Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2026-02-21 @ 1:51 AM
Study NCT ID:
NCT01906450
Status:
UNKNOWN
Last Update Posted:
2013-07-24
First Post:
2013-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER HIGH SENSITIVE C-REACTIVE PROTEIN. RANDOMIZED CONTROLLED CLINICAL TRIAL.
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': 'D014080', 'term': 'Tooth Exfoliation'}, {'id': 'D016745', 'term': 'Root Planing'}, {'id': 'D017963', 'term': 'Azithromycin'}], 'ancestors': [{'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'id': 'D012534', 'term': 'Dental Scaling'}, {'id': 'D003777', 'term': 'Dental Prophylaxis'}, {'id': 'D010517', 'term': 'Periodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D013357', 'term': 'Subgingival Curettage'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}, {'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-07-19', 'studyFirstSubmitDate': '2013-05-23', 'studyFirstSubmitQcDate': '2013-07-19', 'lastUpdatePostDateStruct': {'date': '2013-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER PERIODONTAL PARAMETERS', 'timeFrame': '3 months', 'description': 'evaluate the effect of periodontal therapy alone or with azithromycin on periodontal parameters (probing deep, bleeding on probing, clinical atachment level) in patients with chronic periodontitis.'}], 'primaryOutcomes': [{'measure': 'EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER HIGH SENSITIVE C-REACTIVE PROTEIN.', 'timeFrame': '3 months', 'description': 'High sensitive C reactive protein - hs-PCR levels evaluate the effect of periodontal therapy alone or with azithromycin on levels of high sensitivity C-reactive protein (hs CRP) in patients with chronic periodontitis'}], 'secondaryOutcomes': [{'measure': 'STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER LIPIDIC PROFILE', 'timeFrame': '3 months', 'description': 'evaluate the effect of periodontal therapy alone or with azithromycin on levels of profile lipidic (Total cholesterol, triglycerides, HDL, LDL) in patients with chronic periodontitis'}, {'measure': 'STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER GLYCEMIA LEVELS', 'timeFrame': '3 months', 'description': 'evaluate the effect of periodontal therapy alone or with azithromycin on levels of glycemia in patients with chronic periodontitis'}, {'measure': 'STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER BLOOD BIOCHEMISTRY', 'timeFrame': '3 MONTHS', 'description': 'evaluate the effect of periodontal therapy alone or with azithromycin on blood biochemistry (arterial index, hemogram) in patients with chronic periodontitis.'}]}, 'conditionsModule': {'conditions': ['Chronic Periodontitis']}, 'descriptionModule': {'briefSummary': 'Human periodontitis is a group of highly prevalent oral inflammatory diseases and infections with relatively easy treatment and preventive features. The present study is aimed to determine if treating human individuals with chronic periodontitis, along with the use of antibiotics, reduces cardiovascular risk marker (HsPCR) and also intends to identify if severity of periodontitis could be associated with a raise of systemic inflammatory biomarkers on baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* must be of legal age (≥ 18 years old)\n* voluntary participation and signed information consent\n* confirmed systemically healthy individual\n* at least 15 teeth present in mouth\n\nExclusion Criteria\n\n* pregnant women\n* smokers\n* antibiotic consumption 6 months before inclusion\n* HIV positive or AIDS\n* Allergic reactions to macrolides and specifically to azithromycin\n* Periodontal treatment 6 months before inclusion'}, 'identificationModule': {'nctId': 'NCT01906450', 'briefTitle': 'STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER HIGH SENSITIVE C-REACTIVE PROTEIN. RANDOMIZED CONTROLLED CLINICAL TRIAL.', 'organization': {'class': 'OTHER', 'fullName': 'Universidad del Valle, Colombia'}, 'officialTitle': 'STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER HIGH SENSITIVE C-REACTIVE PROTEIN. RANDOMIZED CONTROLLED CLINICAL TRIAL.', 'orgStudyIdInfo': {'id': 'CL1688'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Scaling and root planing plus Azithromycin', 'description': 'Single session of scaling and root planning. Azithromycin tablets 500mg, 1 tablet every 24 hours for 5 days', 'interventionNames': ['Drug: Scaling and root planing plus Azithromycin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Scaling and root planing plus placebo', 'description': 'Single session of scaling and root planning placebo tablets 500mg, 1 tablet every 24 hours for 3 days', 'interventionNames': ['Drug: Scaling and root planing plus placebo']}, {'type': 'NO_INTERVENTION', 'label': 'baselline screening only', 'description': 'Dental prophylaxis is offered'}], 'interventions': [{'name': 'Scaling and root planing plus Azithromycin', 'type': 'DRUG', 'description': 'Single session of scaling and root planning using ultrasonic device. Azithromycin tablets 500mg, 1 tablet every 24 hours for 5 days', 'armGroupLabels': ['Scaling and root planing plus Azithromycin']}, {'name': 'Scaling and root planing plus placebo', 'type': 'DRUG', 'description': 'Single session of scaling and root planning placebo tablets 500mg, 1 tablet every 24 hours for 3 days', 'armGroupLabels': ['Scaling and root planing plus placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cali', 'country': 'Colombia', 'facility': 'Universidad Del Valle', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad del Valle, Colombia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'periodontist Cert. DDS', 'investigatorFullName': 'Jorge Enrique Soto', 'investigatorAffiliation': 'Universidad del Valle, Colombia'}}}}