Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-31 @ 3:29 PM
Study NCT ID:
NCT03127228
Status:
COMPLETED
Last Update Posted:
2019-11-15
First Post:
2017-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057873', 'term': 'Peri-Implantitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jeffwa@umich.edu', 'phone': '734-763-2105', 'title': 'Dr. Chin-Wei Wang', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Mechanical Debridement', 'description': 'Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with dental scalers.\n\nStandard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 6, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Er:YAG Laser-assisted Debridement', 'description': 'Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with the aid of the laser treatment.\n\nStandard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy\n\nEr:YAG laser-assisted debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with the aid of the laser prior to bone grafting regenerative therapy', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Sinus Tract Infection', 'notes': 'During medical/dental history update participant reported having a sinus tract infection. Dispensed antibiotics and referred participant to their primary care physician.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth pain', 'notes': 'Participant reported tooth pain in lower right quadrant of his mouth. This was a non-study tooth. Participant was referred to his general dentist for care.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flu', 'notes': 'Participant reported having the flu and currently taking antibiotics.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Jaw discomfort', 'notes': 'Participant reported having jaw discomfort in both of his jaw joints. Participant was currently being treated by his general dentist.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Broken filling', 'notes': 'Participant reported having a broken filling on a non-study tooth. Participant had an appointment scheduled with their general dentist for care.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shoulder Pain', 'notes': 'During medical and dental history update the participant reported to have fallen on her shoulder and went to see her primary care physician for treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fistula', 'notes': 'Participant reported having a "water bubble" on the inside of his lower left molar. Upon examination it was determined that the participant could have a root canal infection. Participant was referred to a root canal specialist for treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ulcer on ear', 'notes': 'During the oral exam it was noticed that the participant had an ulcer on his right ear. Participant was referred to this primary care physician for care.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Residual suture', 'notes': 'Participant reported that there was a residual suture in his mouth. Suture was removed.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shingles', 'notes': 'Participant reported that he had shingles and was being treated by his primary care physician.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Crown off', 'notes': 'Participant reported that the crown fell off of his tooth (non-study tooth). Participant was referred to general dentist for treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Type 2 Diabetes', 'notes': 'During medical/dental history review the participant reported to have recently been diagnosed with type 2 diabetes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Periodontal Probing Depths (PD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Mechanical Debridement', 'description': 'Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with dental scalers.\n\nStandard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy'}, {'id': 'OG001', 'title': 'Er:YAG Laser-assisted Debridement', 'description': 'Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with the aid of the laser treatment.\n\nStandard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy\n\nEr:YAG laser-assisted debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with the aid of the laser prior to bone grafting regenerative therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '1.85', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '2.65', 'spread': '2.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 Week', 'description': 'PD will be measured in millimeters. Change in PD measurements were calculated between baseline and 24 weeks.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants'}, {'type': 'PRIMARY', 'title': 'Change in Clinical Attachment Level (CAL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Mechanical Debridement', 'description': 'Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with dental scalers.\n\nStandard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy'}, {'id': 'OG001', 'title': 'Er:YAG Laser-assisted Debridement', 'description': 'Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with the aid of the laser treatment.\n\nStandard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy\n\nEr:YAG laser-assisted debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with the aid of the laser prior to bone grafting regenerative therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '1.47', 'spread': '1.76', 'groupId': 'OG000'}, {'value': '1.90', 'spread': '2.