Efficacy of a Probiotic Lozenges in Chronic Periodontitis Patients.

Phase 3

Completed

• Conditions: Chronic Periodontitis
• Interventions: Drug: Placebo; Drug: Probiotic (Inersan)

• Registration Number: NCT02121665
• Lead Sponsor: CD Pharma India Pvt. Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-22
• Study First Submitted QC: 2014-04-22
• Study First Posted: 2014-04-23
• Study Start: 2014-07
• Primary Completion: 2016-01
• Study Completion: 2016-03
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-26
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Arm	Placebo	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)
Probiotic (Inersan) Arm	Probiotic (Inersan)	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Improvement in biochemical indices	6 weeks	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

Trial Locations

Locations (1)

Department of Periodontics, Government Dental College & Hospital; 🇮🇳 Aurangabad, Maharashtra, India