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

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01870362
• Other study ID #: prob-gracetpaul_01
• Status: Completed
• Phase: Phase 3
• First received: June 3, 2013
• Last updated: July 22, 2014
• Start date: June 2013
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: CD Pharma India Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• Probiotic (Inersan)

• Placebo

Locations

Country	Name	City	State
India	Mahatma Gandhi Post Graduate Institute of Dental Sciences (MGPGI)	Puducherry

Sponsors (2)

Lead Sponsor	Collaborator
CD Pharma India Pvt. Ltd.	Mahatma Gandhi Post-Graduate Institute of Dental Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Microbiological indices	Changes in pathogen (Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), and Prevotella intermedia) levels	6 weeks, 12 weeks	No