Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients

Phase 3

Completed

• Conditions: Chronic Periodontitis
• Interventions: Drug: Placebo; Drug: Probiotic

• Registration Number: NCT02390687
• Lead Sponsor: Next Gen Pharma India Pvt. Ltd.

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 .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-11
• Study First Submitted QC: 2015-03-16
• Study First Posted: 2015-03-17
• Study Start: 2015-04
• Primary Completion: 2016-09
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-09
• Last Update Posted: 2017-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Arm	Placebo	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)
Probiotic Arm	Probiotic	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in bone pattern	8 weeks	Assessment of changes in bone patterns in bith group using digital radio-graphic technique

Trial Locations

Locations (1)

Department of Periodontics, K.V.G. College & Hospital,; 🇮🇳 Kurunjibhag, Sullia (D.K.), Karnataka, India