Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-02-21 @ 9:48 PM
Study NCT ID:
NCT04266769
Status:
COMPLETED
Last Update Posted:
2024-11-27
First Post:
2020-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Precision Orthodontics: A Comparison of Custom vs Traditional Bracket Treatment Efficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008310', 'term': 'Malocclusion'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kelsey@lightforceortho.com', 'phone': '7329775646', 'title': 'Kelsey Fafara', 'organization': 'LightForce Orthodontics'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Patients were evaluated for any adverse events over their treatment, an expected average of 2 years. However, two patients had treatment times over 2 years with the maximum being under 4 years/', 'eventGroups': [{'id': 'EG000', 'title': 'Patients With Malocclusion', 'description': 'LightForce Orthodontic System: The LightForce Orthodontic System is a a digital treatment planning platform and patient-specific 3D printed polycrystalline alumina brackets for the treatment of malocclusion', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Length of Bonding Appointment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Malocclusion', 'description': 'LightForce Orthodontic System: The LightForce Orthodontic System is a a digital treatment planning platform and patient-specific 3D printed polycrystalline alumina brackets for the treatment of malocclusion'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'spread': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Debonded Brackets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Malocclusion', 'description': 'LightForce Orthodontic System: The LightForce Orthodontic System is a a digital treatment planning platform and patient-specific 3D printed polycrystalline alumina brackets for the treatment of malocclusion'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'spread': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'approximately 2 years', 'unitOfMeasure': 'number of brackets', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "One patient did not complete treatment as they moved out of town and no longer went to the study's orthodontists."}, {'type': 'PRIMARY', 'title': 'Length of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Malocclusion', 'description': 'LightForce Orthodontic System: The LightForce Orthodontic System is a a digital treatment planning platform and patient-specific 3D printed polycrystalline alumina brackets for the treatment of malocclusion'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'spread': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'approximately 2 years', 'unitOfMeasure': 'months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "One patient did not complete treatment as they moved out of town and no longer went to the study's orthodontists."}, {'type': 'PRIMARY', 'title': 'Length of Debond Appointment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Malocclusion', 'description': 'LightForce Orthodontic System: The LightForce Orthodontic System is a a digital treatment planning platform and patient-specific 3D printed polycrystalline alumina brackets for the treatment of malocclusion'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "One patient did not complete treatment as they moved out of town and no longer went to the study's orthodontists."}, {'type': 'PRIMARY', 'title': 'Length of Time to Achieve Leveling and Aligning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Malocclusion', 'description': 'LightForce Orthodontic System: The LightForce Orthodontic System is a a digital treatment planning platform and patient-specific 3D printed polycrystalline alumina brackets for the treatment of malocclusion'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'spread': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "One patient did not complete treatment as they moved out of town and no longer went to the study's orthodontists."}, {'type': 'PRIMARY', 'title': 'Number of Unscheduled Appointments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Malocclusion', 'description': 'LightForce Orthodontic System: The LightForce Orthodontic System is a a digital treatment planning platform and patient-specific 3D printed polycrystalline alumina brackets for the treatment of malocclusion'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'spread': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'number of appointments', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "One patient did not complete treatment as they moved out of town and no longer went to the study's orthodontists."}, {'type': 'PRIMARY', 'title': 'Number of Repositioned Brackets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Malocclusion', 'description': 'LightForce Orthodontic System: The LightForce Orthodontic System is a a digital treatment planning platform and patient-specific 3D printed polycrystalline alumina brackets for the treatment of malocclusion'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'spread': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'number of brackets', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "One patient did not complete treatment as they moved out of town and no longer went to the study's orthodontists."