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

Phase 3

Completed

• Conditions: Chronic Periodontitis
• Interventions: Drug: Lactobacillus brevis CD2 Lozenges

• Registration Number: NCT02329353
• Lead Sponsor: Next Gen Pharma India Pvt. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-29
• Study First Submitted QC: 2014-12-29
• Study First Posted: 2014-12-31
• Study Start: 2015-02
• Primary Completion: 2016-11
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-09
• Last Update Posted: 2017-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smoker group	Lactobacillus brevis CD2 Lozenges	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
Non-smoker	Lactobacillus brevis CD2 Lozenges	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in microbiological indices	8 weeks	Porphyromonas gingivalis, Tanerella forsythus

Trial Locations

Locations (1)

Krishnadevaraya College of Dental Sciences and Hospital; 🇮🇳 Bangalore, Karnataka, India