Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients

Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients-A Randomized Placebo Controlled Study.

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 .

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Drug: Placebo; Drug: Probiotic

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Kurunjibhag, Sullia (D.K.), Karnataka, India, 574327
      • Department of Periodontics, K.V.G. College & Hospital,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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)	Drug: Placebo; Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)
Experimental: 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	Drug: Probiotic; Each probiotic lozenge contains not less than 1 billion colony forming unit of Lactobacillus brevis CD2; Other Names: L. brevis CD2 Lozenges

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Periodontal Clinical indices	Improvement in periodontal clinical indices, namely, Gingival Index (GI), Bleeding on probing (BOP), Probing Pocket Depth (PPD) and Clinical attachment Loss (CAL).	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in bone pattern	Assessment of changes in bone patterns in bith group using digital radio-graphic technique	8 weeks

Collaborators and Investigators

• Sponsor: Next Gen Pharma India Pvt. Ltd.
• Collaborators: KVG Medical College and Hospital
• Investigators: Principal Investigator: Mudnoor M Dayakar, MDS, KVG Medical College & Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: March 11, 2015
• First Submitted That Met QC Criteria: March 16, 2015
• First Posted (Estimate): March 17, 2015

Study Record Updates

• Last Update Posted (Estimate): January 10, 2017
• Last Update Submitted That Met QC Criteria: January 9, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: SUL_PERIO-RG_01