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Effect of Probiotic Lozenge on Gingivitis and Periodontitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02203812
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : July 27, 2016
Sponsor:
Collaborator:
Government Dental College and Hospital, Vijayawada, Andra Pradesh, India
Information provided by (Responsible Party):
CD Pharma India Pvt. Ltd.

Brief Summary:
The oral cavity is mostly influenced by general health. The oral microbiota which is as complex as the gastro-intestinal or vaginal microbiota are considered to be difficult therapeutic targets. The effects of probiotics in different fields of health care have resulted recently in the introduction of probiotics for oral healthcare. Probiotics have been clinically proved effective in different fields of oral healthcare such as halitosis, oral candidiasis and tooth decay. They have also been inducted in the field of periodontal healthcare because of the current views on the etiology of plaque- related periodontal inflammation.

Condition or disease Intervention/treatment Phase
Mild and Moderate Chronic Periodontitis Drug: Probiotic Arm Drug: Placebo Arm Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Probiotic Lozenge Administration on Gingivitis and on Mild & Moderate Periodontitis: A Randomized Controlled Clinical Trial.
Study Start Date : January 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : May 2016

Arm Intervention/treatment
Experimental: Probiotic Arm
L. brevis CD2 Lozenges (4 lozenges per day - 1 lozenge in the morning, 1 lozenge in the afternoon and 2 lozenges in the night). Each lozenge contains at least 1 billion colony forming units of Lactobacillus brevis CD2.
Drug: Probiotic Arm
Each Inersan lozenge contains at least 1 billion colony forming unit of Lactobacillus brevis CD2

Placebo Comparator: Placebo Arm
Placebo lozenges (4 lozenges per day - 1 lozenge in the morning, 1 lozenge in the afternoon and 2 lozenges in the night). The placebo lozenge contains all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2).
Drug: Placebo Arm
Placebo lozenges contain all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2)




Primary Outcome Measures :
  1. Improvement in Clinical Periodontal Indices [ Time Frame: 8 weeks ]
    Improvement in clinical periodontal indices, namely, Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD), Bleeding on Probing (BOP)


Secondary Outcome Measures :
  1. Improvement in Biochemical Indices [ Time Frame: 8 weeks ]
    Changes in levels of Inflammatory markers, namely, Interleukin 1β, Matrix metalloproteinases-8 (MMP), Myeloperoxidase (MPO) and Calprotectin in Gingival Crevicular Fluid (GCF)



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Patients with chronic mild to moderate periodontitis.
  • Having Pocket depth > 4mm.
  • Mean loss of attachment, evaluated by measuring the distance from cement-enamel junction to the bottom of the probing pocket > 4mm

Exclusion Criteria:

  • Patients on probiotic supplements
  • Patients who have allergy to lactose and fermented milk products
  • Smokers
  • Patients who are on antibiotic therapy or were on antibiotic therapy in the past 6 months
  • Patients with advanced periodontal and/or periapical conditions which necessitate immediate treatment
  • Patient suffering from any systemic illness
  • Patients who are deemed to be un-cooperative

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): NCT02203812


Locations
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India
Department of Periodontology, Government Dental College & Hospital
Vijayawada, Andra Pradesh, India, 520004
Sponsors and Collaborators
CD Pharma India Pvt. Ltd.
Government Dental College and Hospital, Vijayawada, Andra Pradesh, India
Investigators
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Principal Investigator: Surya Jyotsna Kiran Kanchumurthy, BDS Government Dental College and Hospital, Vijayawada, Andhra Pradesh
Study Director: Narendra Dev Jampani, MDS Government Dental College and Hospital, Vijayawada, Andhra Pradesh
Principal Investigator: Vajra Madhuri S, MDS Government Dental College and Hospital, Vijayawada, Andhra Pradesh
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Responsible Party: CD Pharma India Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT02203812    
Other Study ID Numbers: VIJ_GIN-PRO 01
First Posted: July 30, 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
Gingivitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Gingival Diseases