EFFECT OF SCALING ON SERUM hsCRP LEVELS AND PERIODONTAL PARAMETERS IN SYSTEMICALLY HEALTHY WOMEN OF REPRODUCTIVE AGE GROUP WITH GINGIVITIS: AN INTERVENTIONAL STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- plaque index
研究概览
简要总结
Gingivitis is a highly prevalent chronic bacterial disease in susceptible children, adults and the elderly, persisting for decades in subjects, and is an essential precursor of periodontitis. Several studies have shown periodontitis and subgingival P. gingivalis to be associated with increased C-reactive protein (CRP) levels and CRP has been implicated as a possible mediator of the association between periodontitis and several systemic diseases Limited data are available today addressing detrimental systemic effects of experimental or natural gingivitis as they have been rarely investigated. Results of various studies support the concept that gingivitis leads to systemic inflammation and that the level of systemic inflammatory markers increases proportionately with increase in gingival inflammation. It has also been seen that appropriate dental prophylaxis can also limit systemic markers of inflammation in subjects with natural gingivitis. Sex hormones have long been considered to play an influential role on periodontal tissues, bone turnover rate, wound healing and periodontal disease progression and can influence the cellular proliferation, differentiation and growth of keratinocytes and fibroblasts. Estrogen is mainly responsible for alterations in blood vessels and progesterone stimulates the production of inflammatory mediators. In addition, some micro-organisms found in the human mouth synthesize enzymes needed for steroid synthesis and catabolism. Sex hormones are neither necessary nor sufficient to produce gingival changes by themselves. However, they may alter periodontal tissue responses to microbial plaque and thus indirectly contribute to periodontal disease. (Markou). Till date, no study has been conducted assessing the serum hsCRP levels in females of reproductive age group with gingivitis. This study, thus, aims to assess the effect of scaling on serum hsCRP levels and periodontal parameters in systemically healthy women of reproductive age group with gingivitis.
详细描述
Gingivitis is a highly prevalent chronic bacterial disease in susceptible children, adults and the elderly, persisting for decades in subjects, and is an essential precursor of periodontitis. Several studies have shown periodontitis and subgingival P. gingivalis to be associated with increased C-reactive protein (CRP) levels and CRP has been implicated as a possible mediator of the association between periodontitis and several systemic diseases Limited data are available today addressing detrimental systemic effects of experimental or natural gingivitis as they have been rarely investigated. Results of various studies support the concept that gingivitis leads to systemic inflammation and that the level of systemic inflammatory markers increases proportionately with increase in gingival inflammation. It has also been seen that appropriate dental prophylaxis can also limit systemic markers of inflammation in subjects with natural gingivitis. Sex hormones have long been considered to play an influential role on periodontal tissues, bone turnover rate, wound healing and periodontal disease progression and can influence the cellular proliferation, differentiation and growth of keratinocytes and fibroblasts. Estrogen is mainly responsible for alterations in blood vessels and progesterone stimulates the production of inflammatory mediators. In addition, some micro-organisms found in the human mouth synthesize enzymes needed for steroid synthesis and catabolism. Sex hormones are neither necessary nor sufficient to produce gingival changes by themselves. However, they may alter periodontal tissue responses to microbial plaque and thus indirectly contribute to periodontal disease. (Markou). Till date, no study has been conducted assessing the serum hsCRP levels in females of reproductive age group with gingivitis. This study, thus, aims to assess the effect of scaling on serum hsCRP levels and periodontal parameters in systemically healthy women of reproductive age group with gingivitis.RESEARCH QUESTION What is the effect of scaling on serum hsCRP levels and periodontal parameters in systemically healthy women of reproductive age group with gingivitis?
- P -population-systemically healthy women,18-40 years of age having gingivitis.
- I-intervention- Scaling
- C -control/comparison- before and after scaling among systemically healthy women with gingivitis and also with systemically healthy women with healthy periodontium
- O -outcome- plaque index (PI), gingival index (GI), Bleeding on probing (BOP) and serum hsCRP levels
- T- time frame- 6 months
FINER
- F- feasibility- all the facilities required are present in the department.
- I-interesting-impact of scaling on systemic inflammation and periodontal status in women of reproductive age with gingivitis
- N-novelty- very little evidence available
- E-ethical-no ethical issues
- R-relevant-results of the study can help in further strengthening the link between local inflammatory burden and systemic inflammation by observing the effect of scaling on periodontium and systemic markers of inflammation and formulating recommendations for early periodontal care of the patients.
AIM - to assess the effect of scaling on serum hsCRP levels and periodontal parameters in systemically healthy women of reproductive age group with gingivitis.
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
- Single (Investigator)
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •females of reproductive age group (18-40 yrs)
- •BMI (18.5 - 24.9)
- •presence of ≥20 natural teeth
- •Healthy periodontium (for control group) defined as bleeding on probing at < 10% of sites, with pockets ≤3 mm, no probing attachment loss and no radiologic bone loss.
- •Gingivitis (17) (for test group) Gingivitis (intact periodontium) is defined as bleeding on probing at ≥ 10% of sites, with pockets ≤3 mm, no probing attachment loss and no radiologic bone loss.
- •Gingivitis (reduced periodontium) is defined as bleeding on probing at ≥ 10% of sites with pockets ≤3 mm with possible probing attachment loss and possible radiologic bone loss.
- •Localized gingivitis is defined as 10-30% of bleeding sites. Generalized gingivitis is defined as more than 30% of bleeding sites.
排除标准
- •history of androgen-secreting tumors, congenital adrenal hyperplasia and thyroid dysfunction
- •nephrotic syndrome, chronic renal failure, significant cardiovascular disease, established type 1 or type 2 diabetes mellitus, active cancer within the last past 5 years
- •smokers and alcoholics
- •history of systemic antibiotics or oral contraceptives usage within last 3 months
- •periapical pathology or oral inflammatory conditions other than gingivitis.
- •any periodontal treatment within 6 months prior to study Patients with pockets ≥ 3 mm and probing attachment loss shall be excluded, hence, radiographic examination will not be needed.
研究组 & 干预措施
systemically healthy females with gingivitis
scaling will be done at baseline
干预措施: SCALING (Procedure)
systemically and periodontally healthy females
data will be recorded at baseline and no intervention will be done
结局指标
主要结局
plaque index
时间窗: 6 months
plaque index will be measured on 4 sites per tooth in all the teeth
gingival index
时间窗: 6 months
gingival index will be measured on 4 sites per tooth in all the teeth
bleeding on probing
时间窗: 6 months
bleeding on probing will be measured on 6 sites per tooth in all the teeth
serum high sensitivity c reactive protein
时间窗: 6 months
serum high sensitivity C reactive protein will be measured at baseline and at 6 months
次要结局
未报告次要终点