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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Periodontitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Smoker group

30 chronic periodontitis patients, having habit of smoking, with probing pocket depth of equal or greater than 5 mm with bleeding on probing and radio-graphic evidence of bone loss in at at least 2 sites at each quadrant will be given three probiotic lozenge per day for 8 weeks

Group Type EXPERIMENTAL

Lactobacillus brevis CD2 Lozenges

Intervention Type DRUG

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

Non-smoker

30 chronic periodontitis patients, not having habit of smoking, with probing pocket depth of equal or greater than 5 mm with bleeding on probing and radio-graphic evidence of bone loss in at at least 2 sites at each quadrant will be given three probiotic lozenge per day for 8 weeks

Group Type EXPERIMENTAL

Lactobacillus brevis CD2 Lozenges

Intervention Type DRUG

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

Interventions

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Lactobacillus brevis CD2 Lozenges

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

Intervention Type DRUG

Other Intervention Names

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Probiotics

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No