PeriodontitisNCT03295461
Emblica Officinalis Irrigation in Periodontitis
A study testing SRP+ 10% Emblica officinalis irrigation, SRP + 0.2% Chlorhexidine irrigation) and SRP + 0.9% Saline irrigation in people with Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- SRP+ 10% Emblica officinalis irrigation, SRP + 0.2% Chlorhexidine irrigation) and SRP + 0.9% Saline irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- :• systemically healthypatients with chronic periodontitis, at least eight sites with probing pocket depth (PPD) ≥5mm
- ≥30 years old,
- ≥ 20 teeth and .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Emblica Officinalis (Amla) as an Adjunct to Scaling and Root Planing in Patients With Chronic Periodontitis
- 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
Read the 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).
- Conditions
- Periodontitis
- Being tested
- 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.
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRP+ 10% Emblica officinalis irrigationProcedure or surgery
SRP + 0.2% Chlorhexidine irrigation)Procedure or surgery
SRP + 0.9% Saline irrigationProcedure or surgery
SRP +10% E. officinalis gel application.Procedure or surgery
SRP+ placebo gel application.Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| test group | Active comparator | SRP+ 10% Emblica officinalis irrigation Receives: Procedure: SRP+ 10% Emblica officinalis irrigation |
| positive control group | Active comparator | SRP + 0.2% Chlorhexidine irrigation Receives: Procedure: SRP + 0.2% Chlorhexidine irrigation) |
| negative control group | Active comparator | SRP + 0.9% Saline irrigation Receives: Procedure: SRP + 0.9% Saline irrigation |
| test gropup | Active comparator | SRP +10% E. officinalis gel application Receives: Procedure: SRP +10% E. officinalis gel application. |
| control group | Placebo comparator | received SRP+ placebo gel application. Receives: Procedure: SRP+ placebo gel application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical attachment level
CAL
Measured: 3 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study startMar 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- shikha Tewari, Study director, Post Graduate Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295461
- Sponsor's protocol ID
- perio shikha amla
- Status last verified
- Sep 2017
- First submitted
- 25 Sep 2017
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Emblica Officinalis (Amla) as an Adjunct to Scaling and Root Planing in Patients With Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT03295461
- Acronym / sponsor ID
- perio shikha amla
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 27 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| test group | Active comparator | Procedure: SRP+ 10% Emblica officinalis irrigationSRP+ 10% Emblica officinalis irrigation |
| positive control group | Active comparator | Procedure: SRP + 0.2% Chlorhexidine irrigation)SRP + 0.2% Chlorhexidine irrigation |
| negative control group | Active comparator | Procedure: SRP + 0.9% Saline irrigationSRP + 0.9% Saline irrigation |
| test gropup | Active comparator | Procedure: SRP +10% E. officinalis gel application.SRP +10% E. officinalis gel application |
| control group | Placebo comparator | Procedure: SRP+ placebo gel application.received SRP+ placebo gel application. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- :• systemically healthypatients with chronic periodontitis, at least eight sites with probing pocket depth (PPD) ≥5mm
- ≥30 years old,
- ≥ 20 teeth and .
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRP+ 10% Emblica officinalis irrigation | Procedure or surgery | test group |
| SRP + 0.2% Chlorhexidine irrigation) | Procedure or surgery | positive control group |
| SRP + 0.9% Saline irrigation | Procedure or surgery | negative control group |
| SRP +10% E. officinalis gel application. | Procedure or surgery | test gropup |
| SRP+ placebo gel application. | Procedure or surgery | control group |
Primary outcome
clinical attachment level
Time frame: 3 MONTHS
CAL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
shikha Tewari study director
Post Graduate Institute of Dental Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SRP+ 10% Emblica officinalis irrigation, SRP + 0.2% Chlorhexidine irrigation) and SRP + 0.9% Saline irrigation in people with Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical attachment level (time frame: 3 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2017.