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

Next Gen Pharma

Status and phase: Completed; Phase 3

Conditions: Chronic Periodontitis

Treatments: Drug: Lactobacillus brevis CD2 Lozenges

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02329353

BAN_PERIO-SOM_01

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 30 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Smoker group

Experimental group

Description:

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

Treatment:

Drug: Lactobacillus brevis CD2 Lozenges

Non-smoker

Experimental group

Description:

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

Treatment:

Drug: Lactobacillus brevis CD2 Lozenges