دورية أكاديمية
Calcium and vitamin D supplementation and/or periodontal therapy in the treatment of periodontitis among Brazilian pregnant women: protocol of a feasibility randomised controlled trial (the IMPROVE trial).
| العنوان: | Calcium and vitamin D supplementation and/or periodontal therapy in the treatment of periodontitis among Brazilian pregnant women: protocol of a feasibility randomised controlled trial (the IMPROVE trial). |
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| المؤلفون: | Cocate PG; 1Department of Bioscience and Physical Activity, School of Physical Education and Sports, Rio de Janeiro Federal University, Rio de Janeiro, Brazil., Kac G; 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., Heitmann BL; 3Research Unit for Dietary Studies at the Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region, Denmark and Section for General Medicine, Institute of Public Health, Copenhagen, Denmark., Nadanovsky P; 4Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro, Brazil., da Veiga Soares Carvalho MC; 5Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Rio de Janeiro Federal University, Rio de Janeiro, Brazil., Benaim C; 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., Schlüssel MM; 6Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK., de Castro MBT; 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., Alves-Santos NH; 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., Baptista AF; 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., Holick MF; 7Section of Endocrinology, Diabetes & Nutrition, Department of Medicine, Boston University School of Medicine (BUSM), Boston, MA USA., Mokhtar RR; 8Boston University School of Medicine (BUSM), Boston, MA USA., Bomfim AR; 4Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro, Brazil., Adegboye ARA; 9Department of Psychology, Social Work & Counselling, Faculty of Education and Health, University of Greenwich, Old Royal Naval College, Park Row, London, SE10 9LS UK. |
| المصدر: | Pilot and feasibility studies [Pilot Feasibility Stud] 2019 Mar 05; Vol. 5, pp. 38. Date of Electronic Publication: 2019 Mar 05 (Print Publication: 2019). |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: BioMed Central Country of Publication: England NLM ID: 101676536 Publication Model: eCollection Cited Medium: Print ISSN: 2055-5784 (Print) Linking ISSN: 20555784 NLM ISO Abbreviation: Pilot Feasibility Stud Subsets: PubMed not MEDLINE |
| أسماء مطبوعة: | Original Publication: London : BioMed Central, [2015]- |
| مستخلص: | Background: 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. Methods: 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 ( n = 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. Discussion: 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. Trial Registration: NCT, NCT03148483. Registered on May 11, 2017. Competing Interests: The study was presented to and approved by the director of the health centre where it is being conducted. Recruitment started after the IMPROVE trial protocol was submitted and approved by the Ethics Committee of School Maternity of the Federal University of Rio de Janeiro-Brazil on April 27, 2016 (certificate number 1.516.656). The study is being conducted according to the principles of Good Clinical Practice and the Declaration of Helsinki. Explanation of study procedures is given verbally to all participants and a written copy is provided in the patient information sheet. Study participation began after receipt of informed written consent. The trial was registered in the ClinicalTrials.gov database (NCT, NCT03148483. Registered 11 May 2017, https://clinicaltrials.gov/ct2/show/NCT03148483) and its recruitment began on May 2017.No applicable.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. |
| التعليقات: | Erratum in: Pilot Feasibility Stud. 2020 Nov 27;6(1):187. (PMID: 33292810) |
| References: | Nutrition. 2001 Feb;17(2):177-8. (PMID: 11240353) Am J Med. 2001 Oct 15;111(6):452-6. (PMID: 11690570) Cad Saude Publica. 2005 May-Jun;21(3):703-14. (PMID: 15868028) Community Dent Oral Epidemiol. 2005 Aug;33(4):307-14. (PMID: 16008638) N Engl J Med. 2006 Nov 2;355(18):1885-94. (PMID: 17079762) Cad Saude Publica. 2007 Nov;23(11):2577-88. (PMID: 17952250) Ann Intern Med. 2008 Feb 19;148(4):295-309. (PMID: 18283207) J Am Dent Assoc. 2008 Jun;139(6):685-95. (PMID: 18519992) BMJ. 2008 Nov 11;337:a2390. (PMID: 19001484) Obstet Gynecol. 2009 Sep;114(3):551-9. (PMID: 19701034) Clin Chim Acta. 2009 Nov;409(1-2):117-22. (PMID: 19751716) J Indian Soc Periodontol. 2009 Sep;13(3):145-9. (PMID: 20379412) Obstet Gynecol. 2010 May;115(5):1063-70. (PMID: 20410783) Nutr Rev. 2010 Aug;68(8):465-77. (PMID: 20646224) J Dent Res. 2011 Mar;90(3):289-93. (PMID: 21041548) Arch Gynecol Obstet. 2011 Apr;283(4):675-86. (PMID: 21120511) Public Health Nutr. 2011 May;14(5):785-92. (PMID: 21129236) Sleep Med. 2011 Jan;12(1):70-5. (PMID: 21145786) J Oral Microbiol. 2011 Jan 17;3:null. (PMID: 21547019) J Appl Oral Sci. 2011 Apr;19(2):130-6. (PMID: 21552714) Am J Obstet Gynecol. 2011 Aug;205(2):111.e1-6. (PMID: 21620355) J Bone Miner Res. 2011 Oct;26(10):2341-57. (PMID: 21706518) J Clin Periodontol. 2011 Sep;38(9):795-808. (PMID: 21707694) J Nat Sci Biol Med. 2010 Jul;1(1):40-2. (PMID: 22096335) Reprod Health. 2012 Jan 24;9:3. (PMID: 22273008) J Periodontol. 2012 Nov;83(11):1388-96. (PMID: 22309175) Cochrane Database Syst Rev. 2012 Feb 15;(2):CD008873. (PMID: 22336854) Nutrition. 2012 Jul;28(7-8):779-84. (PMID: 22459555) Public Health Nutr. 2013 Aug;16(8):1419-26. (PMID: 22895030) J Periodontol. 2013 Jul;84(7):857-62. (PMID: 23075430) J Periodontol. 2013 Sep;84(9):1257-65. (PMID: 23106510) Nutrients. 2012 Sep;4(9):1219-29. (PMID: 23112910) Food Nutr Res. 2012;56:null. (PMID: 23185146) J Clin Endocrinol Metab. 2013 Jun;98(6):2337-46. (PMID: 23559082) Am J Clin Nutr. 2013 Jul;98(1):82-91. (PMID: 23719547) Lancet. 2013 Aug 3;382(9890):417-425. (PMID: 23746775) J Periodontal Res. 2014 Aug;49(4):458-64. (PMID: 23947938) J Indian Soc Periodontol. 2013 May;17(3):302-8. (PMID: 24049329) BMJ. 2014 Mar 07;348:g1687. (PMID: 24609605) Trials. 2014 Jul 03;15:264. (PMID: 24993581) Clin Endocrinol (Oxf). 2015 Sep;83(3):363-8. (PMID: 25727810) Ceska Gynekol. 2015 Aug;80(4):290-8. (PMID: 26265417) J Clin Diagn Res. 2015 Jun;9(6):ZC35-8. (PMID: 26266214) Int J Prev Med. 2016 Mar 01;7:49. (PMID: 27076887) Rev Bras Ter Intensiva. 2016 Sep;28(3):256-260. (PMID: 27737421) Pan Afr Med J. 2016 Jul 12;24:215. (PMID: 27800070) Eur J Nutr. 2018 Apr;57(3):1059-1072. (PMID: 28353072) PLoS One. 2017 May 19;12(5):e0178234. (PMID: 28538740) Int J Health Sci (Qassim). 2017 Apr-Jun;11(2):72-80. (PMID: 28539867) Cochrane Database Syst Rev. 2017 Jun 12;6:CD005297. (PMID: 28605006) J Am Dent Assoc. 1997 Sep;128(9):1263-71. (PMID: 9297948) Crit Rev Oral Biol Med. 1998;9(3):248-66. (PMID: 9715365) |
| فهرسة مساهمة: | Keywords: Calcium; Feasibility randomised controlled trial; Milk; Periodontal therapy; Pregnant women; Vitamin D |
| سلسلة جزيئية: | ClinicalTrials.gov NCT03148483 |
| تواريخ الأحداث: | Date Created: 20190316 Latest Revision: 20220408 |
| رمز التحديث: | 20231215 |
| مُعرف محوري في PubMed: | PMC6402123 |
| DOI: | 10.1186/s40814-019-0417-6 |
| PMID: | 30873290 |
| قاعدة البيانات: | MEDLINE |
Find this article in full text from Springer Verlag. 
Full Text Finder | تدمد: | 2055-5784 |
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| DOI: | 10.1186/s40814-019-0417-6 |