Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT06073704
Status:
RECRUITING
Last Update Posted:
2024-12-05
First Post:
2023-09-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Adjunct Antimicrobial Photodynamic Therapy in Periodontal Treatment of Patients with Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010778', 'term': 'Photochemotherapy'}, {'id': 'D014080', 'term': 'Tooth Exfoliation'}, {'id': 'D016745', 'term': 'Root Planing'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D010789', 'term': 'Phototherapy'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will be masked using a sham laser. Outcomes assessor will be blinded in relation to naming of the experimental groups.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2023-09-25', 'studyFirstSubmitQcDate': '2023-10-02', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Probing depth', 'timeFrame': 'Baseline, 1, 3 and 6 months', 'description': 'Changes in probing depth measured from the gingival margin to the bottom of periodontal sulcus or periodontal pocket by a periodontal probe in millimeters.'}, {'measure': 'Clinical attachment level', 'timeFrame': 'Baseline, 1, 3 and 6 months', 'description': 'Changes in clinical attachment level measured from the cemento-enamel junction to the bottom of periodontal sulcus or periodontal pocket by a periodontal probe in millimeters.'}], 'secondaryOutcomes': [{'measure': 'Changes on bleeding on probing', 'timeFrame': 'Baseline, 1,3,and 6 months', 'description': 'Changes in percentage of sites with bleeding after probing. Six sites per tooth are examined and presence/absence of bleeding is recorded.'}, {'measure': 'Differences in proteomics', 'timeFrame': 'baseline, 3 and 6 months', 'description': 'Changes in inflammatory proteins after treatment by proteomics assay. Presence or absence of proteins in gingival fluid are compared before and after treatment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['periodontitis', 'obesity'], 'conditions': ['Periodontitis', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '29111391', 'type': 'BACKGROUND', 'citation': 'Vohra F, Akram Z, Bukhari IA, Sheikh SA, Javed F. Short-term effects of adjunctive antimicrobial photodynamic therapy in obese patients with chronic periodontitis: A randomized controlled clinical trial. Photodiagnosis Photodyn Ther. 2018 Mar;21:10-15. doi: 10.1016/j.pdpdt.2017.10.022. Epub 2017 Oct 27.'}, {'pmid': '37062511', 'type': 'BACKGROUND', 'citation': 'da Silva-Junior PGB, Abreu LG, Costa FO, Cota LOM, Esteves-Lima RP. The effect of antimicrobial photodynamic therapy adjunct to non-surgical periodontal therapy on the treatment of periodontitis in individuals with type 2 diabetes mellitus: A systematic review and meta-analysis. Photodiagnosis Photodyn Ther. 2023 Jun;42:103573. doi: 10.1016/j.pdpdt.2023.103573. Epub 2023 Apr 14.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the effects of adjuvant antimicrobial photodynamic therapy (aPDT) as an adjuvant of scaling and root planing with scaling and root planing alone for periodontal treatment in patients with periodontal disease and obesity. The main question it aims to answer are: Does adjuvant aPDT improves periodontal health? Are there differences in the proteomic profile of gingival fluid after both treatments? Participants will receive scaling and root planing complemented or not by aPDT. Results will be collected after 1, 3, and 6 months. Researchers will compare adjuvant aPDT treatment to regular treatment to see if it promotes reduction in inflammation and improvement in periodontal health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obesity (grade II and III classified according to Body Mass Index)\n* Periodontitis stage II to IV\n* Presence of at least 20 teeth excluding 3rd molars.\n\nExclusion Criteria:\n\n* Smokers\n* Alcohol or drugs consumption\n* Kidney disorders\n* Pregnancy or lactation\n* Use of antibiotics at the last 30 days\n* Use of drugs that alter periodontal structures as phenytoin or ciclosporin\n* Periodontal treatment at the last 6 months'}, 'identificationModule': {'nctId': 'NCT06073704', 'briefTitle': 'Effects of Adjunct Antimicrobial Photodynamic Therapy in Periodontal Treatment of Patients with Obesity', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Effects of Antimicrobial Photodynamic Therapy in Non-surgical Periodontal Treatment of Patients with Obesity', 'orgStudyIdInfo': {'id': 'Obesity and Periodontitis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Antimicrobial Photodynamic therapy adjunct to scaling and root planing', 'description': 'Treatment of scaling and root planing followed by antimicrobial photodynamic therapy with methylene blue (100 micrograms/ml) and red laser', 'interventionNames': ['Procedure: antimicrobial photodynamic therapy (aPDT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Treatment of scaling and root planing.', 'interventionNames': ['Procedure: Control']}], 'interventions': [{'name': 'antimicrobial photodynamic therapy (aPDT)', 'type': 'PROCEDURE', 'otherNames': ['Photodynamic therapy', 'Photochemotherapy'], 'description': 'Scaling and root planing followed by antimicrobial photodynamic therapy', 'armGroupLabels': ['Antimicrobial Photodynamic therapy adjunct to scaling and root planing']}, {'name': 'Control', 'type': 'PROCEDURE', 'otherNames': ['scaling and root planing'], 'description': 'Treatment of scaling and root planing', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17012-901', 'city': 'Bauru', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Carla Damante, PhD', 'role': 'CONTACT', 'email': 'cdamante@usp.br', 'phone': '+55 14 32266064'}, {'name': 'Andreia Pavani, PhD', 'role': 'CONTACT', 'email': 'a-deia@hotmail.com', 'phone': '+55 14 32358366'}, {'name': 'Carla Damante, PhD', 'role': 'CONTACT'}, {'name': 'Andreia Pavani, PhD', 'role': 'CONTACT'}], 'facility': 'Bauru School of Dentistry', 'geoPoint': {'lat': -22.31472, 'lon': -49.06056}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Carla Andreotti Damante', 'investigatorAffiliation': 'University of Sao Paulo'}}}}