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临床试验/NCT01422122
NCT01422122已完成不适用

The Effect of Vitamin D Supplementation on the Periodontal Health and Associated Outcomes in Pregnant Women

Aga Khan University1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
115
试验地点
1
主要终点
Periodontal Probing Depth

研究概览

简要总结

There is a gap in knowledge regarding the effects of Vitamin D supplementation on periodontal status in pregnant wome. The investigators aim to evaluate the potential benefit, if any of vitamin D supplementation during pregnancy on periodontal disease and relevant outcomes including burden of infections and prematurity rates.

the investigators hypothesize that

  1. Vitamin D supplementation during pregnancy improves the periodontal health.
  2. There is an association between inflammatory biomarkers and periodontal health of pregnant females.
  3. Vitamin D supplementation improves the outcomes of pregnancy such as prematurity rates and birth weight

详细描述

Periodontal disease is one of the most common chronic infectious diseases known to humans, with a reported prevalence varying between 10%-60% in adults. Periodontal health is commonly affected in pregnancy. The prevalence of pregnancy gingivitis varies widely, ranging from around 35%- 100%. Although, most of the periodontal changes during pregnancy are reversible but females with preexisting periodontitis or those who have metabolic disease such as diabetes may suffer increased periodontal destruction and may exhibit significantly greater probing pocket depth and attachment level. Periodontal disease, as a source of persistent infection, may induce systemic inflammatory responses that increase the risk of adverse pregnancy outcomes. However, so far the results have been mixed. As vitamin D metabolites may also alter the inflammatory response and have antimicrobial effects thus the use of vitamin D may affect periodontal status. Evidence is there which suggests that an association exists between low serum levels of Vitamin D and periodontal attachment loss. If the investigators take all of the above factors in consideration, the broad picture reveals that as vitamin D deficiency is prevalent in Pakistan, the pregnant females here are likely to have compromised periodontal health and probably poor pregnancy outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant females from 12-20 weeks of gestation who agree to participate in the study.
  • Presence of at least 20 natural teeth in mouth excluding third molars.
  • For controls: Non pregnant, healthy females matched with pregnant with respect to age and education.

排除标准

  • Pregnant females with high Vitamin D levels,
  • Women with metabolic diseases such as diabetes (type 1 or 2).
  • Presence of acute dental or periodontal disease
  • Presence of systemic disease and/or medication affecting the periodontium;
  • Receipt of systemic antibiotic treatment or dental prophylaxis in the previous 3 months and those who do not provide informed consent

研究组 & 干预措施

Vitamin D

Experimental

Oral vitamin D3 in syrup form

干预措施: Vitamin D3 (Drug)

placebo

Placebo Comparator

Placebo syrup identical in colour and taste to that of intervention

干预措施: Placebo (Drug)

结局指标

主要结局

Periodontal Probing Depth

时间窗: 6 months

Periodontal Probing Depth (PPD)is the distance between the gingival margin and the base of the pocket in millimeters). Clinical Attachment Loss (CAL) will also be determined (in mm)

次要结局

  • Interleukin 6 (IL-6) levels(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Farhan Raza Khan

Consultant, Dentistry

Aga Khan University

研究点 (1)

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