Emblica Officinalis Irrigation in Periodontitis
Effect of Emblica Officinalis (Amla) as an Adjunct to Scaling and Root Planing in Patients With Chronic Periodontitis
1 other identifier
interventional
112
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 25, 2017
CompletedFirst Posted
Study publicly available on registry
September 27, 2017
CompletedSeptember 28, 2017
September 1, 2017
1.6 years
September 25, 2017
September 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
clinical attachment level
CAL
3 MONTHS
Study Arms (5)
test group
ACTIVE COMPARATORSRP+ 10% Emblica officinalis irrigation
positive control group
ACTIVE COMPARATORSRP + 0.2% Chlorhexidine irrigation
negative control group
ACTIVE COMPARATORSRP + 0.9% Saline irrigation
test gropup
ACTIVE COMPARATORSRP +10% E. officinalis gel application
control group
PLACEBO COMPARATORreceived SRP+ placebo gel application.
Interventions
Eligibility Criteria
You may qualify if:
- :• systemically healthypatients with chronic periodontitis, at least eight sites with probing pocket depth (PPD) ≥5mm
- ≥30 years old,
- ≥ 20 teeth and .
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
shikha Tewari
POST GRADUATE INSTITUTE OF DENTAL SCIENCES
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2017
First Posted
September 27, 2017
Study Start
March 1, 2013
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
September 28, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share