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临床试验/NCT04261491
NCT04261491已完成不适用

Impact of Scaling and Root Planing on Systemic Inflammation and Serum Bone Resorption Markers in Postmenopausal Women With Low Bone Mineral Density With Periodontitis.

Postgraduate Institute of Dental Sciences Rohtak4 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
4
主要终点
serum IL-6,

研究概览

简要总结

This study is designed to determine the effect of treating postmenopausal women and using non-surgical techniques on biomarkers of systemic inflammation (IL-6 ) and systemic bone resorption (C-terminal collagen cross-links, CTX).

详细描述

Periodontitis is an inflammatory disease of tooth supporting tissues that is characterized by progressive loss of bone and periodontal attachment and which ultimately leads to tooth loss if left untreated. It is a widespread condition which affects 30% of the adult population. The prevalence increases to greater than 47% among adults age 30 years or older, with those over 65 years old accounting for most cases Osteoporosis is a disease characterized by low bone mineral density(BMD) and deterioration of bone microarchitecture, which leads to increased risk of fragility fractures. It has been reported that one out of two Indian females above the age of 50 years and one out of five Indian men above the age of 65 years are at risk of osteoporosis. It is apparent that both periodontitis and osteoporosis are chronic conditions characterized by resorptive osseous changes with multiple shared risk factors including age, genetics, hormonal change, smoking , as well as calcium and vitamin D deficiency. It has been proposed that the two diseases could also have a mutual relation and this has led to a considerable number of studies investigating the same .Both osteoporosis and periodontitis are more prevalent among elderly population. The number of patients who suffer from both periodontitis and osteoporosis is expected to rise as the average lifespan increases.

Eighty percent of individuals with osteoporosis are women, largely due to the marked loss in bone density associated with the withdrawal of estrogen that accompanies loss of ovarian function at menopause. There is now strong evidence to suggest that systemic pro-inflammatory cytokines in response to estrogen withdrawal at menopause is responsible for increased osteoclastic activity.Systemic Inflammation results in an uncoupling between bone resorption and formation and favours excessive bone resorption resulting in decreased bone mineral density and increased fracture risk in postmenopausal women. Pro-inflammatory cytokines capable of stimulating osteoclastic bone resorption include IL-1, TNF-α, IL-6,IL-11, IL-15 and IL-17. It has been demonstrated that while periodontitis is a local infectious disease of tooth supporting structures, it is also associated with higher inflammatory mediators in the systemic circulation. The data suggest that an individual's overall bone metabolism might be associated with periodontal disease and be reflective of its progression.

Levels of bone turnover markers (BTM) reflect the activity and number of bone forming (osteoblasts) and bone-degrading (osteoclasts) cells, providing an estimate of bone resorption and bone formation. BTM can be measured non-invasively in either blood or urine at a fairly low cost. C-terminal collagen cross-links,CTX, is a bone resorption marker which consists of cross-linked telopeptides from collagen which are released during enzymatic degradation of bone matrix by the osteoclasts Scaling and root planing (SRP) is the most accepted treatment for managing chronic periodontitis and is proven to be effective at controlling local inflammation. Recent research has found evidence that levels of systemic inflammatory markers including IL-1, TNF-α, and IL-6 are also reduced after SRP. Therefore, treatment of periodontal disease results in reduced systemic inflammation but it is unknown if this translates to better outcomes for management of osteoporosis. It is hypothesized that if periodontitis has an influence on bone remodeling, then levels of BTM would also vary with decrease in systemic inflammation owing to resolution of periodontal inflammation following non-surgical periodontal treatment. The purpose of this study is to determine the effect of treating periodontal disease in patients with osteoporosis with scaling and root planing on biomarkers of systemic inflammation (IL-6) and systemic bone turnover (CTX). It is anticipated that the results of this study could be useful in formulating recommendations for interdisciplinary management of patients of concomitant periodontitis and osteoporosis.

MATERIALS AND METHODOLOGY

STUDY DESIGN SETTING: The present prospective interventional study will be conducted in department of Periodontology , Post Graduate institute Dental Sciences,Rohtak.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
52 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

serum IL-6,

时间窗: 2 months

change in serum IL-6,

s-CTX

时间窗: 2 months

change in serum carboxy terminal collagen cross links

次要结局

  • platelet distribution width PDW(2 months)
  • Platelet count(2 months)
  • mean platalet volume(2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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