Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-03 @ 5:38 PM
Study NCT ID:
NCT03100435
Status:
COMPLETED
Last Update Posted:
2023-03-31
First Post:
2017-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Er:YAG Laser in Decontamination of Dental Implants: An In-Vitro Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D057873', 'term': 'Peri-Implantitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053844', 'term': 'Lasers, Solid-State'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'robert.gyurko@tufts.edu', 'phone': '6176366531', 'title': 'Robert Gyurko', 'organization': 'Tufts University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 days (the duration of wearing the intraoral appliance)', 'eventGroups': [{'id': 'EG000', 'title': 'Er:YAG Laser', 'description': 'Er:YAG Laser only\n\nEr:YAG Laser: Titanium disks will be decontaminated ex-vivo with the Er:YAG laser.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Carbon Fiber Curette', 'description': 'Carbon fiber curette only\n\nCarbon Fiber Curette: Titanium disks will be decontaminated ex-vivo with carbon fiber curettes', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Er:YAG Laser + Carbon Fiber Curette', 'description': 'Combination of Er:YAG Laser and carbon fiber curette\n\nEr:YAG Laser: Titanium disks will be decontaminated ex-vivo with the Er:YAG laser.\n\nCarbon Fiber Curette: Titanium disks will be decontaminated ex-vivo with carbon fiber curettes', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'No Treatment', 'description': 'No treatment (control)', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Titanium disc dislodged from appliance', 'notes': 'Titanium discs were dislodged from the appliance in 2 of the 8 participants. Dislodged discs were excluded from the analysis.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Bacteria Biofilm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}, {'units': 'Titanium disks', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser', 'description': 'Titanium disks are decontaminated ex-vivo with the Er:YAG laser.'}, {'id': 'OG001', 'title': 'Curette', 'description': 'Titanium disks are decontaminated ex-vivo with carbon fiber curettes'}, {'id': 'OG002', 'title': 'Brush', 'description': 'Titanium disks are decontaminated ex-vivo with titanium brush'}, {'id': 'OG003', 'title': 'Control', 'description': 'Titanium disks are not decontaminated'}], 'classes': [{'categories': [{'measurements': [{'value': '32.78', 'spread': '24', 'groupId': 'OG000'}, {'value': '20.14', 'spread': '19.15', 'groupId': 'OG001'}, {'value': '11.8', 'spread': '10.29', 'groupId': 'OG002'}, {'value': '74.03', 'spread': '21.61', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 days', 'description': 'Percent area of the titanium disc covered by bacteria biofilm', 'unitOfMeasure': 'percentage of disc covered', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Titanium disks', 'denomUnitsSelected': 'Titanium disks', 'populationDescription': 'From 64 collected titanium disks, 5 were removed from analysis. 4 disks were dislodged from 2 enrolled participants and 1 disk was excluded due to improper magnification of the SYTO 9 imaging.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'Each participant provides 2 Titanium disks that are decontaminated ex-vivo with the Er:YAG laser, with carbon fiber curette, with titanium brush, or not decontaminated.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '64', 'numSubjects': '8'}]}, {'type': 'YAG Laser', 'achievements': [{'groupId': 'FG000', 'numUnits': '16', 'numSubjects': '8'}]}, {'type': 'Carbon Fiber Curette', 'achievements': [{'groupId': 'FG000', 'numUnits': '16', 'numSubjects': '8'}]}, {'type': 'Titanium Brush', 'achievements': [{'groupId': 'FG000', 'numUnits': '16', 'numSubjects': '8'}]}, {'type': 'Not Decontaminated', 'achievements': [{'groupId': 'FG000', 'numUnits': '16', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '59', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': '2 titanium disks per enrollee per arm', 'recruitmentDetails': 'From May 2017 to August 2018, 8 enrollments were made in the Department of Periodontology at Tufts University School of Dental Medicine', 'preAssignmentDetails': 'Each subject participates in each arm, as 2 titanium discs from each subject are distributed among all 4 arms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Titanium disks are decontaminated ex-vivo with the Er:YAG laser, with carbon fiber curettes, with titanium brush, or are not decontaminated .'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.6', 'spread': '1.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Indian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Each participant contributes 2 titanium discs to each arm therefore creating 64 discs to analyze across 4 arms.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-10', 'size': 942034, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-24T12:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All participants will wear a mouth guard holding 8 titanium discs for 3 days, during which time a natural bacterial biofilm will form on the disc surfaces. After 3 days, the discs will be removed from the mouthguard, and treated ex vivo with different decontamination methods.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-03', 'studyFirstSubmitDate': '2017-03-29', 'resultsFirstSubmitDate': '2022-02-18', 'studyFirstSubmitQcDate': '2017-03-29', 'lastUpdatePostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-03', 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Bacteria Biofilm', 'timeFrame': '3 days', 'description': 'Percent area of the titanium disc covered by bacteria biofilm'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Peri-Implantitis']}, 'descriptionModule': {'briefSummary': 'The American Association of Oral and Maxillofacial Surgeons estimated that 69% of adults ages 35 to 44 have lost at least one permanent tooth. Dental implants have revolutionized dentistry by providing tooth-like replacement for missing teeth and a solution that is predictable with long-term success..