Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-01-27 @ 3:55 PM
Study NCT ID:
NCT02769260
Status:
UNKNOWN
Last Update Posted:
2016-05-11
First Post:
2016-04-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Biofilm Characteristics Between an in Situ Biofilm Model of Supragingival Plaque and Natural Teeth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003773', 'term': 'Dental Plaque'}], 'ancestors': [{'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014099', 'term': 'Toothbrushing'}], 'ancestors': [{'id': 'D009910', 'term': 'Oral Hygiene'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-08', 'studyFirstSubmitDate': '2016-04-20', 'studyFirstSubmitQcDate': '2016-05-08', 'lastUpdatePostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bacterial viability', 'timeFrame': 'Bacterial viability measured in proportion of viable/no viable bacteria after 48 hours of exposition to oral cavity', 'description': 'It will be measured by analysis of images taken by Confocal laser Scanning Microscope'}, {'measure': 'Bacterial diversity', 'timeFrame': 'Bacterial diversity measured by microbial estimators of abundance and richness after 48 hours of exposition to oral cavity', 'description': 'It will be measured by 16S rDNA gene pyrosequencing and posterior bioinformatic analysis.'}], 'secondaryOutcomes': [{'measure': 'Biofilm thickness', 'timeFrame': 'Oral biofilm thickness measured by analysis of sectional images after 48 hours of exposition to oral cavity', 'description': 'It will be measured by analysing sectional images taken by Confocal Laser Scanning Microscope.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pyrosequencing', '16S DNA gene', 'Confocal Laser Scanning Microscope', 'bacterial viability', 'bacterial diversity'], 'conditions': ['Biofilm', 'Dental Plaque']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine in situ the bacterial viability, thickness and bacterial diversity of a biofilm formed on different substrates in comparison to a naturally tooth-formed oral biofilm. In addition, it will be evaluated whether the restraint of oral hygiene measures may influence the development of the PL-Biofilm.', 'detailedDescription': '* To calculate an a priori sample size, the following statistical criteria were established: an effect size of 0.35, an alpha error of 0.05 and a statistical power of 87%. Assuming these criteria and using the repeated measures ANOVA test, a sample size of 15 subjects was required.\n* Bacterial viability and thickness will be analyse by Confocal Laser Scanning Microscope and Live/Dead BackLight staining solution.\n* Bacterial diversity will be analyse by Pyrosequencing the 16S DNAr gene.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* systemically healthy\n* good oral health status\n\nExclusion Criteria:\n\n* smoker or former smoker,\n* presence of dental prostheses or orthodontic devices,\n* antibiotic treatment or routine use of oral antiseptics in the previous 3 months,\n* presence of any systemic disease that could alter the production or composition of saliva'}, 'identificationModule': {'nctId': 'NCT02769260', 'briefTitle': 'Comparison of Biofilm Characteristics Between an in Situ Biofilm Model of Supragingival Plaque and Natural Teeth', 'organization': {'class': 'OTHER', 'fullName': 'University of Santiago de Compostela'}, 'officialTitle': 'Comparison of Biofilm Characteristics Between an in Situ Biofilm Model of Supragingival Plaque and Natural Teeth', 'orgStudyIdInfo': {'id': 'Pyro-Biofilm'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No toothbrushing during experiment and Pyrosequencing', 'description': 'Volunteers will not brush their teeth during 48 hours. Dental plaque samples will be analyse by CLSM (confocal Laser scanning microscope) and 16S DNA pyrosequencing.'}, {'type': 'NO_INTERVENTION', 'label': 'No toothbrushing during experiment', 'description': 'Volunteers will not brush their teeth during 48 hours. Dental plaque samples will be analyse by CLSM (confocal Laser scanning microscope).'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Toothbrushing during experiment', 'description': '48hours-Dental plaque samples will be analyse by CLSM (confocal Laser scanning microscope).', 'interventionNames': ['Other: Toothbrushing']}], 'interventions': [{'name': 'Toothbrushing', 'type': 'OTHER', 'description': 'Normal toothbrushing without toothpaste or antiseptic mouthwash.', 'armGroupLabels': ['Toothbrushing during experiment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15782', 'city': 'Santiago de Compostela', 'state': 'Galicia/ A Coruña', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Inmaculada Tomás Carmona, S Lecturer', 'role': 'CONTACT', 'email': 'inmaculada.tomas@usc.es', 'phone': '981563100', 'phoneExt': '12384'}, {'name': 'Isabel Prada, PHD student', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Víctor Quintas, PHD student', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Inmaculada Tomás Camona, S Lecture', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Univeristy of Santiago de Compostela, Faculty of Dentistry', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}], 'centralContacts': [{'name': 'Inmaculada Tomás Carmona, S Lecturer', 'role': 'CONTACT', 'email': 'inmaculada.tomas@usc.es', 'phone': '981563100', 'phoneExt': '12384'}], 'overallOfficials': [{'name': 'Inmaculada Tomás Carmona, S Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univeristy of Santiago de Compostela'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data will shared in a supplementary file in the published paper'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Santiago de Compostela', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Lecture', 'investigatorFullName': 'Inmaculada Tomas', 'investigatorAffiliation': 'University of Santiago de Compostela'}}}}