Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients

NCT ID: NCT02390687

Last Updated: 2017-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-12-31

Brief Summary

Periodontitis is an infectious inflammatory disease. Bacteria modulate the inflammatory response and alter the diversity of periodontal disease. In recent years, various host-response modulation therapies have been developed to block the pathways responsible for periodontal tissue breakdown.

There have been significant changes with respect to the effectiveness of, and attitudes towards conventional antimicrobial therapy to combat disease. With the threat of widespread antibiotic resistance rendering many antibiotics useless against important diseases, there is an increased necessity not only to minimise antibiotic use and develop novel non-antibiotic-based treatments, but also to raise the profile of disease prevention. One approach that has gained interest over recent years is the use of probiotic bacteria for oral applications. The rationale for their use in oral health care stems from the increase in evidence that supports their claims for benefit for a range of diseases. Lactobacilli play an important role in the maintenance of health by stimulating the natural immunity as well as by contributing to the balance of the microflora, by interacting with the other members of the flora. The application of health promoting bacteria for therapeutic purposes, is one of the strongest emerging fields. Time has come to shift the paradigm of the treatment from specific bacteria elimination to alteration of the bacterial ecology by using probiotics.

So the purpose of this study is to discover a more promising approach for the treatment of chronic periodontitis .

Conditions

Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo Arm

Placebo Lozenges (3 Lozenges per day; 1 lozenge in morning and 2 lozenges in the night). Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Probiotic Arm

L. brevis CD2 Lozenges (3 Lozenges per day; 1 lozenge in morning and 2 lozenges in the night). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DRUG

Each probiotic lozenge contains not less than 1 billion colony forming unit of Lactobacillus brevis CD2

Interventions

Probiotic

Each probiotic lozenge contains not less than 1 billion colony forming unit of Lactobacillus brevis CD2

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

L. brevis CD2 Lozenges

Eligibility Criteria

Inclusion Criteria

• Clinically diagnosed chronic generalized periodontitis
• Need of phase 1 therapy
• Pocket probing depth (PPD) of ≥ 5 mm < 7 mm at two and/or more sites
• Patients with no history of allergies to the drugs to be used

Exclusion Criteria

• Patients on antibiotics within 3 month prior to study
• Patients with any systemic diseases
• Patients with history of any periodontal therapy within 6 months to trial

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KVG Medical College and Hospital

OTHER

Sponsor Role: collaborator

Next Gen Pharma India Pvt. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mudnoor M Dayakar, MDS

Role: PRINCIPAL_INVESTIGATOR

KVG Medical College & Hospital

Locations

Department of Periodontics, K.V.G. College & Hospital,

Kurunjibhag, Sullia (d.k.), Karnataka, India

Countries

India

Other Identifiers

SUL_PERIO-RG_01

Identifier Type: -

Identifier Source: org_study_id