Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-02-27 @ 4:05 PM
Study NCT ID:
NCT02407834
Status:
COMPLETED
Last Update Posted:
2015-04-03
First Post:
2015-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Hygiene Solutions on Denture Biofilm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013280', 'term': 'Stomatitis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C079198', 'term': 'S 1 (combination)'}, {'id': 'D012973', 'term': 'Sodium Hypochlorite'}, {'id': 'D004837', 'term': 'Epinephrine'}, {'id': 'D002368', 'term': 'Castor Oil'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D006997', 'term': 'Hypochlorous Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-02', 'studyFirstSubmitDate': '2015-02-09', 'studyFirstSubmitQcDate': '2015-04-02', 'lastUpdatePostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'biofilm removal capacity using Image Tool software', 'timeFrame': '7 days'}, {'measure': 'antimicrobial action against specific microorganisms by Colony Forming Units counts', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'remission of atrophic chronic candidiasis using multinomial logistic regression analysis', 'timeFrame': '7 days'}, {'measure': 'degree of patient satisfaction assessed by specific questionnaire', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Biofilms', 'Dentures', 'Denture Cleansers', 'Castor Oil', 'Stomatitis'], 'conditions': ['Stomatitis']}, 'descriptionModule': {'briefSummary': 'This clinical trial evaluated Ricinus communis and sodium hypochlorite solutions in different concentrations for denture cleanliness, regarding biofilm removal capacity, remission of atrophic chronic candidiasis, degree of patient satisfaction and antimicrobial action against specific microorganism. Sixty-four denture wearers with absence (n=40) or presence of Candidiasis (n=24) were selected and oriented to brush their dentures with a specific brush and neutral soap for 3 minutes, 3 times a day and immerse them, once a day, in hygiene solutions (0.25% sodium hypochlorite - S1 and 0.5% - S2, 10% R. communis - S3; Saline - S4: control) during 20 minutes, for 7 days. The solutions were used in a randomized, double blind and cross form with washout periods. To quantify biofilm with software ImageTool 3.0, the inner surface was disclosed (1% neutral red) and photographed at the end of each period. The Candidiasis remission was assessed by scores before and after the use of solutions. Patient satisfaction was assessed by questionnaire. Antimicrobial activity was determined by Colony Forming Units (CFU) counts of Streptococcus mutans, Candida spp., and gram-negative microorganisms. For collecting biofilm, internal surface of each maxillary complete denture was brushed with saline solution, and the biofilm suspension obtained. After serial dilutions (100 - 10-3), 50 uL aliquots were seeded in Petri dishes containing Mitis salivarius agar base, CHROMagar Candida® and MacConkey agar for detecting S. mutans, Candida spp., or gram-negative microorganisms, respectively. After incubation, colonies were counted, and values in CFU/mL were calculated. Biofilm removal was analyzed as a split-plot with two variation factors: inflammation and solutions. The candidiasis remission was analyzed after adjustment using multinomial logistic regression. Logistic regression analysis and compound symmetry was adopted for patient satisfaction. The antimicrobial action was analyzed with Friedman´s test. Antimicrobial action data were processed after transformation - log10 (CFU + 1) - and were analyzed by Friedman test (α = 0.05).', 'detailedDescription': 'Sixty-four denture wearers with (n=24) and without Candidiasis (n=40) were enrolled and instructed to brush and immerse their dentures in 4 different storage solutions (S1: 0.25% sodium hypochlorite; S2: 0.5% sodium hypochlorite; S3: 10% R. communis; and S4: Saline/Control). The interventions were randomly performed in a double blind and crossover format with washout periods. After 7 days of brushing and storage, the biofilm formed in the inner surfaces of dentures was disclosed and photographed to quantification. Candidiasis remission was assessed by scores and the patient satisfaction by a questionnaire. Antimicrobial activity of the solutions was determined by counting the Colony Forming Units (CFUs) of Streptococcus mutans, Candida spp., and gram-negative microorganisms. For collecting biofilm, each complete upper denture was placed in a Petri dish, its internal surface was brushed (Tek brush) with saline solution for 2 min, and the biofilm suspension was transferred to a test tube. After serial dilutions (100 - 10-3), 50 uL aliquots were seeded in Petri dishes containing Mitis salivarius agar base, CHROMagar Candida® and MacConkey agar for detecting S. mutans, Candida spp., or gram-negative microorganisms, respectively. After incubation, colonies were counted, and values in CFU/mL were calculated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Edentulous that make regular use of dentures in acrylic resin for at least one year with the presence of biofilm.\n\nExclusion Criteria:\n\n* Problems in adapting, reline, or repair fractures\n* Patients with limited communication or collaboration as the following recommended protocol.'}, 'identificationModule': {'nctId': 'NCT02407834', 'briefTitle': 'Effectiveness of Hygiene Solutions on Denture Biofilm', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Clinical Evaluation of an Experimental Solution Based on Ricinus Communis Compared to Sodium Hypochlorite for Denture Cleansing', 'orgStudyIdInfo': {'id': 'mestradopt2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'S1 - 0.25% sodium hypochlorite', 'description': 'Brushing with specific brush and neutral soap, three times a day. After, immesion in 0.25% sodium hypochlorite during 20 minutes, once a day. This protocol was used during 7 days.', 'interventionNames': ['Other: S1']}, {'type': 'EXPERIMENTAL', 'label': 'S2 - 0.5% sodium hypochlorite', 'description': 'Brushing with specific brush and neutral soap, three times a day. After, immesion in 0.5% sodium hypochlorite during 20 minutes, once a day.This protocol was used during 7 days.', 'interventionNames': ['Other: S2']}, {'type': 'EXPERIMENTAL', 'label': 'S3 - 10% Ricinus communis', 'description': 'Brushing with specific brush and neutral soap, three times a day. After, immesion in 10% Ricinus communis solution during 20 minutes, once a day. This protocol was used during 7 days.', 'interventionNames': ['Other: S3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'S4 - saline solution', 'description': 'Brushing with specific brush and neutral soap, three times a day. After, immesion in saline solution during 20 minutes, once a day. This protocol was used during 7 days.', 'interventionNames': ['Other: S4']}], 'interventions': [{'name': 'S1', 'type': 'OTHER', 'otherNames': ['0.25% sodium hypochlorite'], 'description': 'Immersion in 0.25% sodium hypochlorite for 20 minutes, during 7 days.', 'armGroupLabels': ['S1 - 0.25% sodium hypochlorite']}, {'name': 'S2', 'type': 'OTHER', 'otherNames': ['0.5% sodium hypochlorite'], 'description': 'Immersion in 0.5% sodium hypochlorite for 20 minutes, during 7 days.', 'armGroupLabels': ['S2 - 0.5% sodium hypochlorite']}, {'name': 'S3', 'type': 'OTHER', 'otherNames': ['10% ricinus communis'], 'description': 'Immersion in 10% Ricinus communis for 20 minutes, during 7 days.', 'armGroupLabels': ['S3 - 10% Ricinus communis']}, {'name': 'S4', 'type': 'OTHER', 'otherNames': ['saline solution'], 'description': 'Immersion in Saline solution for 20 minutes, during 7 days.', 'armGroupLabels': ['S4 - saline solution']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}, {'name': 'Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cláudia Helena Lovato da Silva', 'investigatorFullName': 'Cláudia Helena Lovato da Silva', 'investigatorAffiliation': 'University of Sao Paulo'}}}}