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OpenTrials
Completed

NCT Number: NCT02203812

Effect of Probiotic Lozenge on Gingivitis and Periodontitis

The oral cavity is mostly influenced by general health. The oral microbiota which is as complex as the gastro-intestinal or vaginal microbiota are considered to be difficult therapeutic targets. The effects of probiotics in different fields of health care have resulted recently in the introduction of probiotics for oral healthcare. Probiotics have been clinically proved effective in different fields of oral healthcare such as halitosis, oral candidiasis and tooth decay. They have also been inducted in the field of periodontal healthcare because of the current views on the etiology of plaque- related periodontal inflammation.

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Key information

Conditions

Mild and Moderate Chronic Periodontitis Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Periodontology, Government Dental College & Hospital

Vijayawada, Andhra Pradesh, 520004, India

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with chronic mild to moderate periodontitis.
  • Having Pocket depth > 4mm.
  • Mean loss of attachment, evaluated by measuring the distance from cement-enamel junction to the bottom of the probing pocket > 4mm

Exclusion criteria

  • Patients on probiotic supplements
  • Patients who have allergy to lactose and fermented milk products
  • Smokers
  • Patients who are on antibiotic therapy or were on antibiotic therapy in the past 6 months
  • Patients with advanced periodontal and/or periapical conditions which necessitate immediate treatment
  • Patient suffering from any systemic illness
  • Patients who are deemed to be un-cooperative

Treatment and study plan

Probiotic Arm

Drug

Each Inersan lozenge contains at least 1 billion colony forming unit of Lactobacillus brevis CD2

Placebo arm

Drug

Placebo lozenges contain all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2)

Primary outcomes

  1. Improvement in Clinical Periodontal Indices

    Time frame: 8 weeks

    Improvement in clinical periodontal indices, namely, Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD), Bleeding on Probing (BOP)

Secondary outcomes

  1. Improvement in Biochemical Indices

    Time frame: 8 weeks

    Changes in levels of Inflammatory markers, namely, Interleukin 1β, Matrix metalloproteinases-8 (MMP), Myeloperoxidase (MPO) and Calprotectin in Gingival Crevicular Fluid (GCF)

Sponsors and collaborators

Lead sponsor

CD Pharma India Pvt. Ltd.

Industry

Collaborators

  • Government Dental College and Hospital, Vijayawada, Andra Pradesh, India

Registry information

Official study title

The Effect of Probiotic Lozenge Administration on Gingivitis and on Mild & Moderate Periodontitis: A Randomized Controlled Clinical Trial.

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 30, 2014
Registry last updated
Jul 27, 2016

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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