Efficacy of a Probiotic Lozenge (Inersan) in Patients With Chronic Periodontitis

CD Pharma

Status and phase: Completed; Phase 3

Conditions: Chronic Periodontitis

Treatments: Drug: Placebo; Drug: Probiotic (Inersan)

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01870362

prob-gracetpaul_01

Details and patient eligibility

About

Periodontal disease is a major cause of tooth loss in humans and is one of the most prevalent diseases associated with bone loss. Following bacterial colonization, the gingiva becomes inflamed leading, in some cases, to the destruction of the alveolar bone. Periodontitis has two distinct but interconnected etiologic components, periodontopathic bacteria and host-mediated connective tissue-destructive responses to the causative bacteria and their metabolic products.

A few studies have revealed that probiotic Lactobacillus strains were useful in reducing gingival inflammation and the number of black-pigmented rods, including Porphyromonas gingivalis (Pg), in the saliva and sub-gingival plaque. Concerning periodontal conditions, its shown that application of beneficial bacteria, as an adjunct to scaling and root planing (SRP), can inhibit re-colonization of pathogens in periodontal pockets and reduce bleeding on probing.

The aim of the present study is to evaluate the improvement of periodontal health with probiotic (Inersan) lozenges, used as an adjunct to scaling and root planing [SRP].

Enrollment: 28 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects of both sexes
• Patients in the age group of 25-60 years
• Subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths 5-7mm in > 30 % of the probing sites
• The subjects should have at least 16 remaining natural teeth (minimum of at least 4 teeth per quadrant)
• Subjects in good general health

Exclusion criteria

• No antibiotic therapy in the past 2 months
• Medically compromised patients
• Subjects who are pregnant/ lactating
• Smokers and/or alcoholics.
• Those who had undergone any dental surgical or non-surgical therapy within 6 months prior to the start of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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28 participants in 2 patient groups, including a placebo group

Probiotic (Inersan) Arm

Experimental group

Description:

Inersan Lozenges (2 Lozenges bid). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2

Treatment:

Drug: Probiotic (Inersan)

Placebo Arm

Placebo Comparator group

Description:

Placebo Lozenges (2 lozenges bid). Placebo lozenge contains only excipients (without probiotic).

Treatment:

Drug: Placebo