Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2025-12-29 @ 8:01 PM
Study NCT ID:
NCT03407261
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2018-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OHRQoL and Accelerated Orthodontics With Micro-osteoperforations
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': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-22', 'studyFirstSubmitDate': '2018-01-16', 'studyFirstSubmitQcDate': '2018-01-22', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparision of OHRQoL between groups - OHIP-14A', 'timeFrame': '4 days', 'description': 'comparision of OHIP-14A results between groups after appointment for anterior retraction: The sum of the numeric scores for each participant in all 14 items, with a maximum score of 56 (4x14);'}, {'measure': 'Comparision of OHRQoL between groups - 7 domains', 'timeFrame': '4 days', 'description': 'comparision of each OHIP-14 domain results between groups after appointment for anterior retraction: To evaluate which domains had the most impact during the trial, the answers for each question were combined as pairs and summed for statistical analysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malocclusion']}, 'descriptionModule': {'briefSummary': 'OHRQoL assessment using OHIP-14 between sliding anterior retraction with self-ligating brackets and micro-osteoperforations for accelerated orthodontics in orthognathic surgery patients who were assigned for pre-molar extraction and decompensation', 'detailedDescription': "Our patients are participants in a randomized clinical trial, an ongoing study about the effectiveness of micro-osteoperforations to accelerate tooth movement. The study sample consisted of 22 consecutive subjects - 12 females and 10 males - between the ages of 18 and 35, who were selected for ortho-surgical treatment and pre-molar extraction assigned for decompensation. The participants were randomly allocated to two groups: control (anterior retraction was performed using implant-assisted sliding mechanics with self-ligating brackets) and experimental (micro-osteoperforations were performed in the activation appointments for anterior retraction using implant-assisted sliding mechanics). For immediate and follow-up assessment of patients' perceptions, comparing regular orthodontic activation and activation with Accelerated Orthodontics, subjects were asked to complete an electronic questionnaire OHIP-14, to assess the participants' comfort level, experiences, and QoL impact."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* maxillomandibular discrepancy indicative for orthognathic surgery, no previous dental extractions, good oral and general health, non-smokers, and no use of systemic corticosteroids or biphosphonates\n\nExclusion Criteria:\n\n* any tooth absence/previous tooth extraction'}, 'identificationModule': {'nctId': 'NCT03407261', 'briefTitle': 'OHRQoL and Accelerated Orthodontics With Micro-osteoperforations', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'OHRQoL Assessment Between Sliding Anterior Retraction and Micro-osteoperforations for Accelerated Orthodontics in Patients Who Were Assigned for Pre-molar Extraction and Decompensation', 'orgStudyIdInfo': {'id': 'Fattori3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Micro-osteoperforations', 'description': 'Minimally invasive micro-osteoperforations procedure used to achieve accelerated orthodontic tooth movement. Topical and local anesthetic will be delivered in the area to be treated in accordance with standard practice', 'interventionNames': ['Procedure: micro-osteoperforations']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Anterior retraction after premolars extraction will be done conventionally (sliding mechanics)'}], 'interventions': [{'name': 'micro-osteoperforations', 'type': 'PROCEDURE', 'description': 'Three vertical micro-osteoperforations, using Excellerator, in the buccal extracted site were executed following the aseptic procedure and local anesthesia', 'armGroupLabels': ['Micro-osteoperforations']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05508000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'FOUSP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student', 'investigatorFullName': 'LIANA FATTORI ABATI', 'investigatorAffiliation': 'University of Sao Paulo'}}}}