Cocate Paula Guedes, Kac Gilberto, Heitmann Berit L, Nadanovsky Paulo, da Veiga Soares Carvalho Maria Cláudia, Benaim Camila, Schlüssel Michael Maia, de Castro Maria Beatriz Trindade, Alves-Santos Nadya Helena, Baptista Amanda Farnum, Holick Michael F, Mokhtar Rana R, Bomfim Alessandra Raymundo, Adegboye Amanda Rodrigues Amorim
1Department of Bioscience and Physical Activity, School of Physical Education and Sports, Rio de Janeiro Federal University, Rio de Janeiro, Brazil.
2Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.
Pilot Feasibility Stud. 2019 Mar 5;5:38. doi: 10.1186/s40814-019-0417-6. eCollection 2019.
Periodontitis is a common oral inflammation, which is a risk factor for adverse pregnancy outcomes. Intakes of vitamin D and calcium are inversely associated with occurrence and progression of periodontitis. This study aims to assess the feasibility of a multi-component intervention, including provision of milk powder supplemented with calcium and vitamin D and periodontal therapy (PT), for improving maternal periodontal health and metabolic and inflammatory profiles of low-income Brazilian pregnant women with periodontitis.
The IMPROVE trial is a feasibility randomised controlled trial (RCT) with a 2 × 2 factorial design with a parallel process evaluation. Pregnant women with periodontitis, aged 18-40 years and with < 20 gestational weeks ( = 120) were recruited and randomly allocated into four groups: (1) fortified sachet (vitamin D and calcium) and powdered milk plus PT during pregnancy, (2) placebo sachet and powdered milk plus PT during pregnancy, (3) fortified sachet (vitamin D and calcium) and powdered milk plus PT after delivery and (4) placebo sachet and powdered milk plus PT after delivery. Dentists and participants are blinded to fortification. Acceptability of study design, recruitment strategy, random allocation, data collection procedures, recruitment rate, adherence and attrition rate will be evaluated. Data on serum levels of vitamin D, calcium and inflammatory biomarkers; clinical periodontal measurements; anthropometric measurements; and socio-demographic questionnaires are collected at baseline, third trimester and 6-8 weeks postpartum. Qualitative data are collected using focus group, for analysis of favourable factors and barriers related to study adherence.
Oral health and mineral/vitamin supplementation are much overlooked in the public prenatal assistance in Brazil and of scarcity of clinical trials addressing these issues in low and middle-income countries,. To fill this gap the present study was designed to assess the feasibility of a RCT on acceptability of a multi-component intervention combining conventional periodontal treatment and consumption of milk fortified with calcium-vitamin D for improving periodontal conditions and maternal metabolic and inflammation status, among Brazilian low-income pregnant women with periodontitis. Thus, we hope that this relatively low-cost and safe multicomponent intervention can help reduce inflammation, improve maternal periodontal health and metabolic profile and consequently prevent negative gestational outcomes.
NCT, NCT03148483. Registered on May 11, 2017.
牙周炎是一种常见的口腔炎症，是不良妊娠结局的危险因素。维生素D和钙的摄入量与牙周炎的发生和进展呈负相关。本研究旨在评估一种多成分干预措施的可行性，该措施包括提供补充钙和维生素D的奶粉以及牙周治疗（PT），以改善患有牙周炎的巴西低收入孕妇的牙周健康以及代谢和炎症状况。
IMPROVE试验是一项可行性随机对照试验（RCT），采用2×2析因设计和平行过程评估。招募年龄在18 - 40岁、孕周<20周（n = 120）的牙周炎孕妇，并随机分为四组：（1）孕期强化包（维生素D和钙）及奶粉加PT；（2）孕期安慰剂包及奶粉加PT；（3）产后强化包（维生素D和钙）及奶粉加PT；（4）产后安慰剂包及奶粉加PT。牙医和参与者对强化情况不知情。将评估研究设计、招募策略、随机分配、数据收集程序、招募率、依从性和损耗率的可接受性。在基线、孕晚期和产后6 - 8周收集血清维生素D、钙和炎症生物标志物水平的数据；临床牙周测量数据；人体测量数据；以及社会人口学调查问卷。使用焦点小组收集定性数据，以分析与研究依从性相关的有利因素和障碍。
在巴西的公共产前护理中，口腔健康和矿物质/维生素补充剂被严重忽视，而且在低收入和中等收入国家，针对这些问题的临床试验也很匮乏。为了填补这一空白，本研究旨在评估一项RCT的可行性，该试验针对患有牙周炎的巴西低收入孕妇，采用常规牙周治疗和食用钙 - 维生素D强化牛奶相结合的多成分干预措施，以改善牙周状况以及孕产妇的代谢和炎症状态。因此，我们希望这种相对低成本且安全的多成分干预措施能够帮助减轻炎症，改善孕产妇的牙周健康和代谢状况，从而预防不良妊娠结局。
NCT，NCT03148483。于2017年5月11日注册。
