Efficacy of a Probiotic Lozenges in Chronic Periodontitis Patients.

NCT02121665 | Completed Phase 3

• 1 other identifier: PLOZ/PG/PERIO/2013
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Improvement in biochemical indices

  6 weeks

Study Arms (2)

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

Drug: Probiotic (Inersan)

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)

Drug: Placebo

Interventions

Probiotic (Inersan) DRUG

Each Inersan lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2

Probiotic (Inersan) Arm

Placebo DRUG

Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)

Placebo Arm

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject of both sexes
• Age group of 25-65 years
• Subjects with generalized moderate to severe chronic periodontitis
• Signed informed Consent

You may not qualify if:

• 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

Sponsors & Collaborators

• CD Pharma India Pvt. Ltd.: lead
• Government Dental College and Hospital, India: collaborator

Study Sites (1)

Department of Periodontics, Government Dental College & Hospital

Aurangabad, Maharashtra, 415570, 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

• Rohan Sethi, BDS

  Government Dental College & Hospital, Aurangabad

  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: April 22, 2014
• First Posted: April 23, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 27, 2016

Record last verified: 2016-07

Locations

IN (1)