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

NCT ID: NCT02880397

Last Updated: 2017-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-01-31

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.

Conditions

Generalized Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Garcinia mangostana

Intervention Type: DRUG

The properties of mangostana includes antibacterial, antifungal, anti-inflammatory, anti-microbial, antioxidant, anticancer, anti-proliferative, pro-apoptotic, aromatase inhibitory properties

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.

Group Type: PLACEBO_COMPARATOR

Placebo gel

Intervention Type: DRUG

The properties of placebo includes antibacterial, antifungal, anti-inflammatory, anti-microbial, antioxidant, anticancer, anti-proliferative, pro-apoptotic, aromatase inhibitory properties

Interventions

Garcinia mangostana

The properties of mangostana includes antibacterial, antifungal, anti-inflammatory, anti-microbial, antioxidant, anticancer, anti-proliferative, pro-apoptotic, aromatase inhibitory properties

Intervention Type: DRUG

Placebo gel

The properties of placebo includes antibacterial, antifungal, anti-inflammatory, anti-microbial, antioxidant, anticancer, anti-proliferative, pro-apoptotic, aromatase inhibitory properties

Intervention Type: DRUG

Other Intervention Names

Mangosteen; Placebo

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meenakshi Ammal Dental College and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr.Jaideep Mahendra

Dr. Jaideep Mahendra

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jaideep Mahendra

Role: PRINCIPAL_INVESTIGATOR

Meenakshi Ammal Dental College and Hospital

References

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.

Reference Type: RESULT

PMID: 8841165 (View on PubMed)

Shankaranarayan D, Gopalakrishnan C, Kameswaran L. Pharmacological profile of mangostin and its derivatives. Arch Int Pharmacodyn Ther. 1979 Jun;239(2):257-69.

Reference Type: RESULT

PMID: 314790 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19186342 (View on PubMed)

Other Identifiers

MAHER - REG 2214001

Identifier Type: -

Identifier Source: org_study_id