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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
Sponsor:
Collaborator:
Government Dental College and Hospital, India
Information provided by (Responsible Party):
CD Pharma India Pvt. Ltd.

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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)
Drug: Placebo
Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject of both sexes
  • Age group of 25-65 years
  • Subjects with generalized moderate to severe chronic periodontitis
  • Signed informed Consent

Exclusion Criteria:

  • Any known history of systemic diseases
  • Patients already on anti-inflammatory drugs or antibiotics
  • Patients allergic to any material used in the study
  • Pregnant and lactating women
  • Periodontal therapy in past 6 months
  • Current smoker or smoker in the past

Information from the National Library of Medicine

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


Locations
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India
Department of Periodontics, Government Dental College & Hospital
Aurangabad, Maharashtra, India, 415570
Sponsors and Collaborators
CD Pharma India Pvt. Ltd.
Government Dental College and Hospital, India
Investigators
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Principal Investigator: Rohan Sethi, BDS Government Dental College & Hospital, Aurangabad

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Responsible Party: CD Pharma India Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT02121665     History of Changes
Other Study ID Numbers: PLOZ/PG/PERIO/2013
First Posted: April 23, 2014    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases