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Efficacy of a Probiotic Lozenges in Chronic Periodontitis Patients.

NCT02121665 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2016-07-27

No results posted yet for this study

Summary

Periodontal disease is an infectious disease resulting in inflammation within supporting tissues of the teeth, progressive attachment loss, and bone loss. Epidemiological studies reveal that about 10% of the adult population suffer from severe periodontitis.It comprises of two distinct but interconnected etiologic components: the periodontopathic bacteria adjacent to the periodontal tissues, and the host-mediated connective tissue-destructive responses to the causative bacteria and their metabolic products. In the arena of periodontics, the probiotics pose a great potential of plaque modification, halitosis management, altering anaerobic bacteria colonization, improvement of pocket depth, and clinical attachment gain.

Aim of the study is to analyze the beneficial effect of probiotic lozenges as an adjunct to Scaling and Root Planing, on clinical and biochemical parameters.

Conditions

  • Chronic Periodontitis

Interventions

DRUG

Probiotic (Inersan)

Each Inersan lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2

DRUG

Placebo

Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)

Sponsors & Collaborators

  • Government Dental College and Hospital, India

    collaborator OTHER_GOV

  • CD Pharma India Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Rohan Sethi, BDS · Government Dental College & Hospital, Aurangabad

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-01-31
Completion
2016-03-31

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02121665 on ClinicalTrials.gov