Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-29 @ 2:40 PM
Study NCT ID:
NCT04041804
Status:
UNKNOWN
Last Update Posted:
2020-09-02
First Post:
2019-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Activation Intervals Effects on Non-surgical Maxillary Expansion in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010155', 'term': 'Palatal Expansion Technique'}], 'ancestors': [{'id': 'D009971', 'term': 'Orthodontics, Corrective'}, {'id': 'D009970', 'term': 'Orthodontics'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-31', 'studyFirstSubmitDate': '2019-02-13', 'studyFirstSubmitQcDate': '2019-07-31', 'lastUpdatePostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transversal distance between upper canines, first premolars and upper first molars', 'timeFrame': 'Change from baseline to 6 months', 'description': 'Distance between mesial fosa of each upper canines, first premolars and distance between central fosa of each upper first molars'}, {'measure': 'Posterior teeth buccal inclination', 'timeFrame': 'Change from baseline to 6 months', 'description': 'Measure in CBCT in a coronal slice between the palatal plane and the dental axis'}, {'measure': 'Buccal bone area evaluation', 'timeFrame': 'Change from baseline to 6 months', 'description': 'Measure in CBCT in a coronal slice, thickness of the buccal bone in upper first premolars and upper first molars'}], 'secondaryOutcomes': [{'measure': 'Bleeding on probing (BP)', 'timeFrame': 'Change from baseline to 6 months', 'description': "It's going to be measured by clinical exam with a periodontal probe and it is verified the presence of bleeding and it will be register as 0= No bleeding and 1= bleeding"}, {'measure': 'Evaluation of the perception of pain by the patient (VAS)', 'timeFrame': 'Change from baseline to 6 months', 'description': 'Pain visual analogue scale (AVS) - from 0 to 10 points, Higher values represent more pain perception by the participant'}, {'measure': 'Probing depth (PD)', 'timeFrame': 'Change from baseline to 6 months', 'description': "Probing depth (PD): It's going to be measured by clinical exam with a periodontal probe and it is measured from the gingival margin to the bottom of the groove. It is considered the presence of a periodontal pocket when the depth of the groove is greater than 3mm."}, {'measure': 'Clinical attachment level (CAL)', 'timeFrame': 'Change from baseline to 6 months', 'description': 'Linear measurement in mm. It is constructed from the relationship between probe depth (PD) and the measurement in millimeters from the cement enamel junction (CEJ) to the gingival margin'}, {'measure': 'Soft tissue recession (STR)', 'timeFrame': 'Change from baseline to 6 months', 'description': 'Soft tissue apical migration of the cement-enamel junction, it is going to classified as:\n\nClass I: Retraction of marginal tissue that does not extend to the mucogingival junction without loss of interdental tissue.\n\nClass II: Retraction of marginal tissue that extends to the mucogingival junction, or beyond it, there is no loss of bone, nor of interdental soft tissue.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Palatal Expansion Technique', 'Cone-Beam Computed Tomography'], 'conditions': ['Maxillary Anomaly']}, 'descriptionModule': {'briefSummary': 'OBJECTIVE: To evaluate the effects of different time intervals activations on the non-surgical maxillary expansion in adults. Methods: This study will include two groups, 10 adult patients each (mean age 20-35) with maxillary transverse deficiency and unilateral or bilateral crossbite. In the first group, the expansion is going to be activated every four days. In the second group, activation will occur every eight days. The primary outcomes are transverse dimension, the buccal cortical bone formation, and the upper premolar and molar labial inclination. Dentoalveolar changes will be evaluated using CBCT images and digital models.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* Presence of transverse maxillary deficiency unilateral or bilateral in which the maxillary cusps of at least two premolars and/or maxillary molars occluded on the central fossa of the antagonist's teeth\n* The needs of maxillary expansion for the correction of their malocclusion\n* Age range from 20 to 35\n* Non-gingivitis or untreated caries at the start of orthodontic treatment\n* Probing depth less than 4mm across the entire dentition\n* Gingival index ≤ 1\n* Plaque index ≤ 1\n\nExclusion Criteria:\n\n* Increased Monson curve\n* Patients with systemic disease\n* Patients with congenital anomalies\n* Medicated patients (long term use of antibiotics, Phenytoin, cyclosporine, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers)\n* Pregnancy\n* Poor oral hygiene for more than two visits\n* Radiographic evidence of moderate to severe bone loss\n* Current periodontal disease\n* Patients who smoke\n* Individuals with inadequately treated endodontic problems in the study area."}, 'identificationModule': {'nctId': 'NCT04041804', 'briefTitle': 'Activation Intervals Effects on Non-surgical Maxillary Expansion in Adults', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Universitaria CIEO'}, 'officialTitle': 'Activation Intervals Effects on Non-surgical Semi-rapid Maxillary Expansion in Adults', 'orgStudyIdInfo': {'id': '044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Every week RPE activation', 'description': 'Non-surgical semi-rapid maxillary expansion (SRME) with the time intervals activation every week until getting the require expansion needed', 'interventionNames': ['Procedure: semirapid maxillary expansion (SRME)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Every four days RPE activation', 'description': 'Non-surgical semi-rapid maxillary expansion (SRME) with the time intervals activation every four days until getting the require expansion needed', 'interventionNames': ['Procedure: semirapid maxillary expansion (SRME)']}], 'interventions': [{'name': 'semirapid maxillary expansion (SRME)', 'type': 'PROCEDURE', 'otherNames': ['Maxillary Expansion'], 'description': 'A Banded Hyrax is going to be used in order to provide an increase in the maxillary transverse dimension', 'armGroupLabels': ['Every four days RPE activation', 'Every week RPE activation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110111', 'city': 'Bogotá', 'state': 'DC', 'status': 'RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Sonia P Plaza, Msc', 'role': 'CONTACT', 'email': 'sp.plaza@unicieo.edu.co', 'phone': '573183973032'}, {'name': 'Elsa Arango, DDs', 'role': 'CONTACT', 'email': 'evarango8@gmail.com', 'phone': '573102857936'}, {'name': 'Claudia Ramirez, DDs', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Fundación Universitaria UniCIEO', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}], 'centralContacts': [{'name': 'Sonia Plaza, MSD', 'role': 'CONTACT', 'email': 'orthoplaza@hotmail.com', 'phone': '573183973032'}], 'overallOfficials': [{'name': 'Elsa Arango, DDS', 'role': 'STUDY_CHAIR', 'affiliation': 'Fundación Universitaria UniCIEO'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Universitaria CIEO', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Research Orthodontic Department, Principal Investigator.', 'investigatorFullName': 'Sonia Patricia Plaza', 'investigatorAffiliation': 'Fundación Universitaria CIEO'}}}}