Emblica Officinalis Irrigation in Periodontitis
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      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
    

Detailed description: 
      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.

      Study population: The study patients were enrolled from systemically healthy individuals
      attending regular outpatient department of Periodontics and Oral Implantology, PGIDS, Rohtak.

      Study design included a single-center, double-blinded randomized clinical trial in two parts.

      Part I :test group (n = 23, 264 sites) received scaling and root planing (SRP) +10% E.

      officinalis gel application and control group (n = 23, 264 sites) received SRP+ placebo gel
      application.

      Part II:test group (SRP+ 10% Emblica officinalis irrigation), positive control group (SRP +
      0.2% Chlorhexidine irrigation), negative control group (SRP + 0.9% Saline irrigation)

      Periodontal examination: After inclusion into the study, all patients underwent full-mouth
      periodontal examination in a standardized way using a mouth mirror, tweezer, Williams probe
      (Hu-Friedy, Chicago, IL.) and explorer. Following parameters were considered: Primary outcome
      variables including Probing Depth (PD), Clinical Attachment Level (CAL) and secondary outcome
      variables including Plaque Index (PI) , Gingival Index (GI) , Sulcus Bleeding Index (SBI) .

      Preparation of E. officinalis extract: The authenticated plant material E.officinalis fruits
      (herbal garden, College of Pharmacy, Post Graduate Institute of Medical Sciences, Rohtak)
      were collected, washed and shade dried at room temperature. E. officinalis extract was
      prepared using the methodology according to Kokate, 2008 and 10% concentration of E.
      officinalis extract was finalized for subgingival gel/ irrigation in the present study.

      Preparation of Emblica officinalis extract (Euphorbiaceae). The authenticated plant material
      E. officinalis fruits (herbal garden, College of Pharmacy, Post Graduate Institute of Medical
      Sciences, Rohtak) were collected, washed and shade dried at room temperature. A total of 500
      g of powdered shade dried fruits of E. officinalis were extracted exhaustively with water and
      ethanol mixture without soaking. This suspension of powdered drug and hydroalcoholic mixture
      (1:1 ratio of water and ethanol) in sterile conical flask was then placed on magnetic stirrer
      at 50°C temperature for 4 h. Then the supernatant filtered by using Whatman filter paper, and
      the filterate was finely dried by using rotary film evaporator operating at 60 °C temperature
      and 75 rpm . This converted the extract into dried powder form, which was used for the gel
      formulation.

      Preliminary antimicrobial and antiinflammatory screening - In this study, the authors
      assessed zones of inhibition and minimum inhibitory concentrations of E. officinalis
      hydroalcoholic extract against Streptococcus mutans (MTCC 497), Streptococcus oralis (MTCC
      2696), Enterococcus fecalis (ATCC 29212), Pseudomonas aeruginosa (ATCC 27853) and
      Staphylococcus aureus (ATCC 25923) by agar diffusion and broth dilution tests, respectively.
      Zones of inhibition ranged between 10 and 28mm at 10% concentration of extract while minimum
      inhibitory concentration between 0.5% and 2% against tested micro-organisms. Antiinflammatory
      activity of extract was assessed by human red blood cell membrane stabilization method in
      vitro. Based upon these findings, 10%concentration of E. officinalis extract was finalized
      for subgingival application in the present study.

      Periodontal treatment: Patients received non-surgical treatment in the form of full mouth
      supragingival and subgingival scaling and root planing (SRP) in 2-3 sessions .In part I of
      the study application of placebo gel and 10% E. officinalis gel in deep pockets of control
      and test group patients, respectively, in part II of the study singal application of
      subgingival irrigation with 0.9% saline, 0.2% chlorhexidine and 10% E. officinalis irrigant
      was performed in negative control group, positive control group and test group respectively,
      on the day of completion of SRP by another investigator (ST). The subgingival irrigation was
      accomplished by applying 5 ml irrigant to all the periodontal sites in both arches with the
      use of a syringe and blunted needle placed as close as possible to the bottom of the pocket.
      The patients were instructed to use only mechanical techniques to clean teeth during the
      study period and mouthwashes and /or antimicrobials were not prescribed. All the periodontal
      parameters were recorded at baseline and after 2 and 3 months of follow up period by a single
      periodontist (SG).
    

Intervention name(s): SRP+ 10% Emblica officinalis irrigation; SRP + 0.2% Chlorhexidine irrigation); SRP + 0.9% Saline irrigation; SRP +10% E. officinalis gel application.; SRP+ placebo gel application.
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Procedure
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment