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Completed

NCT Number: NCT02329353

Effect of Probiotics on Chronic Periodontitis in Smoker and Non- Smokers

Periodontitis is one of the most common chronic inflammatory disease with the etiology of bacterial plaque and is associated with a number of putative bacterial species. The periodontal destruction is substantially mediated by the host, driven by the bacterial challenge. The presence of pathogenic bacteria with the absence of so-called "beneficial bacteria" and the susceptibility of the host are the main aetiological factors of periodontal diseases.

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Key information

Conditions

Chronic Periodontitis Chronic Disease Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Krishnadevaraya College of Dental Sciences and Hospital

Bangalore, Karnataka, 562157, India

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients free from any systemic illness
  • Previously untreated moderate to severe generalised chronic periodontitis.
  • Patients free from adverse reactions to lactose or fermented milk products
  • Patient unwilling to quit smoking and smokers over the past one year ( Smoker arm).

Exclusion criteria

  • Previous history of antibiotic usage over past 6 months
  • Patients who are eligible for antibiotic usage during the treatment course
  • Patients who are pregnant, lactating, alcoholic or who had undergone any surgical or nonsurgical therapy within 6 months.
  • Acute oral lesions or necrotising ulcerative periodontitis

Treatment and study plan

Lactobacillus brevis CD2 Lozenges

Drug

Each lozenge contains not less than 1 billion Colony forming unit of Lactobacillus brevis CD2

Other names: Probiotics

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)

Secondary outcomes

  1. Change in microbiological indices

    Time frame: 8 weeks

    Porphyromonas gingivalis, Tanerella forsythus

Sponsors and collaborators

Lead sponsor

Next Gen Pharma India Pvt. Ltd.

Industry

Collaborators

  • Krishnadevaraya College of Dental Sciences & Hospital

Registry information

Official study title

Clinical And Microbiological Analysis Of Orally Administered Lactobacillus Probiotic Lozenges In Chronic Periodontitis Patients Among Smokers And Non-smokers And Its Correlation With Clinical Parameters - A Clinico-Microbiological Study

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 31, 2014
Registry last updated
Jan 10, 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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