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Effect of Probiotic Inersan and Doxycycline in Chronic Periodontitis

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ClinicalTrials.gov Identifier: NCT02174757
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : December 15, 2014
Sponsor:
Collaborator:
Sree Mookambika Institute of Dental Sciences
Information provided by (Responsible Party):
CD Pharma India Pvt. Ltd.

Study Description
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Brief Summary:
Periodontitis is a multifactorial disease that can lead to the destruction of supporting tissues of the teeth resulting in pocket formation, recession or both. Since the primary etiological factors for periodontal disease are bacteria in supra and sub gingival biofilm, efforts for disease prevention and treatment are mainly focused on pathogen reduction and strengthening of epithelial barrier, thus contributing to decreased susceptibility to infection. Due to emergence of antibiotic resistance and frequent recolonization of treated sites with pathogenic bacteria, there was need for a new treatment paradigm to be introduced to periodontal disease. The need was fulfilled by the introduction of Probiotics and Bacterial Replacement Therapy. The term probiotic is derived from the Greek, meaning "for life" are microorganisms proven to exert health promoting influences in humans and animals. Food and Agriculture Organization and WHO have stated that there is potential for probiotic foods to provide health benefits and that specific strains are safe for human use.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: Inersan Drug: Doxycycline Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative Evaluation of the Effect of Probiotic Inersan and Doxycycline on Chronic Periodontitis - A Clinical and Microbiological Study
Study Start Date : August 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Inersan
Inersan - 2 Lozenges daily (one lozenge in morning and one lozenge in night) for 2 weeks. Each lozenge contains at least 1 billion CFU of Lactobacillus brevis CD2.
 Drug: Inersan
Probiotic
Other Name: Each lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2
Experimental: Inersan and Doxycycline together

Doxycycline: 1 Tablet once daily (in afternoon) for 2 weeks. Each tablet contains 100 mg Doxycycline.

Inersan - 2 Lozenges daily (one lozenge in morning and one lozenge in night) for 2 weeks. Each lozenge contains at least 1 billion CFU of Lactobacillus brevis CD2.

 Drug: Inersan
Probiotic
Other Name: Each lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2

Drug: Doxycycline
Antibiotic
Other Name: Each tablet contains 100 mg of Doxycycline
Active Comparator: Doxycycline
Doxycycline: 1 Tablet once daily (in afternoon) for 2 weeks. Each tablet contains 100 mg Doxycycline.
 Drug: Doxycycline
Antibiotic
Other Name: Each tablet contains 100 mg of Doxycycline


Outcome Measures
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Primary Outcome Measures :
  1. Improvement in periodontal clinical indices [ Time Frame: 4 weeks ]
    Improvement in periodontal clinical indices, namely, Gingival Index (GI), Probing Pocket Depth (PPD), Plaque Index (PI) and Clinical Attachment level (CAL)


Secondary Outcome Measures :
  1. Improvement in microbiological indices [ Time Frame: 4 weeks ]
    Changes in salivary count of Lactobacilli and Porphyromonas gingivalis


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects in both sexes
  2. Age 25 - 60 yrs
  3. Subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths ≥ 5mm in > 30 % of the probing sites
  4. Subjects in good general health

Exclusion Criteria:

  1. Antibiotic therapy in the past 2 months
  2. Allergic to doxycycline or probiotics
  3. Subjects with diabetic mellitus, hypertension and psychiatric disorders
  4. Subjects who are pregnant/ lactating
  5. Smokers and/or alcoholics
  6. Subjects who have undergone any periodontal therapy within last 6 months.
Contacts and Locations
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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): NCT02174757


Locations
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India
Dept. of Periodontics and Implantology, Sree Mookambika Institute of Dental Sciences
Kulasekharam, Tamil Naidu, India, 629161
Sponsors and Collaborators
CD Pharma India Pvt. Ltd.
Sree Mookambika Institute of Dental Sciences
Investigators
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Principal Investigator: Arya K.S., BDS Sree Mookambika Institute of Dental Sciences
Study Director: Elizabeth Koshi, MDS Sree Mookambika Institute of Dental Sciences
Principal Investigator: Arun Sadasivan, MDS Sree Mookambika Institute of Dental Sciences
More Information
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Responsible Party: CD Pharma India Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT02174757    
Other Study ID Numbers: KUL_SMIDS_PERIO_01
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: December 15, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Doxycycline
 Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents