Efficacy of a Probiotic Lozenge (Inersan) in Patients With Chronic Periodontitis

NCT01870362 | Completed Phase 3

• 1 other identifier: prob-gracetpaul_01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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 \[SRP\].

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• Improvement in periodontal indices

  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

  6 weeks, 12 weeks

Secondary Outcomes (1)

• Microbiological indices

  6 weeks, 12 weeks

Study Arms (2)

Probiotic (Inersan) Arm

EXPERIMENTAL

Inersan Lozenges (2 Lozenges bid). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2

Drug: Probiotic (Inersan)

Placebo Arm

PLACEBO COMPARATOR

Placebo Lozenges (2 lozenges bid). Placebo lozenge contains only excipients (without probiotic).

Drug: Placebo

Interventions

Probiotic (Inersan) DRUG

Also known as: Inersan contains not less than 1 billion CFU of Lactobacillus brevis CD2

Probiotic (Inersan) Arm

Placebo DRUG

Also known as: Placebo contains all excipients except the active constituent (Lactobacillus brevis CD2)

Placebo Arm

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects of both sexes
• Patients in the age group of 25-60 years
• Subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths 5-7mm in \> 30 % of the probing sites
• The subjects should have at least 16 remaining natural teeth (minimum of at least 4 teeth per quadrant)
• Subjects in good general health

You may not qualify if:

• No antibiotic therapy in the past 2 months
• Medically compromised patients
• Subjects who are pregnant/ lactating
• Smokers and/or alcoholics.
• Those who had undergone any dental surgical or non-surgical therapy within 6 months prior to the start of the study.

Sponsors & Collaborators

• CD Pharma India Pvt. Ltd.: lead
• Mahatma Gandhi Post-Graduate Institute of Dental Sciences: collaborator

Study Sites (1)

Mahatma Gandhi Post Graduate Institute of Dental Sciences (MGPGI)

Puducherry, Puducherry, 605006, India

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Grace T Paul, MBBS, MDS

  Mahatma Gandhi Post- Graduate Institute of Dental Sciences, Pondicherry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2013
• First Posted: June 6, 2013
• Study Start: June 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 23, 2014

Record last verified: 2014-07

Locations

IN (1)