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

Meenakshi Ammal Dental College and Hospital

Status: Completed

Conditions: Generalized Chronic Periodontitis

Treatments: Drug: Placebo gel; Drug: Garcinia mangostana

Study type: Interventional

Funder types: Other

Identifiers

NCT02880397

MAHER - REG 2214001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Garcinia Mangostana

Active Comparator group

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.

Treatment:

Drug: Garcinia mangostana

Placebo gel

Placebo Comparator group

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.

Treatment:

Drug: Placebo gel