---
title: Efficacy of a Probiotic Lozenges in Chronic Periodontitis Patients.
nct_id: NCT02121665
overall_status: COMPLETED
phase: PHASE3
sponsor: CD Pharma India Pvt. Ltd.
study_type: INTERVENTIONAL
primary_condition: Chronic Periodontitis
countries: India
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02121665.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02121665"
ct_last_update_post_date: 2016-07-27
last_seen_at: "2026-05-12T06:31:46.584Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy of a Probiotic Lozenges in Chronic Periodontitis Patients.

**Official Title:** 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.

**NCT ID:** [NCT02121665](https://clinicaltrials.gov/study/NCT02121665)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 42
- **Lead Sponsor:** CD Pharma India Pvt. Ltd.
- **Collaborators:** Government Dental College and Hospital, India
- **Conditions:** Chronic Periodontitis
- **Start Date:** 2014-07
- **Completion Date:** 2016-03
- **CT.gov Last Update:** 2016-07-27

## 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.

## Eligibility

- **Minimum age:** 25 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Probiotic (Inersan) Arm** (EXPERIMENTAL) — 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
- **Placebo Arm** (PLACEBO_COMPARATOR) — 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)

## Interventions

- **Probiotic (Inersan)** (DRUG) — Each Inersan lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2
- **Placebo** (DRUG) — Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)

## Primary Outcomes

- **Improvement in Periodontal Clinical indices** _(time frame: 6 weeks)_ — Improvement in periodontal clinical indices, namely, Gingival Index (GI), Plaque Index (PI), Probing Pocket Depth (PPD) and Clinical attachment Loss (CAL).

## Secondary Outcomes

- **Improvement in biochemical indices** _(time frame: 6 weeks)_

## Locations (1)

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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.department of periodontics, government dental college & hospital|aurangabad|maharashtra|india` — added _(2026-05-12)_

---

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