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 Week', 'description': 'CAL will be measured in millimeters. Change in subject CAL measurements were calculated between baseline and 24 weeks.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants'}, {'type': 'PRIMARY', 'title': 'Change in Bleeding on Probing (BOP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Mechanical Debridement', 'description': 'Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with dental scalers.\n\nStandard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy'}, {'id': 'OG001', 'title': 'Er:YAG Laser-assisted Debridement', 'description': 'Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with the aid of the laser treatment.\n\nStandard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy\n\nEr:YAG laser-assisted debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with the aid of the laser prior to bone grafting regenerative therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.39', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '0.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 Week', 'description': 'BOP will be measured dichotomously as 0 or 1. Score 0=no bleeding present Score 1=bleeding present Change in subject BOP score was calculated between baseline and 24 weeks and reported as percent of sites with BOP.', 'unitOfMeasure': 'percentage of sites with BOP', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants'}, {'type': 'PRIMARY', 'title': 'Change in Radiographic Bone Fill (RBF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Mechanical Debridement', 'description': 'Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with dental scalers.\n\nStandard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy'}, {'id': 'OG001', 'title': 'Er:YAG Laser-assisted Debridement', 'description': 'Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with the aid of the laser treatment.\n\nStandard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy\n\nEr:YAG laser-assisted debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with the aid of the laser prior to bone grafting regenerative therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '1.08', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '1.27', 'spread': '1.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 Week', 'description': "Peri-implant bony defect change will be measured compared to baseline. Participants' standardized radiographs were used to determine bone level changes between baseline and 24 weeks.", 'unitOfMeasure': 'Millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Mechanical Debridement', 'description': 'Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with dental scalers.\n\nStandard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy'}, {'id': 'FG001', 'title': 'Er:YAG Laser-assisted Debridement', 'description': 'Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with the aid of the laser treatment.\n\nStandard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy\n\nEr:YAG laser-assisted debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with the aid of the laser prior to bone grafting regenerative therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Mechanical Debridement', 'description': 'Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with dental scalers.\n\nStandard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy'}, {'id': 'BG001', 'title': 'Er:YAG Laser-assisted Debridement', 'description': 'Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with the aid of the laser treatment.\n\nStandard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy\n\nEr:YAG laser-assisted debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with the aid of the laser prior to bone grafting regenerative therapy'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63.41', 'spread': '13.48', 'groupId': 'BG000'}, {'value': '66.41', 'spread': '8.76', 'groupId': 'BG001'}, {'value': '64.91', 'spread': '11.22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-22', 'size': 671240, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-10-03T10:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-31', 'studyFirstSubmitDate': '2017-04-19', 'resultsFirstSubmitDate': '2019-10-12', 'studyFirstSubmitQcDate': '2017-04-23', 'lastUpdatePostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-12', 'studyFirstPostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Periodontal Probing Depths (PD)', 'timeFrame': 'Baseline and 24 Week', 'description': 'PD will be measured in millimeters. Change in PD measurements were calculated between baseline and 24 weeks.'}, {'measure': 'Change in Clinical Attachment Level (CAL)', 'timeFrame': 'Baseline and 24 Week', 'description': 'CAL will be measured in millimeters. Change in subject CAL measurements were calculated between baseline and 24 weeks.'}, {'measure': 'Change in Bleeding on Probing (BOP)', 'timeFrame': 'Baseline and 24 Week', 'description': 'BOP will be measured dichotomously as 0 or 1. Score 0=no bleeding present Score 1=bleeding present Change in subject BOP score was calculated between baseline and 24 weeks and reported as percent of sites with BOP.'}, {'measure': 'Change in Radiographic Bone Fill (RBF)', 'timeFrame': 'Baseline and 24 Week', 'description': "Peri-implant bony defect change will be measured compared to baseline. Participants' standardized radiographs were used to determine bone level changes between baseline and 24 weeks."