跳至主要内容
临床试验/NCT03295461
NCT03295461已完成不适用

Effect of Emblica Officinalis (Amla) as an Adjunct to Scaling and Root Planing in Patients With Chronic Periodontitis

Postgraduate Institute of Dental Sciences Rohtak2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
112
试验地点
2
主要终点
clinical attachment level

研究概览

简要总结

E. officinalis fruit possesses both the antimicrobial and anti-inflammatory activities that may prove to be useful against several periodontal diseases with the advantage that it is devoid of side effects associated with synthetic drugs. After the careful search of literature, none of the studies have reported the effect of local drug delivery of E. officinalis preparations on chronic periodontitis.The present study is designed with the aim of assessing the effectiveness of Emblica officinalis extract formulations as a potential adjunctive therapeutic strategy in the management of chronic periodontititis

详细描述

The presence of bacterial plaque represents the principal etiologic factor involved in the initiation of inflammatory periodontal diseases and the destructive host responses triggered by microbial pathogens exaggerate the already existing condition resulting in connective tissue loss characterizing the inflammatory periodontal diseases . The key element of periodontal therapy is to achieve a significant reduction or eradication of suspected periodontal pathogens as well as modulation of destructive host responses.

Chlorhexidine has been extensively employed adjunctive to conventional mechanical treatment for chronic periodontitis. But its use is limited by various side effects, including development of resistance, decrease in saliva secretion, acceleration in calculus accumulation, altered taste perception and teeth staining Researchers are increasingly turning their attention to phyto-therapeutic agents and looking for new leads to develop better drugs against multidrug resistant microbial strains. Bacteria are less likely to develop resistance to these natural substances, which should be safer for patients and cause fewer side effects.

Emblica officinalis Gaertn. or Phyllanthus emblica Linn belongs to the family Euphorbiaceae. All parts of the plant are of use in treating various ailments, but the fruit is of immense use in various traditional systems of medicine as it possesses a wide array of activities such as antibacterial, anti-inflammatory, analgesic, antioxidant, immunomodulatory, antibacterial, antipyretic, antidiabetic, hypolipidaemic, cardioprotective, antiresorptive properties. E. officinalis fruit is one of the richest sources of Vitamin C (600mg/100g) and contains water, proteins, carbohydrates, fibres, minerals, zinc, chromium, copper, gallic acid. The antimicrobial property of E. officinalis fruit is attributed mainly to flavonoids, phenols, saponins and tannins. Saponins and tannins proved to have a potent anti-microbial property . Phenolic compounds of Emblica officinalis also ameliorate acute and chronic inflammation due to their modulatory action on free radicals and by affecting COX (Cyclo-oxygenase) pathway, specifically prostaglandins. Thus ,it was hypothesized that adjunctive use of E. officinalis along with nonsurgical periodontal treatment may improve periodontal tissue healing and /or treatment outcomes of chronic periodontitis.

Materials and methods:

The study was conducted in department of Periodontics and Oral Implantology, Post Graduate Institute of Dental Sciences (PGIDS), Rohtak in collaboration with College of Pharmacy and Department of Microbiology, Post Graduate Institute of Medical Sciences (PGIMS), Rohtak. This study was designed according to the ethical standards outlined in the 1964 Declaration of Helsinki, as revised in 2008. The study got approval from Institutional Review Board, PGIDS, Rohtak (PGIDS/2013/IEC/87) and ethical committee of PGIDS, Rohtak. The study continued from March 2013 to October 2014 and CONSORT guidelines for the randomized clinical trials were followed.

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
Double (Participant, Investigator)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • presence of systemic illnesses (diabetes mellitus, immunocompromised states), which affect the outcome of periodontal therapy,
  • history of periodontal therapy and use of antibiotics or antiinflammatory drugs in the preceding 6 months,
  • allergy to gel components,
  • aggressive periodontitis,
  • pregnancy or lactation,
  • smokers(current/former), alcohol or drug abuse.

结局指标

主要结局

clinical attachment level

时间窗: 3 MONTHS

CAL

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验