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临床试验/CTRI/2021/08/035891
CTRI/2021/08/035891尚未招募1/2 期

EVALUATION OF ALKALINE PHOSPHATASE LEVELS IN SALIVA AND SERUM OF CHRONIC PERIODONTITIS PATIENTS: A CLINICO-BIOCHEMICAL STUDY

Preeti Singh1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年8月30日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Salivary ALP level

研究概览

简要总结

Of the various illnesses that affect teeth, periodontitis is a common disease results in the destruction of supporting structures of the teeth, ultimately which cause tooth loss. Although periodontitis is an infectious disease of gingival tissue origin, changes that occur

in the bone are crucial as the alveolar bone destruction is responsible for tooth loss. The most common cause of alveolar bone destruction in periodontitis is the extension of inflammation from the marginal gingiva to the underlying periodontal tissues.

Salivary constituents for diagnosing periodontal disease include enzymes and immunoglobulins, hormones of host origin, bacteria and bacterial products, ions, and volatile compounds.

Alkaline Phosphatase is a hydrolase enzyme responsible for removing phosphate groups from many types of molecules and is a marker of bone metabolism. It is a membrane‑bound glycoprotein produced by a various number of cells, such as polymorphonuclear

leukocytes, macrophages, fibroblasts, and osteoblasts, within the area of the periodontium and gingival crevice. Various studies have assessed the levels of salivary ALP with respect to gingivitis, chronic periodontitis, and correlation of the same with clinical parameters. However, there was lagging evidence regarding the comparative effects of ALP in serum and saliva following periodontal treatment.

The purpose of this study is to compare the serum and salivary alkaline phosphatase levels before and after phase 1 periodontal therapy which serve to hold to the hypothesis that saliva can be used as an alternative to serum for evaluating alkaline phosphatase as a biomarker in periodontal disease progression. It will be one of the first study which focuses on the comparison between salivary and serum alkaline phosphatase levels before and after phase 1 periodontal therapy in healthy and chronic periodontitis patients.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
25.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Subjects with at least 25 years of age (25-55 years) Subjects who have given written consent Subjects who will be available for follow-up •For Control Group: Participants with at least 20 natural teeth and probing pocket depth of 2-3 mm with no attachment loss and bleeding on probing with <20% sites.
  • For Study Group: Participants had to have 5 qualifying sites in 2 quadrants with a minimum of 2 affected teeth in each quadrant with each site having probing depth ≥ 5 mm, CAL ≥ 3 mm, bleeding on probing.

排除标准

  • Any history of metabolic or systemic disease History of irradiation in the head or neck area Smokers Pregnant or lactating women Has not undergone any periodontal therapy for past 1 year Patients who are not maintaining their oral hygiene and patients lacking motivation during phase 1 therapy.

结局指标

主要结局

Salivary ALP level

时间窗: At baseline and 1 month after therapy

Serum ALP level

时间窗: At baseline and 1 month after therapy

GCF ALP level

时间窗: At baseline and 1 month after therapy

次要结局

  • Gingival Index (Loe & Silness)(Plaque Index (Silness & Loe))

研究者

发起方
Preeti Singh
申办方类型
Government medical college

研究点 (1)

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