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Laser'], 'conditions': ['Peri-Implantitis']}, 'referencesModule': {'references': [{'pmid': '21985674', 'type': 'BACKGROUND', 'citation': 'Aljateeli M, Fu JH, Wang HL. Managing peri-implant bone loss: current understanding. Clin Implant Dent Relat Res. 2012 May;14 Suppl 1:e109-18. doi: 10.1111/j.1708-8208.2011.00387.x. Epub 2011 Oct 10.'}, {'pmid': '25867988', 'type': 'BACKGROUND', 'citation': 'Aoki A, Mizutani K, Schwarz F, Sculean A, Yukna RA, Takasaki AA, Romanos GE, Taniguchi Y, Sasaki KM, Zeredo JL, Koshy G, Coluzzi DJ, White JM, Abiko Y, Ishikawa I, Izumi Y. Periodontal and peri-implant wound healing following laser therapy. Periodontol 2000. 2015 Jun;68(1):217-69. doi: 10.1111/prd.12080.'}, {'pmid': '23237585', 'type': 'BACKGROUND', 'citation': 'Atieh MA, Alsabeeha NH, Faggion CM Jr, Duncan WJ. The frequency of peri-implant diseases: a systematic review and meta-analysis. J Periodontol. 2013 Nov;84(11):1586-98. doi: 10.1902/jop.2012.120592. Epub 2012 Dec 13.'}, {'pmid': '18724859', 'type': 'BACKGROUND', 'citation': 'Claffey N, Clarke E, Polyzois I, Renvert S. Surgical treatment of peri-implantitis. J Clin Periodontol. 2008 Sep;35(8 Suppl):316-32. doi: 10.1111/j.1600-051X.2008.01277.x.'}, {'pmid': '23574471', 'type': 'BACKGROUND', 'citation': 'De Bruyn H, Vandeweghe S, Ruyffelaert C, Cosyn J, Sennerby L. Radiographic evaluation of modern oral implants with emphasis on crestal bone level and relevance to peri-implant health. Periodontol 2000. 2013 Jun;62(1):256-70. doi: 10.1111/prd.12004.'}, {'pmid': '25495683', 'type': 'BACKGROUND', 'citation': 'Derks J, Tomasi C. Peri-implant health and disease. A systematic review of current epidemiology. J Clin Periodontol. 2015 Apr;42 Suppl 16:S158-71. doi: 10.1111/jcpe.12334.'}, {'pmid': '16117768', 'type': 'BACKGROUND', 'citation': 'Fransson C, Lekholm U, Jemt T, Berglundh T. Prevalence of subjects with progressive bone loss at implants. Clin Oral Implants Res. 2005 Aug;16(4):440-6. doi: 10.1111/j.1600-0501.2005.01137.x.'}, {'pmid': '19811080', 'type': 'BACKGROUND', 'citation': 'Goncalves F, Zanetti AL, Zanetti RV, Martelli FS, Avila-Campos MJ, Tomazinho LF, Granjeiro JM. Effectiveness of 980-mm diode and 1064-nm extra-long-pulse neodymium-doped yttrium aluminum garnet lasers in implant disinfection. Photomed Laser Surg. 2010 Apr;28(2):273-80. doi: 10.1089/pho.2009.2496.'}, {'pmid': '2520397', 'type': 'BACKGROUND', 'citation': "Jensen MP, Karoly P, O'Riordan EF, Bland F Jr, Burns RS. The subjective experience of acute pain. An assessment of the utility of 10 indices. Clin J Pain. 1989 Jun;5(2):153-9. doi: 10.1097/00002508-198906000-00005."}, {'pmid': '24303954', 'type': 'BACKGROUND', 'citation': 'Kinney JS, Morelli T, Oh M, Braun TM, Ramseier CA, Sugai JV, Giannobile WV. Crevicular fluid biomarkers and periodontal disease progression. J Clin Periodontol. 2014 Feb;41(2):113-120. doi: 10.1111/jcpe.12194. Epub 2013 Dec 12.'}, {'pmid': '12479633', 'type': 'BACKGROUND', 'citation': "Kreisler M, Kohnen W, Marinello C, Gotz H, Duschner H, Jansen B, d'Hoedt B. Bactericidal effect of the Er:YAG laser on dental implant surfaces: an in vitro study. J Periodontol. 2002 Nov;73(11):1292-8. doi: 10.1902/jop.2002.73.11.1292."}, {'pmid': '22551347', 'type': 'BACKGROUND', 'citation': 'Marrone A, Lasserre J, Bercy P, Brecx MC. Prevalence and risk factors for peri-implant disease in Belgian adults. Clin Oral Implants Res. 2013 Aug;24(8):934-40. doi: 10.1111/j.1600-0501.2012.02476.x. Epub 2012 May 3.'}, {'pmid': '28028971', 'type': 'BACKGROUND', 'citation': 'Matys J, Dominiak M. Assessment of Pain When Uncovering Implants with Er:YAG Laser or Scalpel for Second Stage Surgery. Adv Clin Exp Med. 2016 Nov-Dec;25(6):1179-1184. doi: 10.17219/acem/62456.'}, {'pmid': '25006763', 'type': 'BACKGROUND', 'citation': 'Nevins M, Nevins ML, Yamamoto A, Yoshino T, Ono Y, Wang CW, Kim DM. Use of Er:YAG laser to decontaminate infected dental implant surface in preparation for reestablishment of bone-to-implant contact. Int J Periodontics Restorative Dent. 2014 Jul-Aug;34(4):461-6. doi: 10.11607/prd.2192.'}, {'pmid': '23537178', 'type': 'BACKGROUND', 'citation': 'Peri-implant mucositis and peri-implantitis: a current understanding of their diagnoses and clinical implications. J Periodontol. 2013 Apr;84(4):436-43. doi: 10.1902/jop.2013.134001. No abstract available.'}, {'pmid': '19633633', 'type': 'BACKGROUND', 'citation': 'Quaranta A, Maida C, Scrascia A, Campus G, Quaranta M. 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Protein biomarkers and microbial profiles in peri-implantitis. Clin Oral Implants Res. 2016 Sep;27(9):1129-36. doi: 10.1111/clr.12708. Epub 2015 Oct 1.'}, {'pmid': '23342343', 'type': 'BACKGROUND', 'citation': 'Yamamoto A, Tanabe T. Treatment of peri-implantitis around TiUnite-surface implants using Er:YAG laser microexplosions. Int J Periodontics Restorative Dent. 2013 Jan-Feb;33(1):21-30. doi: 10.11607/prd.1593.'}, {'pmid': '38147180', 'type': 'DERIVED', 'citation': 'Wang CW, Di Gianfilippo R, Kaciroti N, Ou A, Feng SW, Wang HL. Stability of peri-implantitis surgical reconstructive therapy-a (> 2 years) follow-up of a randomized clinical trial. Clin Oral Investig. 2023 Dec 26;28(1):30. doi: 10.1007/s00784-023-05457-6.'}, {'pmid': '32761810', 'type': 'DERIVED', 'citation': 'Wang CW, Ashnagar S, Gianfilippo RD, Arnett M, Kinney J, Wang HL. Laser-assisted regenerative surgical therapy for peri-implantitis: A randomized controlled clinical trial. J Periodontol. 