Garcinia Mangostana L.Pericarp Gel as a Local Drug Delivery in Treatment of Chronic Periodontitis

August 29, 2017 updated by: Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital

Clinical And Microbiological Efficacy Of 4% Garcinia Mangostana L.Pericarp Gel As A Local Drug Delivery In The Treatment Of Chronic Periodontitis: A Randomized Controlled Clinical Trial

A single-center, randomized controlled clinical trial was done to assess the periodontal status of the individuals and the presence of red complex microorganisms (RCM) such as Treponema denticola, Porphyromonas.gingivalis and Tannerella.forsythia in the subgingival tissues of periodontal pockets at baseline followed by the application of mangostana gel as an adjunct to scaling and root planing. The periodontal parameters and RCM were again assessed at 3rd month and compared with the placebo group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: The study aim to assess the periodontal status of individuals and the presence of red complex microorganisms (RCM) such as Treponema denticola (T.d), Porphyromonas gingivalis (P.g) and Tannerella forsythia (T.f) in the subgingival tissues of periodontitis subjects before and after the application of 4% mangostana gel (MGA) as an adjunct to scaling and root planing.

Methods: 25 sextants (MGA group) were treated with scaling and root planing (SRP) and subgingival application of mangostana gel used as local drug delivery (LDD). 25 sextants (Placebo group) were treated with SRP and placebo gel. Clinical parameters were recorded and the presence of RCM were assessed at baseline and at 3rd month.

Statistical Analysis: The mean probing pocket depth, clinical attachment level, bleeding index, plaque index were assessed at 0th day and 3rd month and compared between the groups using one way analysis of co-variance (ANCOVA). Intra-group comparison (MGA) for the presence of T.d, from baseline to 3rd month and inter-group comparison (MGA & Placebo) at 3rd month was done using Fischer exact test. In both MGA and placebo group, the presence of T.d in subgingival tissues was compared with the clinical parameters at 3rd month using student's t-test. The p ≤ 0.05 was chosen as a level of significance.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 30 to 65 years
  • Systemically healthy subjects with chronic periodontitis

Exclusion Criteria:

  • aggressive periodontitis,
  • systemic disorders,
  • known or suspected allergy to the MGA/placebo group,
  • pregnant and lactating females,
  • long term steroid medication,
  • smokers,
  • alcoholics,
  • immunocompromised individuals and
  • those with history of antibiotic or periodontal therapy in preceding 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Garcinia Mangostana
The constituents of mangostana containing gel were prepared under the following proportions: Mangostana powder - 4gm, Gelatin - 12gm, Glycerin (wetting agent) - 0.2ml, Peppermint oil (flavouring agent) - 0.1ml, sodium saccharine (sweetening agent) - 0.1ml and purified water q.s 100ml.
Drug: Garcinia mangostana
The properties of mangostana includes antibacterial, antifungal, anti-inflammatory, anti-microbial, antioxidant, anticancer, anti-proliferative, pro-apoptotic, aromatase inhibitory properties
Other Names:
  • Mangosteen
PLACEBO_COMPARATOR: Placebo gel
The placebo gel was prepared with Gelatin - 12gm, Glycerin (wetting agent) - 0.2ml, Peppermint oil (flavouring agent) - 0.1ml, sodium saccharine (sweetening agent) - 0.1ml and purified water q.s 100ml excluding the active ingredient mangostana powder - 4 mg and maintaining same physical properties such as color and taste.
Drug: Placebo gel
The properties of placebo includes antibacterial, antifungal, anti-inflammatory, anti-microbial, antioxidant, anticancer, anti-proliferative, pro-apoptotic, aromatase inhibitory properties
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical efficacy of 4% mangostana in chronic periodontitis patients from baseline to 3 months.
Time Frame: 3 months

probing pocket depth was measured using Williams periodontal probe with the measurement of 0 to 9 mm and the criteria is as follows - 2 to 4 mm for gingivitis, 4 to 5 mm for slight periodontitis, 6 to 7 mm for moderate periodontitis and > 7 mm for advanced periodontal disease.

Clinical attachment level was measured from cemento-enamel junction to the base of the pocket using Williams periodontal probe with the criteria of 1 to 2 mm for slight periodontitis, 3 to 4 mm for moderate periodontits and greater or equal to 5 mm for severe periodontitis.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Microbiological efficacy of 4% mangostana in chronic periodontitis patients from baseline to 3 months.
Time Frame: 3 months
Red complex microorganisms such as Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola were analysed using 16S rRNA gene amplification by polymerase chain reaction for their absence as '0' and presence as '1'.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Meenakshi Ammal Dental College and Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MAHER - REG 2214001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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