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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02121665

Enrollment

Registered

2014-04-23

Start date

2014-07-31

Completion date

2016-03-31

Last updated

2016-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periodontitis

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.

Interventions

DRUGProbiotic (Inersan)

Each Inersan lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2

DRUGPlacebo

Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

25 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026