NCT02203812

The Effect of Probiotic Lozenge Administration on Gingivitis and on Mild & Moderate Periodontitis: A Randomized Controlled Clinical Trial.

Completed Phase 3 Last updated 26 July 2016

What this trial tests

Phase 3 trial testing Probiotic Arm in Mild and Moderate Chronic Periodontitis in 32 participants. Completed in 1 May 2016.

Timeline

1 January 2015

Primary endpoint
1 February 2016

1 May 2016

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	32
Start date	1 January 2015
Primary completion	1 February 2016
Estimated completion	1 May 2016
Sites	1 location across India

Drugs / interventions tested

• Probiotic Arm — full drug profile →
• Placebo Arm

Conditions studied

• Mild and Moderate Chronic Periodontitis — all drugs for Mild and Moderate Chronic Periodontitis →

Sponsor

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

Who can join

Adults 20 to 50, any sex, with Mild and Moderate 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 Clinical Periodontal Indices
  Time frame: 8 weeks
  Improvement in clinical periodontal indices, namely, Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD), Bleeding on Probing (BOP)

Sponsor's own description

The oral cavity is mostly influenced by general health. The oral microbiota which is as complex as the gastro-intestinal or vaginal microbiota are considered to be difficult therapeutic targets. The effects of probiotics in different fields of health care have resulted recently in the introduction of probiotics for oral healthcare. Probiotics have been clinically proved effective in different fields of oral healthcare such as halitosis, oral candidiasis and tooth decay. They have also been inducted in the field of periodontal healthcare because of the current views on the etiology of plaque- related periodontal inflammation.

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