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

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ClinicalTrials.gov Identifier: NCT02880397
Recruitment Status : Completed
First Posted : August 26, 2016
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Generalized Chronic Periodontitis Drug: Garcinia mangostana Drug: Placebo gel Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : January 2016

Arm Intervention/treatment
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 Name: 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 Name: Placebo




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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'.



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02880397


Sponsors and Collaborators
Meenakshi Ammal Dental College and Hospital
Investigators
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Principal Investigator: Jaideep Mahendra Meenakshi Ammal Dental College and Hospital

Publications of Results:
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Responsible Party: Dr.Jaideep Mahendra, Dr. Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital
ClinicalTrials.gov Identifier: NCT02880397     History of Changes
Other Study ID Numbers: MAHER - REG 2214001
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital:
Anti-inflammatory agents, antimicrobials, Periodontitis

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Inflammatory Agents