Effect of Probiotic Inersan and Doxycycline in Chronic Periodontitis
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Inersan
Doxycycline
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis
Eligibility Criteria
Inclusion Criteria:
- Subjects in both sexes
- Age 25 - 60 yrs
- Subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths ≥ 5mm in > 30 % of the probing sites
- Subjects in good general health
Exclusion Criteria:
- Antibiotic therapy in the past 2 months
- Allergic to doxycycline or probiotics
- Subjects with diabetic mellitus, hypertension and psychiatric disorders
- Subjects who are pregnant/ lactating
- Smokers and/or alcoholics
- Subjects who have undergone any periodontal therapy within last 6 months.
Sites / Locations
- Dept. of Periodontics and Implantology, Sree Mookambika Institute of Dental Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Inersan
Inersan and Doxycycline together
Doxycycline
Arm Description
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.
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.
Doxycycline: 1 Tablet once daily (in afternoon) for 2 weeks. Each tablet contains 100 mg Doxycycline.
Outcomes
Primary Outcome Measures
Improvement in periodontal clinical indices
Improvement in periodontal clinical indices, namely, Gingival Index (GI), Probing Pocket Depth (PPD), Plaque Index (PI) and Clinical Attachment level (CAL)
Secondary Outcome Measures
Improvement in microbiological indices
Changes in salivary count of Lactobacilli and Porphyromonas gingivalis
Full Information
NCT ID
NCT02174757
First Posted
June 19, 2014
Last Updated
December 12, 2014
Sponsor
CD Pharma India Pvt. Ltd.
Collaborators
Sree Mookambika Institute of Dental Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02174757
Brief Title
Effect of Probiotic Inersan and Doxycycline in Chronic Periodontitis
Official Title
A Comparative Evaluation of the Effect of Probiotic Inersan and Doxycycline on Chronic Periodontitis - A Clinical and Microbiological Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CD Pharma India Pvt. Ltd.
Collaborators
Sree Mookambika Institute of Dental Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inersan
Arm Type
Experimental
Arm Description
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.
Arm Title
Inersan and Doxycycline together
Arm Type
Experimental
Arm Description
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.
Arm Title
Doxycycline
Arm Type
Active Comparator
Arm Description
Doxycycline: 1 Tablet once daily (in afternoon) for 2 weeks. Each tablet contains 100 mg Doxycycline.
Intervention Type
Drug
Intervention Name(s)
Inersan
Other Intervention Name(s)
Each lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2
Intervention Description
Probiotic
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Other Intervention Name(s)
Each tablet contains 100 mg of Doxycycline
Intervention Description
Antibiotic
Primary Outcome Measure Information:
Title
Improvement in periodontal clinical indices
Description
Improvement in periodontal clinical indices, namely, Gingival Index (GI), Probing Pocket Depth (PPD), Plaque Index (PI) and Clinical Attachment level (CAL)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Improvement in microbiological indices
Description
Changes in salivary count of Lactobacilli and Porphyromonas gingivalis
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects in both sexes
Age 25 - 60 yrs
Subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths ≥ 5mm in > 30 % of the probing sites
Subjects in good general health
Exclusion Criteria:
Antibiotic therapy in the past 2 months
Allergic to doxycycline or probiotics
Subjects with diabetic mellitus, hypertension and psychiatric disorders
Subjects who are pregnant/ lactating
Smokers and/or alcoholics
Subjects who have undergone any periodontal therapy within last 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arya K.S., BDS
Organizational Affiliation
Sree Mookambika Institute of Dental Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elizabeth Koshi, MDS
Organizational Affiliation
Sree Mookambika Institute of Dental Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Arun Sadasivan, MDS
Organizational Affiliation
Sree Mookambika Institute of Dental Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Periodontics and Implantology, Sree Mookambika Institute of Dental Sciences
City
Kulasekharam
State/Province
Tamil Naidu
ZIP/Postal Code
629161
Country
India
12. IPD Sharing Statement
Learn more about this trial
Effect of Probiotic Inersan and Doxycycline in Chronic Periodontitis
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