2021 Mar;92(3):378-388. doi: 10.1002/JPER.20-0040. Epub 2020 Aug 25.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate if using Erbium-doped yttrium aluminium garnet laser, Erbium YAG laser (Er:YAG) laser could have adjunctive benefits to the conventional standard mechanical debridement to ablate the infected tissue around the dental implant and detoxify the contaminated implant surface for resolving peri-implant infection and enhance bone regeneration of peri-implant defects.', 'detailedDescription': 'The purpose of the study is to evaluate if using Er:YAG laser could have adjunctive benefits to the conventional standard mechanical debridement to ablate the infected tissue around the dental implant and detoxify the contaminated implant surface for resolving peri-implant infection and enhance bone regeneration of peri-implant defects.\n\nThis study involves one center and a double-blinded randomized controlled clinical trial is planned. Twenty-four adult patients in the need of surgical treatment due to peri-implantitis will be included. Six visits are needed for each patient including a 24 week follow-up visit.\n\nSpecific Aim 1: To compare the clinical benefit of Er:YAG laser-assisted peri-implant defect debridement and surface detoxification with conventional mechanical debridement for regenerative therapy\n\nSpecific Aim 2: To evaluate whether Er:YAG laser-assisted regenerative surgical therapy can decrease bacterial load and alter microbial profile\n\nSpecific Aim 3: To analyze whether Er:YAG laser-assisted regenerative surgical therapy can impact the molecular profile of the peri-implant crevicular fluid (PICF) and the stability of the treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects, aged 18 - 85 years\n* Physical status according to the American Society of Anesthesiologists (ASA) I or II, which includes patients who are systemically healthy or suffer under mild to moderate, but well controlled systemic diseases.\n* Subjects having a minimum of 1 dental implant with peri-implantitis.\n* Dental implants with peri-implantitis ≥ 2 threads exposed (infrabony defect) identified on the radiograph and pocket probing depth (PPD) ≥ 5mm, with bleeding on probing (BOP) and/or suppuration (pus)\n* The implants are in function for at least 6 months\n* Only rough surface implant will be included in this study\n\nExclusion Criteria:\n\n* Long-term use of antibiotics \\> 2 weeks in the past two months\n* Obvious malpositioning of the dental implants\n* Subjects taking medications known to modify bone metabolism (such as bisphosphonates, corticosteroids, Hormone replacement therapy for menopausal women, parathyroid hormone, Denosumab, strontium ranelate)\n* Pregnant females or those planning to become pregnant\n* Subjects with a history of major diseases, oral cancer, sepsis or those having adverse outcomes to oral procedures in the past, will be excluded\n* Mobility of dental implants\n* History of alcoholism or drug abuse\n* Current smokers\n* Diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes (HbA1c \\>8)\n* Uncontrolled systemic disease or condition known to alter bone metabolism, like Osteoporosis, Osteopenia, Hyperparathyroidism, Paget's disease\n\nPremature Exclusion Criteria:\n\n* The researcher believes that it is not the best interest of the subject to stay in the study\n* If the subject becomes ineligible to participate based on the exclusion criteria\n* If the subject's medical condition requires interventions which preclude involvement in the study (radiation therapy, chemotherapy, etc)\n* If the subject does not follow study related instructions\n* The study is suspended or canceled."}, 'identificationModule': {'nctId': 'NCT03127228', 'briefTitle': 'Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'HUM00124386'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard mechanical debridement', 'description': 'Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with dental scalers.', 'interventionNames': ['Other: Standard mechanical debridement']}, {'type': 'EXPERIMENTAL', 'label': 'Er:YAG laser-assisted debridement', 'description': 'Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with the aid of the laser treatment.', 'interventionNames': ['Other: Standard mechanical debridement', 'Device: Er:YAG laser-assisted debridement']}], 'interventions': [{'name': 'Standard mechanical debridement', 'type': 'OTHER', 'description': 'Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy', 'armGroupLabels': ['Er:YAG laser-assisted debridement', 'Standard mechanical debridement']}, {'name': 'Er:YAG laser-assisted debridement', 'type': 'DEVICE', 'description': 'Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with the aid of the laser prior to bone grafting regenerative therapy', 'armGroupLabels': ['Er:YAG laser-assisted debridement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48104', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan School of Dentistry', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Jeff (Chin-Wei) Wang, DDS, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Periodontics and Oral Medicine University of Michigan School of Dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Morita J USA', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Chin-Wei Wang', 'investigatorAffiliation': 'University of Michigan'}}}}