Efficacy of a Probiotic Lozenges in Chronic Periodontitis Patients.
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|ClinicalTrials.gov Identifier: NCT02121665|
Recruitment Status : Completed
First Posted : April 23, 2014
Last Update Posted : July 27, 2016
Periodontal disease is an infectious disease resulting in inflammation within supporting tissues of the teeth, progressive attachment loss, and bone loss. Epidemiological studies reveal that about 10% of the adult population suffer from severe periodontitis.It comprises of two distinct but interconnected etiologic components: the periodontopathic bacteria adjacent to the periodontal tissues, and the host-mediated connective tissue-destructive responses to the causative bacteria and their metabolic products. In the arena of periodontics, the probiotics pose a great potential of plaque modification, halitosis management, altering anaerobic bacteria colonization, improvement of pocket depth, and clinical attachment gain.
Aim of the study is to analyze the beneficial effect of probiotic lozenges as an adjunct to Scaling and Root Planing, on clinical and biochemical parameters.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Periodontitis||Drug: Probiotic (Inersan) Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Probiotic Lozenges as an Adjunct to Non Surgical Periodontal Therapy in Chronic Periodontitis Patients: A Randomized Double Blind Placebo Controlled Clinical and Biochemical Study.|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||March 2016|
Experimental: Probiotic (Inersan) Arm
Inersan Lozenges (4 Lozenges per day; 1 lozenge in morning,1 lozenge in the afternoon and 2 lozenges in the night). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2
Drug: Probiotic (Inersan)
Each Inersan lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2
Placebo Comparator: Placebo Arm
Placebo Lozenges (4 Lozenges per day; 1 lozenge in morning,1 lozenge in the afternoon 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)
- Improvement in Periodontal Clinical indices [ Time Frame: 6 weeks ]Improvement in periodontal clinical indices, namely, Gingival Index (GI), Plaque Index (PI), Probing Pocket Depth (PPD) and Clinical attachment Loss (CAL).
- Improvement in biochemical indices [ Time Frame: 6 weeks ]Changes in level of inflammatory markers namely PGE2, IL-1beta, TNF-alpha, receptor activator of nuclear factor kappa B ligand (RANKL), Osteoprotegerin (OPG), MMP-9 and MMP-13 in saliva sample
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): NCT02121665
|Department of Periodontics, Government Dental College & Hospital|
|Aurangabad, Maharashtra, India, 415570|
|Principal Investigator:||Rohan Sethi, BDS||Government Dental College & Hospital, Aurangabad|