Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients

Sponsor

Next Gen Pharma India Pvt. Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02390687

Collaborator

KVG Medical College and Hospital (Other)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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 .

Condition or Disease	Intervention/Treatment	Phase
Chronic Periodontitis	Drug: Probiotic Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Change in bone pattern [8 weeks]
Assessment of changes in bone patterns in bith group using digital radio-graphic technique

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 49 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Periodontics, K.V.G. College & Hospital,	Kurunjibhag, Sullia (D.K.)	Karnataka	India	574327

Sponsors and Collaborators

Next Gen Pharma India Pvt. Ltd.
KVG Medical College and Hospital

Investigators

Principal Investigator: Mudnoor M Dayakar, MDS, KVG Medical College & Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Next Gen Pharma India Pvt. Ltd.

ClinicalTrials.gov Identifier:

NCT02390687

Other Study ID Numbers:

SUL_PERIO-RG_01

First Posted:

Mar 17, 2015

Last Update Posted:

Jan 10, 2017

Last Verified:

Jan 1, 2017

Additional relevant MeSH terms:

Periodontitis

Chronic Periodontitis

Study Results

No Results Posted as of Jan 10, 2017