Efficacy of a Probiotic Lozenges in Chronic Periodontitis Patients.

Effect of Probiotic Lozenges as an Adjunct to Non Surgical Periodontal Therapy in Chronic Periodontitis Patients: A Randomized Double Blind Placebo Controlled Clinical and Biochemical Study.

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Drug: Placebo; Drug: Probiotic (Inersan)

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Aurangabad, Maharashtra, India, 415570
      • Department of Periodontics, Government Dental College & Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic (Inersan) Arm; 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	Drug: Probiotic (Inersan); Each Inersan lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2
Placebo Comparator: Placebo Arm; 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)	Drug: Placebo; Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Periodontal Clinical indices	Improvement in periodontal clinical indices, namely, Gingival Index (GI), Plaque Index (PI), Probing Pocket Depth (PPD) and Clinical attachment Loss (CAL).	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in biochemical indices	Changes in level of inflammatory markers namely PGE2, IL-1beta, TNF-alpha, receptor activator of nuclear factor kappa B ligand (RANKL), Osteoprotegerin (OPG), MMP-9 and MMP-13 in saliva sample	6 weeks

Collaborators and Investigators

• Sponsor: CD Pharma India Pvt. Ltd.
• Collaborators: Government Dental College and Hospital, India
• Investigators: Principal Investigator: Rohan Sethi, BDS, Government Dental College & Hospital, Aurangabad

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: April 22, 2014
• First Submitted That Met QC Criteria: April 22, 2014
• First Posted (Estimate): April 23, 2014

Study Record Updates

• Last Update Posted (Estimate): July 27, 2016
• Last Update Submitted That Met QC Criteria: July 26, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: PLOZ/PG/PERIO/2013