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Emblica Officinalis Irrigation in Periodontitis

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ClinicalTrials.gov Identifier: NCT03295461
Recruitment Status : Completed
First Posted : September 27, 2017
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
Postgraduate Institute of Dental Sciences Rohtak

Tracking Information
First Submitted Date  ICMJE September 25, 2017
First Posted Date  ICMJE September 27, 2017
Last Update Posted Date September 28, 2017
Actual Study Start Date  ICMJE March 2013
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2017)
clinical attachment level [ Time Frame: 3 MONTHS ]
CAL
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Emblica Officinalis Irrigation in Periodontitis
Official Title  ICMJE Effect of Emblica Officinalis (Amla) as an Adjunct to Scaling and Root Planing in Patients With Chronic Periodontitis
Brief 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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Periodontitis
Intervention  ICMJE
  • Procedure: SRP+ 10% Emblica officinalis irrigation
  • Procedure: SRP + 0.2% Chlorhexidine irrigation)
  • Procedure: SRP + 0.9% Saline irrigation
  • Procedure: SRP +10% E. officinalis gel application.
  • Procedure: SRP+ placebo gel application.
Study Arms  ICMJE
  • Active Comparator: test group
    SRP+ 10% Emblica officinalis irrigation
    Intervention: Procedure: SRP+ 10% Emblica officinalis irrigation
  • Active Comparator: positive control group
    SRP + 0.2% Chlorhexidine irrigation
    Intervention: Procedure: SRP + 0.2% Chlorhexidine irrigation)
  • Active Comparator: negative control group
    SRP + 0.9% Saline irrigation
    Intervention: Procedure: SRP + 0.9% Saline irrigation
  • Active Comparator: test gropup
    SRP +10% E. officinalis gel application
    Intervention: Procedure: SRP +10% E. officinalis gel application.
  • Placebo Comparator: control group
    received SRP+ placebo gel application.
    Intervention: Procedure: SRP+ placebo gel application.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2017)
112
Original Actual Enrollment  ICMJE
 (submitted: September 25, 2017)
66
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

:• systemically healthypatients with chronic periodontitis, at least eight sites with probing pocket depth (PPD) ≥5mm

  • ≥30 years old,
  • ≥ 20 teeth and .

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03295461
Other Study ID Numbers  ICMJE perio shikha amla
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Postgraduate Institute of Dental Sciences Rohtak
Study Sponsor  ICMJE Postgraduate Institute of Dental Sciences Rohtak
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: shikha Tewari POST GRADUATE INSTITUTE OF DENTAL SCIENCES
PRS Account Postgraduate Institute of Dental Sciences Rohtak
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP