Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-01-27 @ 6:07 PM
Study NCT ID:
NCT02337192
Status:
COMPLETED
Last Update Posted:
2015-01-13
First Post:
2014-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antimicrobial Photodynamic Therapy Applied in Orthodontic. Orthodontic Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003474', 'term': 'Curcumin'}, {'id': 'C000726252', 'term': 'TBP1901'}, {'id': 'D013501', 'term': 'Surface-Active Agents'}, {'id': 'D004121', 'term': 'Dimethyl Sulfoxide'}, {'id': 'D014867', 'term': 'Water'}, {'id': 'C010882', 'term': 'chlorhexidine gluconate'}], 'ancestors': [{'id': 'D036381', 'term': 'Diarylheptanoids'}, {'id': 'D006536', 'term': 'Heptanes'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-08', 'studyFirstSubmitDate': '2014-12-04', 'studyFirstSubmitQcDate': '2015-01-08', 'lastUpdatePostDateStruct': {'date': '2015-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microbiological analysis by the total number of colony-forming units (CFU)', 'timeFrame': 'one section ( one hour)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Orthodontic, Photochemoterapy'], 'conditions': ['Dentist-Patient Relations']}, 'referencesModule': {'references': [{'pmid': '24703280', 'type': 'RESULT', 'citation': 'Iliadi A, Baumgartner S, Athanasiou AE, Eliades T, Eliades G. Effect of intraoral aging on the setting status of resin composite and glass ionomer orthodontic adhesives. Am J Orthod Dentofacial Orthop. 2014 Apr;145(4):425-33. doi: 10.1016/j.ajodo.2013.11.020.'}]}, 'descriptionModule': {'briefSummary': "We demonstrated the use of the Antimicrobial Photodynamic Therapy as a coadjutant oral decontamination agent. It was also shown that SDS surfactant improves the antibacterial action of APDT when using Curcumin as the photosensitizer. The decontamination levels obtained with APDT are comparable with the levels observed with the use of Chlorhexidine. The clinical relevancy is the control of oral microbial load which will improve the patients' quality of life and will decrease the possibility of cross contamination in the dental office.", 'detailedDescription': 'The installation of the orthodontic appliances promotes an increase in the retentive area available for microbial aggregation, difficult the oral health promotion and, in addition, promotes the artificial selection of biofilms containing a higher load of pathogenic microorganisms. In this way, it becomes of critical importance, the development of techniques that might aid in the reduction of the oral microbial load. One possible approach is the use of the Antimicrobial Photodynamic Therapy (APDT). In this direction, the objective of this study was to assess the clinical utility of the APDT and the association of the APDT with the SDS surfactant as oral decontamination agents in orthodontic patients. The selected patients (n=24) were randomly distributed within seven experimental groups: G1 - Negative control, G2 - Curcumin mouthwash, G3 - Curcumin mouthwash+SDS, G4 - light irradiation, G5 - APDT, G6 - APDT+SDS and G7 - Positive Control (Chlorhexidine mouthwash). Nonstimulated saliva samples were collected from each one of the patients in three steps (S), as follows: S1- Initial condition, S2 - Treatment with mouthwashes (water, Chlorhexidine or Curcumin) and S3 - After APDT treatment. The efficacy of the proposed treatment protocols was assessed in function of the survival fraction observed in each group. The obtained results were statistically analyzed using variance analysis (ANOVA) and the Kruskal-Wallis test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria were: being under fixed orthodontic treatment, absence of clinical signs of periodontal disease, not used antibiotics 90 days prior to the participation on this study and not use fluoride mouthwashes.\n\nExclusion Criteria:\n\n* Exclusion criteria were: signs of uncontrolled systemic diseases (diabetes, high blood pressure and heart conditions), breast feeding or pregnant women, patients with oral tumors and patients with history of allergy to any of the materials used, such as Curcumin and Chlorhexidine.'}, 'identificationModule': {'nctId': 'NCT02337192', 'briefTitle': 'Antimicrobial Photodynamic Therapy Applied in Orthodontic. Orthodontic Patients.', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Oral Decontamination Using Antimicrobial Photodynamic Therapy Applied in Orthodontic Patients.', 'orgStudyIdInfo': {'id': 'orto14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Negative control - Moutwash with 1,5mL of dimethyl sulfoxide at 5% (DMSO) in water solution - During 2 minutes.', 'interventionNames': ['Drug: DMSO + water']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Mouthwash with Swish with Curcumin', 'interventionNames': ['Drug: Curcumin']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'Moutwash with Swish with Curcumin + SDS', 'interventionNames': ['Drug: Curcumin', 'Drug: Surfactant']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4', 'description': 'Experiment use dental irradiation with blue light (LED) only.', 'interventionNames': ['Device: LED']}, {'type': 'EXPERIMENTAL', 'label': 'Group 5', 'description': 'Antimicrobial Photodynamic Therapy (APDT) with blue light and Curcumin salt.', 'interventionNames': ['Drug: Curcumin', 'Device: LED']}, {'type': 'EXPERIMENTAL', 'label': 'Group 6', 'description': 'Antimicrobial Photodynamic Therapy (APDT) with blue light, Curcumin salt and surfactant.', 'interventionNames': ['Drug: Curcumin', 'Device: LED', 'Drug: Surfactant']}, {'type': 'EXPERIMENTAL', 'label': 'Group 7', 'description': 'Positive control - Use of mouthwash with Chlorhexidine only', 'interventionNames': ['Drug: Chlorhexidine gluconate']}], 'interventions': [{'name': 'Curcumin', 'type': 'DRUG', 'otherNames': ['Curcumin salt'], 'armGroupLabels': ['Group 2', 'Group 3', 'Group 5', 'Group 6']}, {'name': 'LED', 'type': 'DEVICE', 'armGroupLabels': ['Group 4', 'Group 5', 'Group 6']}, {'name': 'Surfactant', 'type': 'DRUG', 'armGroupLabels': ['Group 3', 'Group 6']}, {'name': 'DMSO + water', 'type': 'DRUG', 'armGroupLabels': ['Group 1']}, {'name': 'Chlorhexidine gluconate', 'type': 'DRUG', 'armGroupLabels': ['Group 7']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13560-970', 'city': 'São Carlos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Vitor Hugo Panhóca', 'geoPoint': {'lat': -22.0175, 'lon': -47.89083}}], 'overallOfficials': [{'name': 'Vitor H Panhóca, Ms', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vitor Hugo Panhóca', 'investigatorFullName': 'Fernanda Rossi Paolillo', 'investigatorAffiliation': 'University of Sao Paulo'}}}}