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

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.

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Key information

Conditions

Generalized Chronic Periodontitis Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Garcinia mangostana

Drug

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

Other names: Mangosteen

Placebo Gel

Drug

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

Other names: Placebo

Primary outcomes

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 outcomes

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'.

Sponsors and collaborators

Lead sponsor

Meenakshi Ammal Dental College and Hospital

Other

Registry information

Official study 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

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2016
First posted: Aug 26, 2016
Registry last updated: Aug 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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