Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-02-27 @ 2:21 PM
Study NCT ID:
NCT02174757
Status:
COMPLETED
Last Update Posted:
2014-12-15
First Post:
2014-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Probiotic Inersan and Doxycycline in Chronic Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055113', 'term': 'Chronic Periodontitis'}], 'ancestors': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004318', 'term': 'Doxycycline'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-12', 'studyFirstSubmitDate': '2014-06-19', 'studyFirstSubmitQcDate': '2014-06-24', 'lastUpdatePostDateStruct': {'date': '2014-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in periodontal clinical indices', 'timeFrame': '4 weeks', 'description': 'Improvement in periodontal clinical indices, namely, Gingival Index (GI), Probing Pocket Depth (PPD), Plaque Index (PI) and Clinical Attachment level (CAL)'}], 'secondaryOutcomes': [{'measure': 'Improvement in microbiological indices', 'timeFrame': '4 weeks', 'description': 'Changes in salivary count of Lactobacilli and Porphyromonas gingivalis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Periodontitis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects in both sexes\n2. Age 25 - 60 yrs\n3. Subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths ≥ 5mm in \\> 30 % of the probing sites\n4. Subjects in good general health\n\nExclusion Criteria:\n\n1. Antibiotic therapy in the past 2 months\n2. Allergic to doxycycline or probiotics\n3. Subjects with diabetic mellitus, hypertension and psychiatric disorders\n4. Subjects who are pregnant/ lactating\n5. Smokers and/or alcoholics\n6. Subjects who have undergone any periodontal therapy within last 6 months.'}, 'identificationModule': {'nctId': 'NCT02174757', 'briefTitle': 'Effect of Probiotic Inersan and Doxycycline in Chronic Periodontitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'CD Pharma India Pvt. Ltd.'}, 'officialTitle': 'A Comparative Evaluation of the Effect of Probiotic Inersan and Doxycycline on Chronic Periodontitis - A Clinical and Microbiological Study', 'orgStudyIdInfo': {'id': 'KUL_SMIDS_PERIO_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inersan', '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.', 'interventionNames': ['Drug: Inersan']}, {'type': 'EXPERIMENTAL', 'label': 'Inersan and Doxycycline together', 'description': 'Doxycycline: 1 Tablet once daily (in afternoon) for 2 weeks. Each tablet contains 100 mg Doxycycline.\n\nInersan - 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.', 'interventionNames': ['Drug: Inersan', 'Drug: Doxycycline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Doxycycline', 'description': 'Doxycycline: 1 Tablet once daily (in afternoon) for 2 weeks. Each tablet contains 100 mg Doxycycline.', 'interventionNames': ['Drug: Doxycycline']}], 'interventions': [{'name': 'Inersan', 'type': 'DRUG', 'otherNames': ['Each lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2'], 'description': 'Probiotic', 'armGroupLabels': ['Inersan', 'Inersan and Doxycycline together']}, {'name': 'Doxycycline', 'type': 'DRUG', 'otherNames': ['Each tablet contains 100 mg of Doxycycline'], 'description': 'Antibiotic', 'armGroupLabels': ['Doxycycline', 'Inersan and Doxycycline together']}]}, 'contactsLocationsModule': {'locations': [{'zip': '629161', 'city': 'Kulasegaram', 'state': 'Tamil Naidu', 'country': 'India', 'facility': 'Dept. of Periodontics and Implantology, Sree Mookambika Institute of Dental Sciences', 'geoPoint': {'lat': 8.36319, 'lon': 77.29777}}], 'overallOfficials': [{'name': 'Arya K.S., BDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sree Mookambika Institute of Dental Sciences'}, {'name': 'Elizabeth Koshi, MDS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sree Mookambika Institute of Dental Sciences'}, {'name': 'Arun Sadasivan, MDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sree Mookambika Institute of Dental Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CD Pharma India Pvt. Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sree Mookambika Institute of Dental Sciences', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}