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

NCT02880397 | Completed DMC

• 1 other identifier: MAHER - REG 2214001
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Generalized Chronic Periodontitis

Keywords

Anti-inflammatory agents, antimicrobials, Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (1)

• Microbiological efficacy of 4% mangostana in chronic periodontitis patients from baseline to 3 months.

  3 months

Study Arms (2)

Garcinia Mangostana

ACTIVE COMPARATOR

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

Placebo gel

PLACEBO COMPARATOR

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

Interventions

Garcinia mangostana DRUG

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

Also known as: Mangosteen

Garcinia Mangostana

Placebo gel DRUG

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

Also known as: Placebo

Placebo gel

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 30 to 65 years
• Systemically healthy subjects with chronic periodontitis

You may not qualify if:

• 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

Sponsors & Collaborators

• Meenakshi Ammal Dental College and Hospital: lead

Related Publications (3)

• 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.

  PMID: 8841165 RESULT

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

  PMID: 314790 RESULT

• 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.

  PMID: 19186342 RESULT

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Jaideep Mahendra

  Meenakshi Ammal Dental College and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Jaideep Mahendra

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 26, 2016
• Study Start: August 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: January 1, 2016
• Last Updated: August 30, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share