Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-01-04 @ 9:40 PM
Study NCT ID:
NCT02290158
Status:
COMPLETED
Last Update Posted:
2015-12-08
First Post:
2014-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Finishing Protocol Implementation in Orthodontic Patients
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-07', 'studyFirstSubmitDate': '2014-10-26', 'studyFirstSubmitQcDate': '2014-11-08', 'lastUpdatePostDateStruct': {'date': '2015-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ABO-OGS Total Score', 'timeFrame': 'Until 7 days after orthodontic appliances are removed', 'description': 'Sum of 8 variables scores ( alignment, marginal ridge height, buccolingual inclination, overjet, interproximal contact, occlusal contacts, occlusal relationships, and root angulation ) 1: difference less than 1 mm, 2: difference between 1 and 2 mm, 3: difference bigger than 2 mm . Total score less than 20: Excellent , Total score between 20-30: Acceptable and Total Score: \\> 30 No acceptable'}], 'secondaryOutcomes': [{'measure': 'Line Smile', 'timeFrame': 'Until 7 days after orthodontic appliances are removed', 'description': 'Gingival exposure in smiling photo: High: More than 2 mm of gingival exposure, Media: between 2 and O mm of gingival exposure , Low: Less than clinical crown'}, {'measure': 'Arch Smile', 'timeFrame': 'Until 7 days after orthodontic appliances are re', 'description': 'Relationship between incisor borders and upper lower lip border in an smiling photo'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['treatment outcomes', 'Malocclusion/therapy'], 'conditions': ['Malocclusion']}, 'descriptionModule': {'briefSummary': "This study evaluates the effects of a finishing protocol in orthodontic outcomes using ABO-OGS scores. Patients who finish orthodontic treatment and fulfill the inclusion and exclusion criteria receive a treatment using a finishing protocol and their scores are compare with 40 patients who don't receive a finishing protocol", 'detailedDescription': 'The phase of finishing is the most demanding and detailed of all phases of the orthodontic treatment. American Board of Orthodontics- Objective Grading system is a detailed and objective method that evaluates the quality of the final outcome of orthodontic treatment. In order to evaluate and compare the effects of a protocol implementation on the ABO-OGS scores, standardize cast models and Pan X-Ray from by convenience patients of Orthodontic Postgraduate Program of University of Antioquia who finish orthodontic treatment and receive the protocol are digitized, eight variables are evaluate and ABO-OGS score is calculate. A comparison with 40 no-protocol ABO-OGS scores by convenience-selected patients is done. The protocol includes an educate residents program about finishing problems , an standardized clinical and X-ray assessment , brackets reposition and frequent clinical evaluation. The percentage of the protocol implementation is calculate in every patient and reliability test is make . The descriptive analysis and the ABO-OGS score comparison is done by Pearson or Spearman correlation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who finish orthodontic treatment by orthodontic criteria\n* Receive finishing protocol\n* Accept and sign inform consent\n* Records ( Panoramic Xray and cast models) taken immediately or 7 days after orthodontic appliances are remove\n\nExclusion Criteria:\n\n* Patients who don't accept being at the study\n* Bad quality records\n* Prosthodontic, periodontic and surgical needs treatment after orthodontic treatment"}, 'identificationModule': {'nctId': 'NCT02290158', 'briefTitle': 'Effects of a Finishing Protocol Implementation in Orthodontic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Antioquia'}, 'officialTitle': 'Effects of a Finishing Protocol Implementation on the American Board of Orthodontics - Objective Grading System Score in Patients of Orthodontic Postgraduate Program: A Quasiexperimental Clinical Trial', 'orgStudyIdInfo': {'id': 'BACAZA1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Orthodontic finishing', 'description': 'Patients receiving a complete orthodontic finishing protocol according to the ABO-OGS', 'interventionNames': ['Other: Finishing Protocol']}, {'type': 'NO_INTERVENTION', 'label': 'No orthodontic finishing', 'description': 'Patients receiving orthodontic treatment without the finishing protocol according to the ABO-OGS'}], 'interventions': [{'name': 'Finishing Protocol', 'type': 'OTHER', 'description': 'Students education, cast models and Panoramic X-ray assessment, brackets reposition and frequent clinical evaluation.', 'armGroupLabels': ['Orthodontic finishing']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Medellín', 'state': 'Antioquia', 'country': 'Colombia', 'facility': 'Uniersidad de Antioquia', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Antioquia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asociated Pofessor', 'investigatorFullName': 'Alvaro Carvajal', 'investigatorAffiliation': 'Universidad de Antioquia'}}}}