Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients
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|ClinicalTrials.gov Identifier: NCT02390687|
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : January 10, 2017
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients-A Randomized Placebo Controlled Study.|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||December 2016|
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)
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
Each probiotic lozenge contains not less than 1 billion colony forming unit of Lactobacillus brevis CD2
Other Name: L. brevis CD2 Lozenges
- Improvement in Periodontal Clinical indices [ Time Frame: 8 weeks ]Improvement in periodontal clinical indices, namely, Gingival Index (GI), Bleeding on probing (BOP), Probing Pocket Depth (PPD) and Clinical attachment Loss (CAL).
- Change in bone pattern [ Time Frame: 8 weeks ]Assessment of changes in bone patterns in bith group using digital radio-graphic technique
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02390687
|Department of Periodontics, K.V.G. College & Hospital,|
|Kurunjibhag, Sullia (D.K.), Karnataka, India, 574327|
|Principal Investigator:||Mudnoor M Dayakar, MDS||KVG Medical College & Hospital|