Ignite Creation Date:
2025-12-24 @ 9:35 PM
Ignite Modification Date:
2025-12-31 @ 3:29 AM
Study NCT ID:
NCT06873932
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-17
First Post:
2025-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Orthodontic Tooth Movement Using Beveled and Conventional Attachments in Aligners
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008310', 'term': 'Malocclusion'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 51}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2025-03-07', 'studyFirstSubmitQcDate': '2025-03-07', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the efficacy of dental movement using beveled and conventional attachments', 'timeFrame': 'From enrollment to the end of treatment, not exceeding 24 months.', 'description': 'Difference between the planned movement and the achieved movement, and the percentage of orthodontic dental movement achieved.'}], 'secondaryOutcomes': [{'measure': 'To measure dental movements achieved with the treatment.', 'timeFrame': 'From enrollment to the end of treatment, not exceeding 24 months.', 'description': 'To measure the horizontal, vertical, and rotational dental movements achieved with the treatment'}, {'measure': 'Measure the transverse dental changes achieved.', 'timeFrame': 'From enrollment to the end of treatment, not exceeding 24 months.', 'description': 'Transverse dental changes will be analyzed by comparing pre-treatment and post-treatment digital dental scans.'}, {'measure': 'To assess participant satisfaction throughout the treatment.', 'timeFrame': 'From enrollment to the end of treatment, not exceeding 24 months.', 'description': 'Participant satisfaction will be recorded pre-treatment, during follow-up, and post-treatment. In this study, oral health-related quality of life will be assessed through the OHIP-14 (Oral Health Impact Profile-14) questionnaire as a measure of participant satisfaction with the treatment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malocclusion', 'Tooth Movement Techniques']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the efficacy of tooth movement using beveled attachments and conventional attachments. The sample will be consecutively selected, comprising participants seeking orthodontic treatment in a private dental office within the recruitment period (from ethics committee approval to July 2027). Participants will be selected and randomized using a split-mouth study design. Groups will be divided into rectangular and beveled attachments, each further subdivided into subgroups for horizontal movements (Group H), vertical movements (Group V), and rotations (Group R), with 20 teeth/attachments per group, totaling a sample of 120 teeth/attachments. Digital study models will be obtained before the start of treatment and immediately after its completion. Additionally, clinical intraoral and extraoral photographs will be taken (pre- and post-treatment). Measurements will be collected from the initial and final digital models to determine the magnitude and direction of movements resulting from treatment. Descriptive statistics will be calculated for each type of dental movement evaluated. Paired tests will be conducted due to the split-mouth design. Correlation tests will be applied if necessary.', 'detailedDescription': "Participant recruitment will take place after approval by the Research Ethics Committee until July 2027. The consultations will occur in a private clinic in Curitiba - PR, Brazil.\n\nParticipants will be selected and randomized according to the split-mouth study design. Teeth on each side will have different attachment configurations to aid orthodontic aligner movements. One side will use rectangular attachments, and the other side will use beveled attachments. Groups will be divided as follows:\n\nGroup H: 20 teeth/attachments with horizontal displacements (parallel to the occlusal plane) including tipping or mesio-distal translation - premolars and molars.\n\nGroup V: 20 teeth/attachments with vertical displacements (extrusion and intrusion) - incisors.\n\nGroup R: 20 teeth/attachments with mesio-distal rotations - canines and premolars.\n\nDigital study models (intraoral scanner) will be obtained before and after treatment. These intraoral scans will be analyzed alongside the planned movement models generated by the orthodontic treatment planning software.\n\nTreatment efficacy will be analyzed using tooth-tracking methodology in Geomagic Control X, measuring the differences between planned and achieved movements and calculating the percentage of achieved orthodontic tooth movement.\n\nAdditionally, pre- and post-treatment clinical photographs will be taken:\n\nIntraoral:\n\nFrontal in occlusion; Right and left lateral views in occlusion; Occlusal views of upper and lower arches.\n\nExtraoral:\n\nFrontal with lips at rest; Frontal with a wide smile; Profile with lips at rest. All participants will receive orthodontic aligner treatment supervised by a qualified professional capable of providing relevant care under clinical trial conditions. Diagnosis, movement planning, and therapy monitoring procedures (e.g., aligner replacement frequency) for each individual will be established by the researcher, respecting the manufacturer's specified instructions.\n\nThe sample size was 30 participants will be recruited, totaling a sample of 120 teeth/attachments.\n\nParticipant satisfaction will be recorded pre-treatment, during follow-up, and post-treatment. In this study, oral health-related quality of life will be assessed through the OHIP-14 (Oral Health Impact Profile-14) questionnaire as a measure of participant satisfaction with the treatment.\n\nInitial and final digital models will be imported using software, where measurements will be taken to identify the magnitude and direction of movements resulting from treatment with different attachment types:\n\nHorizontal displacements (parallel to the occlusal plane) including tipping or mesio-distal translation - premolars and molars.\n\nVertical displacements (extrusion and intrusion) - incisors. Mesio-distal rotations - canines and premolars.\n\nDescriptive statistics will be calculated for each type of tooth movement evaluated and described by mean, standard deviation, median, quartiles, minimum, and maximum. Paired tests will be conducted due to the split-mouth design. Correlation tests will also be applied if necessary."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults (18+ years) with permanent dentition\n* Candidates for aligner-based orthodontic treatment\n* Require bilateral tooth movements (e.g., extrusion, intrusion, rotation, tipping, mesiodistal translation)\n* Provide written informed consent\n\nExclusion Criteria:\n\n* Contraindications to aligner use (e.g., manufacturer's guidelines)\n* Poor oral hygiene, active periodontal disease, or TMJ disorders\n* Allergies to aligner materials (e.g., polyurethane, PETG)"}, 'identificationModule': {'nctId': 'NCT06873932', 'briefTitle': 'Efficacy of Orthodontic Tooth Movement Using Beveled and Conventional Attachments in Aligners', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neodent'}, 'officialTitle': 'Efficacy of Orthodontic Tooth Movement Using Beveled and Conventional Attachments in Aligners: a Randomized Split-Mouth Clinical Trial', 'orgStudyIdInfo': {'id': 'CC.2024.Attachments'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm: Beveled attachments', 'description': 'The patients will receive beveled attachments on one side of the jaws', 'interventionNames': ['Device: Arm 1: Beveled Attachments']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rectangular Attachments', 'description': 'The patients will receive rectangular attachments on one side of the jaws', 'interventionNames': ['Device: Conventional Rectangular Attachments']}], 'interventions': [{'name': 'Arm 1: Beveled Attachments', 'type': 'DEVICE', 'description': 'Beveled attachments applied to 20 teeth in each subgroup (horizontal, vertical, and rotational movements).', 'armGroupLabels': ['Arm: Beveled attachments']}, {'name': 'Conventional Rectangular Attachments', 'type': 'DEVICE', 'description': 'Conventional rectangular attachments applied to 20 teeth in each subgroup (horizontal, vertical, and rotational movements).', 'armGroupLabels': ['Rectangular Attachments']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81270-200', 'city': 'Curitiba', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Private orthodontic clinic', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neodent', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}