NCT01870362

Improvement of Periodontal Health and Reduction in Periodontal Plaque Micro-flora Using a Probiotic Lozenge in Patients With Chronic Periodontitis

Completed Phase 3 Last updated 22 July 2014

What this trial tests

Phase 3 trial testing Probiotic (Inersan) in Chronic Periodontitis in 28 participants. Completed in 1 July 2014.

Timeline

1 June 2013

Primary endpoint
1 July 2014

1 July 2014

Quick facts

Lead sponsor	CD Pharma India Pvt. Ltd.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	28
Start date	1 June 2013
Primary completion	1 July 2014
Estimated completion	1 July 2014
Sites	1 location across India

Drugs / interventions tested

• Probiotic (Inersan) — full drug profile →
• Placebo

Conditions studied

• Chronic Periodontitis — all drugs for Chronic Periodontitis →

Sponsor

CD Pharma India Pvt. Ltd. — full company profile →

Who can join

Adults 25 to 60, any sex, with Chronic Periodontitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Improvement in periodontal indices
  Time frame: 6 weeks, 12 weeks
  Improvement in Periodontal indices, namely, plaque index \[PI\], Gingival index \[GI\], Gingival bleeding index \[GBI\], probing pocket depth \[PPD\] and clinical attachment levels \[CAL\] in both groups

Sponsor's own description

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 \[SRP\].

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Recent advances in therapeutic probiotics: insights from human trials.
   Cho M-Y, Eom J-H, Choi E-M, Yang S-J, et al · · 2025 · cited 17× · PMID 40261032 · DOI 10.1128/cmr.00240-24