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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02329353

Enrollment

Registered

2014-12-31

Start date

2015-02-28

Completion date

2016-12-31

Last updated

2017-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periodontitis

Brief summary

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.

Interventions

DRUGLactobacillus brevis CD2 Lozenges

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Improvement in Clinical Periodontal Indices	8 weeks	Improvement in clinical periodontal indices, namely, Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD)

Secondary

Measure	Time frame	Description
Change in microbiological indices	8 weeks	Porphyromonas gingivalis, Tanerella forsythus

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026