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临床试验/CTRI/2022/04/042292
CTRI/2022/04/042292已完成不适用

EFFECT OF PERIODONTAL THERAPY ON THE SALIVARY LEVELS OF RESOLVINS(RvE1) AND LIPOXINS(LXA4) IN PERIODONTITIS PATIENTS

ARTHI I1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年5月5日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
SALIVARY LEVELS OF RESOLVIN AND LIPOXIN BEFORE AND AFTER NON-SURGICAL PERIODONTAL THERAPY

研究概览

简要总结

Periodontitis is an immunoinflammatorydisease of the supporting structures of the dentition which is initiated by perio-pathogens that triggers the cellsof the immune system to release proinflammatory mediators resulting ininflammation and destruction of the periodontium. The primary goal of the periodontaltherapy is to ensure resolution of inflammation and restoration of the tissuehomeostasis. Cigarette smoking is known to be a majorrisk factor for periodontal disease and also affects the healing response of patientsafter periodontal therapy. A ‘programmed resolution’ at the tissuelevel has been actively driven by several specialized lipid immune resolventsincluding resolvins and lipoxins. The role of resolvins and lipoxins in response to non-surgicalperiodontal therapy has not been elucidated in smokers with periodontitis.Further, salivary levels of resolvins (RvE1) and lipoxins (LXA4) andtheir association with periodontal therapy among smokers and non-smokers hasnot been studied. Therefore, in this study, we aim toevaluate and compare the salivary levels of resolvins (RvE1) and lipoxins (LXA4) inperiodontitis patients before and after non-surgical treatment between smokersand non-smokers. Most metabolites, cytokines, products ofinflammation including RvE1 and LXA4 ongoing in periodontium move in a certainamount by passive filtration into saliva and their levels in saliva reflecttheir levels in plasma.

研究设计

研究类型
Observational

入排标准

年龄范围
35.00 Year(s) 至 65.00 Year(s)(—)
性别
Male

入选标准

  • 1.Patients with more than 20 teeth 2.Current cigarette smokers ≤ 10 cigarettes per day 3.Periodontitis patients with probing pocket depth(PPD) ≥ 5mm and interdental clinical attachment level(CAL) ≥4mm 4.Patients who are complying with oral hygiene instructions and periodontal recall 5.Patients who are willing to participate in the study.

排除标准

  • 1.Pregnant and lactating women 2.Patients using medication affecting the periodontal status.
  • 3.Patients with history of periodontal therapy for the past six months 4.Patients with inflammatory disorders such as rheumatoid arthritis, diabetes mellitus, COPD, inflammatory bowel disease etc.

结局指标

主要结局

SALIVARY LEVELS OF RESOLVIN AND LIPOXIN BEFORE AND AFTER NON-SURGICAL PERIODONTAL THERAPY

时间窗: AT BASELINE AND 4 WEEKS AFTER NON SURGICAL PERIODONTAL THERAPY

次要结局

  • To compare the salivary levels of resolvins and lipoxins before and after non-surgical periodontal therapy between smokers and non-smokers and to correlate it with clinical parameters.

研究者

发起方
ARTHI I
申办方类型
Other [Self funded]

研究点 (1)

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