\n\nAfter the implant is placed, natural bacteria from the mouth can develop around implants just like around natural teeth. Studies have shown that bacterial contamination can cause peri-implantitis- gum disease or inflammation around the implant, eventually leading to bone loss. Removing bacteria from dental implant surfaces can prevent peri-implantitis, and surface debridement constitutes the basis of treatment of peri-implant disease.\n\nTypically, mechanical hand instrumentation using curettes to remove biofilm and calculus is the main basis for periodontal therapy. However, total debridement is difficult, and the hand tools may damage the surface of the implant and making it more plaque retentive. Studies have shown that mechanical non-surgical therapy alone is not sufficient to treat peri-implantitis.\n\nThere is evidence that a dental laser may be an effective method to remove bacteria from implant surfaces, with less damage to the surface. One type of dental laser, Er:YAG, appears optimal for implant decontamination as the Er:YAG laser energy is primarily absorbed by water, resulting in vaporization of bacteria and minimal surface alterations on the implant surface.The aim of this study is to evaluate the efficiency of biofilm decontamination of Er:YAG laser compared to carbon fiber curette.', 'detailedDescription': 'The aim of this study is to compare the amount of residual biofilm on titanium discs after decontamination with Er:YAG laser and carbon fiber curette.\n\nIn the first phase of the study, custom mouth guards that holds multiple titanium discs will be fabricated. Experimental subjects will be instructed to wear this mouth guard for 72 hours, during which time a natural bacterial biofilm will form on the disc surfaces.\n\nThe second phase of the study will be performed ex vivo after collecting the discs from the subjects. Discs retrieved from each mouth guard will be randomized over the 4 treatment groups, so that each subject will contribute two discs to each treatment group: 1) Er:YAG laser, 2) carbon fiber curette, 3) combination of carbon fiber curette and Er:YAG laser, and 4) no treatment (control). The biofilm will be stained and the residual biofilm will be visualized under fluorescence microscopy. Statistical methods will be used to determine the significance of each treatment modality.\n\nThe primary outcome of the study is the percent area of the titanium disc covered by biofilm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of enough teeth to support the mouth guard.\n* Subjects diagnosed with clinical health, gingivitis, or slight chronic periodontitis defined as periodontal inflammation with slight (1-2mm) attachment loss.\n\nExclusion Criteria:\n\n* Subjects with insufficient dental support for the mouth guard\n* Subjects diagnosed with moderate or severe chronic periodontitis.\n* Subjects with known allergy to acrylic or titanium.\n* Subjects who smoke cigarettes, cigars, snuff tobacco, or any other form of smoking.\n* Subjects with a history of antibiotic treatment within the last six months.\n* Subjects with contraindications to wearing a mouth guard, such as chronic obstructive pulmonary disease or severe sleep apnea.\n* Subjects with uncontrolled or debilitating medical conditions, including but not limited to subjects with uncontrolled diabetes, hematologic disorders, cancers, immunosuppression, severe cardiovascular disease, or uncontrolled thyroid disease\n* Subjects that are currently pregnant according to self-report'}, 'identificationModule': {'nctId': 'NCT03100435', 'briefTitle': 'Efficacy of Er:YAG Laser in Decontamination of Dental Implants: An In-Vitro Study', 'organization': {'class': 'OTHER', 'fullName': 'Tufts University'}, 'officialTitle': 'Efficacy of Er:YAG Laser in Decontamination of Dental Implants: An In-Vitro Study', 'orgStudyIdInfo': {'id': '12380'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Er:YAG Laser', 'description': 'Er:YAG Laser only', 'interventionNames': ['Device: Er:YAG Laser']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Carbon Fiber Curette', 'description': 'Carbon fiber curette only', 'interventionNames': ['Other: Carbon Fiber Curette']}, {'type': 'EXPERIMENTAL', 'label': 'Er:YAG Laser + Carbon Fiber Curette', 'description': 'Combination of Er:YAG Laser and carbon fiber curette', 'interventionNames': ['Device: Er:YAG Laser', 'Other: Carbon Fiber Curette']}, {'type': 'NO_INTERVENTION', 'label': 'No Treatment', 'description': 'No treatment (control)'}], 'interventions': [{'name': 'Er:YAG Laser', 'type': 'DEVICE', 'description': 'Titanium disks will be decontaminated ex-vivo with the Er:YAG laser.', 'armGroupLabels': ['Er:YAG Laser', 'Er:YAG Laser + Carbon Fiber Curette']}, {'name': 'Carbon Fiber Curette', 'type': 'OTHER', 'description': 'Titanium disks will be decontaminated ex-vivo with carbon fiber curettes', 'armGroupLabels': ['Carbon Fiber Curette', 'Er:YAG Laser + Carbon Fiber Curette']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts University School of Dental Medicine', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Robert Gyurko, DMD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TUSDM'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Robert Gyurko, DMD, PhD', 'investigatorAffiliation': 'Tufts University'}}}}