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临床试验/CTRI/2024/11/076146
CTRI/2024/11/076146尚未招募4 期

Impact of Vitamin D supplementation in postmenopausal women with stage II periodontitis after nonsurgical periodontal therapy

Deepa Anumala1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月9日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
serum vitamin D levels, alveolar crest changes

研究概览

简要总结

Increased bone resorption due to decreased sex hormones in the first decade after menopause is a common problem in women.  Increasing attention has been paid in recent years to moderate vitamin D deficiency especially in postmenopausal women.  Vitamin D role in periodontitis is biologically assosiated and supported by experimental and clinical evidence showing its influence on inflammation, bone metabolism.   Vitamin D affects both the immune system and the bone mineral mass, which may lead to progression of periodontal disease in post menopausal women. Recent systematic review, given by Machado et al. stated that 25-hydroxyvitamin D serum levels were significantly lower in chronic periodontitis patients compared with healthy controls. They also concluded that owing to the low number of studies, ascription of periodontitis and vitamin D levels after non-surgical periodontal treatment is not simple. Factors that influence 25-hydroxyvitamin D concentration have been evaluated with considerable attention.Postmenopausal women with osteoporosis had lower serum 25OHD3 levels compared with age-matched controls without osteoporosis. Lowered serum 25OHD3 was also associated with periodontal disease and elevated levels of RANKL and osteoprotegerin (OPG). Non-surgical periodontal therapy (NSPT) with scaling and root planing is the most common treatment of periodontitis, which results in improvement of periodontal parameters.  There is limited data on variations of vitamin D levels in postmenopausal women after NSPT with vitamin D supplements. Therefore, this study aimed to assess the association of Periodontal parameters like Gingival index(GI),Plaque index(PI)Pocket depth(PD),Alveolar Crest Height(ACH)  and serum vitamin D levels at baseline and 3 months in postmenopausal women with Stage II Peridontitis after Non surgical periodontal therapy with or without vitamin D supplementation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
55.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • Postmenopausal women with atleast 5 years of menopause will be chosen for the study.Women in good general health, not suffering from any systemic disorder or condition will be selected for the study.Women who practice routine brushing habits and chew on both sides.

排除标准

  • Patients taking estrogen, corticosteroids, nonsteroidal anti-inflammatory drugs , antibiotics, vitamin D, lithium, thiazide diuretics, and thyroxine with in the past one month Patients suffering from kidney failure, diabetes mellitus, Paget’s disease, cardiac diseases which would interfere with bone metabolism and immune system.
  • Patients who had undergone periodontal therapy with in past 6 months.Patients with third molars.

结局指标

主要结局

serum vitamin D levels, alveolar crest changes

时间窗: baseline, 3 months

次要结局

  • gingival index, plaque index, pocket depth(baseline, 3 months)

研究者

发起方
Deepa Anumala
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Deepa Anumala

SIBAR Institute of dental sciences

研究点 (1)

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