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients With Malocclusion', 'description': 'LightForce Orthodontic System: The LightForce Orthodontic System is a a digital treatment planning platform and patient-specific 3D printed polycrystalline alumina brackets for the treatment of malocclusion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients With Malocclusion', 'description': 'LightForce Orthodontic System: The LightForce Orthodontic System is a a digital treatment planning platform and patient-specific 3D printed polycrystalline alumina brackets for the treatment of malocclusion'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Time to Bond', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Data was not collected for patients at a baseline', 'unitOfMeasure': 'Minutes', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data was not collected for patients at a baseline'}, {'title': 'Length of treatment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Data was not collected for patients at a baseline', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data was not collected for patients at a baseline'}, {'title': 'length of debonding appointment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Data was not collected for patients at a baseline', 'unitOfMeasure': 'Minutes', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data was not collected for patients at a baseline'}, {'title': 'length of time to achieve level and align', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Data was not collected for patients at a baseline', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data was not collected for patients at a baseline'}, {'title': 'number of unscheduled appointments', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'number of brackets', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data was not collected for patients at a baseline'}, {'title': 'Number of repositioned brackets', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'number of brackets', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data was not collected for patients at a baseline'}], 'populationDescription': 'Baseline metrics were not taken for the study population.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-12-17', 'size': 176998, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-11T16:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-04', 'studyFirstSubmitDate': '2020-02-10', 'resultsFirstSubmitDate': '2024-01-11', 'studyFirstSubmitQcDate': '2020-02-10', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-04', 'studyFirstPostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of Bonding Appointment', 'timeFrame': '1 day'}, {'measure': 'Number of Debonded Brackets', 'timeFrame': 'approximately 2 years'}, {'measure': 'Length of Treatment', 'timeFrame': 'approximately 2 years'}, {'measure': 'Length of Debond Appointment', 'timeFrame': '1 day'}, {'measure': 'Length of Time to Achieve Leveling and Aligning', 'timeFrame': '2 years'}, {'measure': 'Number of Unscheduled Appointments', 'timeFrame': '2 years'}, {'measure': 'Number of Repositioned Brackets', 'timeFrame': '2 years'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Dental Malocclusion']}, 'descriptionModule': {'briefSummary': 'This investigational testing aims to target multiple investigations sites to examine treatment efficiency metrics using a completely digital and patient-specific bracket treatment system for the correction of malocclusions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All subjects must be healthy and between the ages of 10 and 65.\n* Eruption of all permanent teeth excluding second and third molars\n* Sufficient labial tooth surface for bonding\n* No more than one tooth missing from a single arch quadrant\n* No existing molar tubes or bands\n\nExclusion Criteria:\n\n* Presence of systemic diseases, cleft lip and palate, craniofacial anomalies, syndromes affecting bone or teeth, impacted teeth (excluding 3rd molars), and tumors of the parathyroid gland\n* Presence of bridges or implants\n* Cases requiring orthognathic surgery\n* Significant periodontal disease\n* Intake of drugs affecting tooth movement or bone formation (chronic use of Non-Steroidal Anti-Inflammatory Drugs, bisphosphonates, levothyroxine, or teriparatide drug class)\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04266769', 'briefTitle': 'Precision Orthodontics: A Comparison of Custom vs Traditional Bracket Treatment Efficiency', 'organization': {'class': 'INDUSTRY', 'fullName': 'LightForce Orthodontics'}, 'officialTitle': 'Precision Orthodontics: A Comparison of Custom vs Traditional Bracket Treatment Efficiency', 'orgStudyIdInfo': {'id': 'Pro00040384'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with Malocclusion', 'interventionNames': ['Device: LightForce Orthodontic System']}], 'interventions': [{'name': 'LightForce Orthodontic System', 'type': 'DEVICE', 'description': 'The LightForce Orthodontic System is a a digital treatment planning platform and patient-specific 3D printed polycrystalline alumina brackets for the treatment of malocclusion', 'armGroupLabels': ['Patients with Malocclusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L6A 0A9', 'city': 'Maple', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Walt Orthodontics', 'geoPoint': {'lat': 43.32389, 'lon': -79.81333}}], 'overallOfficials': [{'name': 'Kelsey Fafara, BS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LightForce Orthodontics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LightForce Orthodontics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}