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Emblica Officinalis Irrigation in Periodontitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

Condition or disease Intervention/treatment Phase
Periodontitis 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. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Emblica Officinalis (Amla) as an Adjunct to Scaling and Root Planing in Patients With Chronic Periodontitis
Actual Study Start Date : March 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
Active Comparator: test group
SRP+ 10% Emblica officinalis irrigation
Procedure: SRP+ 10% Emblica officinalis irrigation
Active Comparator: positive control group
SRP + 0.2% Chlorhexidine irrigation
Procedure: SRP + 0.2% Chlorhexidine irrigation)
Active Comparator: negative control group
SRP + 0.9% Saline irrigation
Procedure: SRP + 0.9% Saline irrigation
Active Comparator: test gropup
SRP +10% E. officinalis gel application
Procedure: SRP +10% E. officinalis gel application.
Placebo Comparator: control group
received SRP+ placebo gel application.
Procedure: SRP+ placebo gel application.



Primary Outcome Measures :
  1. clinical attachment level [ Time Frame: 3 MONTHS ]
    CAL



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295461


Locations
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India
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, India, 124001
Sponsors and Collaborators
Postgraduate Institute of Dental Sciences Rohtak
Investigators
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Study Director: shikha Tewari POST GRADUATE INSTITUTE OF DENTAL SCIENCES
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Responsible Party: Postgraduate Institute of Dental Sciences Rohtak
ClinicalTrials.gov Identifier: NCT03295461    
Other Study ID Numbers: perio shikha amla
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants