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CompletedNCT02329353Updated Jan 10, 2017

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

A Phase 3 interventional study of Lactobacillus brevis CD2 Lozenges in Chronic Periodontitis, sponsored by Next Gen Pharma India Pvt. Ltd.. Completed at 1 site in India. Open to participants aged 30 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-01-10.

Sponsored by Next Gen Pharma India Pvt. Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
30 Years to 55 Years
Sex
All
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Study 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.

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Conditions studied

  • Chronic Periodontitis

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03

In context

Chronic Periodontitis

386 studies on the registry are indexed under Chronic Periodontitis; 23 are open to participants now.

This study's enrollment of 60 is above the median of 46 across 314 interventional studies indexed under Chronic Periodontitis.

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Lead sponsor

Next Gen Pharma India Pvt. Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    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

    Drug: Lactobacillus brevis CD2 Lozenges

  • Experimental
    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

    Drug: Lactobacillus brevis CD2 Lozenges

Interventions

  • DrugLactobacillus brevis CD2 Lozenges

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

    Also known as: Probiotics

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What researchers measure

Primary outcomes

  1. Improvement in Clinical Periodontal Indices

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

    Time frame: 8 weeks

Secondary outcomes

  1. Change in microbiological indices

    Porphyromonas gingivalis, Tanerella forsythus

    Time frame: 8 weeks

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Study locations

1 site
  • Krishnadevaraya College of Dental Sciences and Hospital
    Bangalore, Karnataka 562157, India
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02329353
Lead sponsor
Next Gen Pharma India Pvt. Ltd.
Collaborators
Krishnadevaraya College of Dental Sciences & Hospital
Responsible party
Sponsor
First posted
Dec 31, 2014
Start date
Feb 2015
Primary completion
Nov 2016
Completion
Dec 2016
Last update
Jan 10, 2017

Study contacts

Rudrakshi chickanna, MDS
principal investigator · KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL, BANGALORE
Shruthi J R, BDS
principal investigator · KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL, BANGALORE
Prabhuji MLV, MDS
principal investigator · KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL, BANGALORE

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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