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

Primary Purpose

Generalized Chronic Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Garcinia mangostana
Placebo gel
Sponsored by
Meenakshi Ammal Dental College and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Chronic Periodontitis focused on measuring Anti-inflammatory agents, antimicrobials, Periodontitis

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Garcinia Mangostana

    Placebo gel

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Clinical efficacy of 4% mangostana in chronic periodontitis patients from baseline to 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

    Microbiological efficacy of 4% mangostana in chronic periodontitis patients from baseline to 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'.

    Full Information

    First Posted
    August 11, 2016
    Last Updated
    August 29, 2017
    Sponsor
    Meenakshi Ammal Dental College and Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02880397
    Brief Title
    Garcinia Mangostana L.Pericarp Gel as a Local Drug Delivery in Treatment of Chronic Periodontitis
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Meenakshi Ammal Dental College and Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Generalized Chronic Periodontitis
    Keywords
    Anti-inflammatory agents, antimicrobials, Periodontitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Garcinia Mangostana
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Placebo gel
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Garcinia mangostana
    Other Intervention Name(s)
    Mangosteen
    Intervention Description
    The properties of mangostana includes antibacterial, antifungal, anti-inflammatory, anti-microbial, antioxidant, anticancer, anti-proliferative, pro-apoptotic, aromatase inhibitory properties
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo gel
    Other Intervention Name(s)
    Placebo
    Intervention Description
    The properties of placebo includes antibacterial, antifungal, anti-inflammatory, anti-microbial, antioxidant, anticancer, anti-proliferative, pro-apoptotic, aromatase inhibitory properties
    Primary Outcome Measure Information:
    Title
    Clinical efficacy of 4% mangostana in chronic periodontitis patients from baseline to 3 months.
    Description
    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.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Microbiological efficacy of 4% mangostana in chronic periodontitis patients from baseline to 3 months.
    Description
    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'.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jaideep Mahendra
    Organizational Affiliation
    Meenakshi Ammal Dental College and Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    8841165
    Citation
    Steinmetz KA, Potter JD. Vegetables, fruit, and cancer prevention: a review. J Am Diet Assoc. 1996 Oct;96(10):1027-39. doi: 10.1016/S0002-8223(96)00273-8.
    Results Reference
    result
    PubMed Identifier
    314790
    Citation
    Shankaranarayan D, Gopalakrishnan C, Kameswaran L. Pharmacological profile of mangostin and its derivatives. Arch Int Pharmacodyn Ther. 1979 Jun;239(2):257-69.
    Results Reference
    result
    PubMed Identifier
    19186342
    Citation
    Rassameemasmaung S, Sirikulsathean A, Amornchat C, Maungmingsook P, Rojanapanthu P, Gritsanaphan W. Topical application of Garcinia mangostana L. pericarp gel as an adjunct to periodontal treatment. Complement Ther Med. 2008 Oct;16(5):262-7. doi: 10.1016/j.ctim.2007.12.004.
    Results Reference
    result

    Learn more about this trial

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

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