delayed PT; Fortified Milk; Plain Milk
Intervention type(s): Other; Other; Dietary Supplement; Dietary Supplement
Intervention description(s): Women will receive conventional non-surgical periodontal therapy (PT), consisting of prophylactic dental polishing to remove the sticky bacterial film that forms on the teeth over time, scaling and root planing, as necessary throughout pregnancy, up to delivery; Women will receive conventional non-surgical PT delayed until after delivery.; participants will be advised to take two servings of a powdered milk-based drink enriched with calcium and vitamin D daily during breakfast and afternoon snack or supper to avoid concomitant intake of the prenatal iron supplements routinely prescribed for consumption with hot main meals (e.g. lunch or dinner). Women will be advised to consume 20 g of commercially available semi-skimmed milk powder (provided by the study) and one sachet with 500 IU of vitamin D3 and 1,2 g of a calcium supplement from milk extract (300 mg of calcium) twice a day.; Women will be advised to consume 20 g of commercially available semi-skimmed milk powder (provided by the study) and one sachet with flour (placebo).
Other intervention name(s): Early non-surgical periodontal therapy; Delayed non-surgical periodontal therapy; non-fortified milk (placebo)
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: 2x2 factorial design
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pregnancy outcome; Feasibility; Milk Fortification; Periodontitis; Pregnant women; Periodontal Therapy