Efficacy of a Probiotic Lozenges in Chronic Periodontitis Patients.

CD Pharma

Status and phase: Completed; Phase 3

Conditions: Chronic Periodontitis

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02121665

PLOZ/PG/PERIO/2013

Details and patient eligibility

About

Periodontal disease is an infectious disease resulting in inflammation within supporting tissues of the teeth, progressive attachment loss, and bone loss. Epidemiological studies reveal that about 10% of the adult population suffer from severe periodontitis.It comprises of two distinct but interconnected etiologic components: the periodontopathic bacteria adjacent to the periodontal tissues, and the host-mediated connective tissue-destructive responses to the causative bacteria and their metabolic products. In the arena of periodontics, the probiotics pose a great potential of plaque modification, halitosis management, altering anaerobic bacteria colonization, improvement of pocket depth, and clinical attachment gain.

Aim of the study is to analyze the beneficial effect of probiotic lozenges as an adjunct to Scaling and Root Planing, on clinical and biochemical parameters.

Enrollment: 42 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject of both sexes
• Age group of 25-65 years
• Subjects with generalized moderate to severe chronic periodontitis
• Signed informed Consent

Exclusion criteria

• Any known history of systemic diseases
• Patients already on anti-inflammatory drugs or antibiotics
• Patients allergic to any material used in the study
• Pregnant and lactating women
• Periodontal therapy in past 6 months
• Current smoker or smoker in the past

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups, including a placebo group

Probiotic (Inersan) Arm

Experimental group

Description:

Inersan Lozenges (4 Lozenges per day; 1 lozenge in morning,1 lozenge in the afternoon and 2 lozenges in the night). 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 (4 Lozenges per day; 1 lozenge in morning,1 lozenge in the afternoon and 2 lozenges in the night). Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)

Treatment:

Drug: Placebo