Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 6:14 AM
Study NCT ID:
NCT00946634
Status:
COMPLETED
Last Update Posted:
2011-10-04
First Post:
2009-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ozone Therapy in Endodontic Practice, in Vivo Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010126', 'term': 'Ozone'}], 'ancestors': [{'id': 'D010100', 'term': 'Oxygen'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-02', 'studyFirstSubmitDate': '2009-07-23', 'studyFirstSubmitQcDate': '2009-07-24', 'lastUpdatePostDateStruct': {'date': '2011-10-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceleration in repair by healing of apical periodontite', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Primary Apical Periodontite']}, 'descriptionModule': {'briefSummary': 'The ozone therapy has been coming up as a new therapeutic modality. Medicine has been practicing since XIX century and counted great results. It is indicated for the treatment of 260 different pathologies. The researches in Dentistry has showed promising results, indicating a wide spread action in whole dental specialties. The great oxidative power of ozone provides a great antimicrobial effect and it increases the adenosine triphosphate (ATP) synthesis that can be considered as a general improvement of the cell metabolism, which can potentize the repair process. Thus, these facts justify the present study which will assess the increase of speed of apical periodontite repair.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy patients\n* Radiographic evidence of apical periodontite\n* No previous root canal treatment\n\nExclusion Criteria:\n\n* Unhealthy patients\n* Regular response to sensibility test\n* Previous root canal treatment'}, 'identificationModule': {'nctId': 'NCT00946634', 'briefTitle': 'Ozone Therapy in Endodontic Practice, in Vivo Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Phase 4 - Ozone Therapy in Endodontic Practice, in Vivo Study', 'orgStudyIdInfo': {'id': 'CEP 154/06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ozone Gas', 'description': 'Endodontic protocol preconized by University of Sao Paulo associated to ozone gas 40 mg/L', 'interventionNames': ['Drug: Ozone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Regular endodontic protocol preconized by University of Sao Paulo', 'interventionNames': ['Drug: Control (no last irrigation)']}, {'type': 'EXPERIMENTAL', 'label': 'Aqueous Ozone', 'description': 'Endodontic protocol preconized by University of Sao Paulo associated to Aqueous ozone 40mg/L', 'interventionNames': ['Drug: Aqueous Ozone']}], 'interventions': [{'name': 'Ozone', 'type': 'DRUG', 'otherNames': ['Group 2'], 'description': 'Regular endodontic protocol preconized by University of Sao Paulo. Root canal irrigation with 1% Sodium Hypochlorite associated to Endo PTC (10mL), final irrigation with EDTA-T 17% remaining for 3 minutes. After a last foaming with ozone gas (Philozon, Santa Catarina, Brazil) at 40mg/L concentration.', 'armGroupLabels': ['Ozone Gas']}, {'name': 'Control (no last irrigation)', 'type': 'DRUG', 'otherNames': ['Group 1'], 'description': 'Regular endodontic protocol preconized by University of Sao Paulo. Root canal irrigation with 1% Sodium Hypochlorite associated to Endo PTC (10mL), final irrigation with EDTA-T 17% remaining for 3 minutes.', 'armGroupLabels': ['Control']}, {'name': 'Aqueous Ozone', 'type': 'DRUG', 'otherNames': ['Group 3'], 'description': 'Regular endodontic protocol preconized by University of Sao Paulo. Root canal irrigation with 1% Sodium Hypochlorite associated to Endo PTC (10mL), final irrigation with EDTA-T 17% remaining for 3 minutes. A last irrigation with 10mL of ozonated water at 40mg/mL concentration', 'armGroupLabels': ['Aqueous Ozone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05508-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Fundação para o Desenvolvimento Científico e Tecnológico da Odontologia of University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'José L Lage-Marques, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master', 'investigatorFullName': 'Carlos Goes Nogales', 'investigatorAffiliation': 'University of Sao Paulo'}}}}