Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-29 @ 10:18 AM
Study NCT ID:
NCT01888666
Status:
COMPLETED
Last Update Posted:
2013-08-15
First Post:
2013-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Rapid and Slow Palatal Expansion: Evaluation of Periodontal Indices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'lastUpdateSubmitDate': '2013-08-14', 'studyFirstSubmitDate': '2013-02-04', 'studyFirstSubmitQcDate': '2013-06-25', 'lastUpdatePostDateStruct': {'date': '2013-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluation of periodontal health by probing pocket depth, PPD', 'timeFrame': 'Change from Baseline in probing pocket depth at 20 days and 5 months of active therapy', 'description': 'In the Group I (RPE), probing pocket depth were detected in three stages:\n\nT0, detected 7 days after the periodontal prophylaxis (at the beginning of the active orthodontic therapy) ; T1, detected after 20 days of active therapy; T2, detected after 5 months of retention therapy.\n\nIn the Group II, the collected data corresponded to:\n\nT0, detected 7 days after the periodontal prophylaxis; T1, detected during clinical control after 3 months of active therapy; T2, detected after 3 months of restraint. All measurements were performed by the same examiner.'}], 'secondaryOutcomes': [{'measure': 'valuation of periodontal health by plaque index, PI', 'timeFrame': 'Change from Baseline in plaque index at 20 days and 5 months of active therapy', 'description': 'In the Group I (RPE), plaque index were detected in three stages:\n\nT0, detected 7 days after the periodontal prophylaxis (at the beginning of the active orthodontic therapy) ; T1, detected after 20 days of active therapy; T2, detected after 5 months of retention therapy.\n\nIn the Group II, the collected data corresponded to:\n\nT0, detected 7 days after the periodontal prophylaxis; T1, detected during clinical control after 3 months of active therapy; T2, detected after 3 months of restraint. All measurements were performed by the same examiner.'}, {'measure': 'evaluation of periodontal health by papillary bleeding index, PBI', 'timeFrame': 'Change from Baseline in papillary bleeding index at 20 days and 5 months of active therapy', 'description': 'In the Group I (RPE), papillary bleeding index were detected in three stages:\n\nT0, detected 7 days after the periodontal prophylaxis (at the beginning of the active orthodontic therapy) ; T1, detected after 20 days of active therapy; T2, detected after 5 months of retention therapy.\n\nIn the Group II, the collected data corresponded to:\n\nT0, detected 7 days after the periodontal prophylaxis; T1, detected during clinical control after 3 months of active therapy; T2, detected after 3 months of restraint. All measurements were performed by the same examiner.'}]}, 'conditionsModule': {'conditions': ['Palatal Expansion Technique']}, 'descriptionModule': {'briefSummary': "The aim of this study is to evaluate the periodontal effects during rapid palatal expansion (RPE) or slow palatal expansion (SPE) and to compare them by means of periodontal indices, in order to establish the possible differences and advantages of one of these treatments in periodontal terms.\n\nMaterials and methods: 10 patients will selected and submitted to RPE treatment; other 10 patients will selected and submitted to SPE treatment. The patients will treated with the Haas appliance. In both the groups the periodontal clinical indices (plaque index, PI; papillary bleeding index, PBI; probing pocket depth, PPD) will collected three times during the treatment (before, during and at the end). All measurements will performed by the same examiner.\n\nA descriptive statistical analysis will conducted. The paired samples Student's T test will used to evaluate the intra-group differences between t1 and t2. The unpaired samples Student's T test will used to evaluate between groups differences at t1 and t2. The significance level will set at 95%."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "patients attending the division of orthodontics of Department MeSVA, University of L'Aquila, Italy", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* palate narrow\n* necessity of performing a expansion treatment\n\nExclusion Criteria:\n\n* dental disease'}, 'identificationModule': {'nctId': 'NCT01888666', 'briefTitle': 'Comparison Between Rapid and Slow Palatal Expansion: Evaluation of Periodontal Indices', 'organization': {'class': 'OTHER', 'fullName': "University of L'Aquila"}, 'orgStudyIdInfo': {'id': 'Tecc01/2013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'rapid palatal expansion (RPE) using the Haas appliance'}, {'label': 'slow palatal expansion (SPE)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '67100', 'city': 'L’Aquila', 'state': 'AQ', 'country': 'Italy', 'facility': "Dept. of Life, Health and Environmental Science, University of L'Aquila", 'geoPoint': {'lat': 42.35055, 'lon': 13.39954}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "University of L'Aquila", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Contract professor', 'investigatorFullName': 'Enrico Marchetti', 'investigatorAffiliation': "University of L'Aquila"}}}}