Efficacy of a Probiotic Lozenges in Chronic Periodontitis Patients.

Chronic Periodontitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02121665
• Other study ID #: PLOZ/PG/PERIO/2013
• Status: Completed
• Phase: Phase 3
• First received: April 22, 2014
• Last updated: July 26, 2016
• Start date: July 2014
• Est. completion date: March 2016

Study information

• Verified date: July 2016
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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

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

Locations

Country	Name	City	State
India	Department of Periodontics, Government Dental College & Hospital	Aurangabad	Maharashtra

Sponsors (2)

Lead Sponsor	Collaborator
CD Pharma India Pvt. Ltd.	Government Dental College and Hospital, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Periodontal Clinical indices	Improvement in periodontal clinical indices, namely, Gingival Index (GI), Plaque Index (PI), Probing Pocket Depth (PPD) and Clinical attachment Loss (CAL).	6 weeks	No
Secondary	Improvement in biochemical indices	Changes in level of inflammatory markers namely PGE2, IL-1beta, TNF-alpha, receptor activator of nuclear factor kappa B ligand (RANKL), Osteoprotegerin (OPG), MMP-9 and MMP-13 in saliva sample	6 weeks	No