Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 4:21 AM
Study NCT ID:
NCT07463859
Status:
RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D006209', 'term': 'Halitosis'}, {'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014080', 'term': 'Tooth Exfoliation'}, {'id': 'D016745', 'term': 'Root Planing'}, {'id': 'D010778', 'term': 'Photochemotherapy'}], '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': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Simulation of laser treatment'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-04-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-03-05', 'studyFirstSubmitQcDate': '2026-03-05', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Halitosis', 'timeFrame': 'From enrollment to the end of treatment at 6 months', 'description': 'Measurement of oral volatile compounds by gas chromatography'}], 'secondaryOutcomes': [{'measure': 'Probing depth', 'timeFrame': 'From enrollment to the end of treatment at 6 months', 'description': 'Measurement in milimeters of the periodontal pocket'}, {'measure': 'Clinical Attachment level', 'timeFrame': 'From enrollment to the end of treatment at 6 months', 'description': 'Measuremet in milimeters from cementoenamel junction to bottom of the pocket'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Halitosis', 'periodontitis', 'lasers', 'Photodynamic Therapy'], 'conditions': ['Type 2 Diabetes', 'Halitosis', 'Periodontitis']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Bruno LH,Mandetta ARH,Sobral APT,Leal Gonçalves ML,Santos EM,Fossati AL,Gallo JMAS,Motta PB,Deana AM,Horliana ACRT,Motta LJ,Ferrari RAM,Santos Fernandes KP,Kalil Bussadori S'}, {'pmid': '33987732', 'type': 'BACKGROUND', 'citation': 'da Mota ACC, Goncalves MLL, Horliana ACRT, Deana AM, de Souza Cavalcante LA, Gomes AO, Mayer MPA, Suguimoto ESA, Fernandes KPS, Mesquita-Ferrari RA, Prates RA, Motta LJ, Bussadori SK. Effect of antimicrobial photodynamic therapy with red led and methylene blue on the reduction of halitosis: controlled microbiological clinical trial. Lasers Med Sci. 2022 Mar;37(2):877-886. doi: 10.1007/s10103-021-03325-x. Epub 2021 May 13.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the effectiveness of periodontal treatment associated with the use of a tongue scraper, compared with the same treatment combined with antimicrobial photodynamic therapy (aPDT), in reducing halitosis in individuals with periodontal disease and type 2 diabetes mellitus. The main question it aims to answer is: aPDT treatment is more effective in treating halitosis? aPDT treatment is more effective in periodontitis? Researchers will compare aPDT treatment to conventional treatment (scaling and root planning and tongue scraper) to see if aPDT has additional effects in reducing halitosis and improving periodontal health.\n\n* Participants will be asked to visit the clinic once a week for exam and treatment during 1 month.\n* After active treatment they will be asked to come to maintenance and control visits once a month until 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with type 2 diabetes mellitus according to the 2019 WHO criteria\n* Stage 3 or 4 periodontitis\n* No periodontal treatment in the previous 12 months\n* a minimum of 20 remaining teeth.\n\nExclusion Criteria:\n\n* Smokers\n* Alcohol-dependent individuals\n* Pregnant or lactating women\n* Patients with renal disorders\n* Patients using medications that affect the periodontium'}, 'identificationModule': {'nctId': 'NCT07463859', 'briefTitle': 'Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabetes Mellitus: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '7.885.095'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'aPDT - antimicrobial photodynamic therapy', 'description': 'Treatment of scaling and root planning plus antimicrobial photodynamic therapy in periodontal pockets. Antimicrobial photodynamic therapy on tongue.', 'interventionNames': ['Procedure: Photodynamic Therapy with Conventional Methylene Blue']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Treatment of periodontal pockets with scaling and root planing and tongue with tongue scraper', 'interventionNames': ['Procedure: Scaling and root planing']}], 'interventions': [{'name': 'Scaling and root planing', 'type': 'PROCEDURE', 'description': 'Mechanical removal of biofilm in periodontal pockets and tongue', 'armGroupLabels': ['Control']}, {'name': 'Photodynamic Therapy with Conventional Methylene Blue', 'type': 'PROCEDURE', 'description': 'Antimicrobial photodynamic therapy in periodontal pockets and tongue', 'armGroupLabels': ['aPDT - antimicrobial photodynamic therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17012901', 'city': 'Bauru', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Carla A. Damante, PhD', 'role': 'CONTACT', 'email': 'cdamante@usp.br', 'phone': '+55 1432266064'}], 'facility': 'Bauru School of Dentistry', 'geoPoint': {'lat': -22.31472, 'lon': -49.06056}}], 'centralContacts': [{'name': 'Carla A. Damante, PhD', 'role': 'CONTACT', 'email': 'cdamante@usp.br', 'phone': '+551432266064'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor - Principal investigator', 'investigatorFullName': 'Carla Andreotti Damante', 'investigatorAffiliation': 'University of Sao Paulo'}}}}