Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT06337435
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2024-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Using Multi-looped Lingual Retainer to Relief Anterior Mandibular Crowding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-22', 'studyFirstSubmitDate': '2024-03-15', 'studyFirstSubmitQcDate': '2024-03-22', 'lastUpdatePostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The improvement of lower incisors irregularity using Little Irregularity Index.', 'timeFrame': 'follow-up three to six months', 'description': 'using multi-looped for relief crowding, the digital model analysis will be used to calculate the amount of irregularity by using Little Irregularity Index .the measurement will be done on 3-shape software.'}], 'secondaryOutcomes': [{'measure': 'The stability of lower incisor positioning after ending treatment', 'timeFrame': 'after 1-3 months', 'description': 'using multi-looped as a retainer for stability to prevent the relapse after end treatment and the amount of lower incisor irregularity will be evaluated on scanned post-treatment digital models and measured on the 3-shape software.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Crowding of Anterior Mandibular Teeth']}, 'descriptionModule': {'briefSummary': 'this study aim to evaluate the multi-looped lingual retainer activated by a new method to relief the anterior crowding', 'detailedDescription': "1. patients preparation( photo- impression- x-ray- scan the lower cast to calculate the crowding )\n2. The multi-looped lingual retainer was fabricated on the patient's lower cast\n3. The lingual surfaces of teeth were etched with 35% phosphoric acid for 20 seconds The multi-looped lingual retainer was activated in the new way (Kattan method ) by tightening a steel ligature wire 0.010 inches, to the reinforcement 0.020-inch stainless steel arch-wire.\n4. the bonding agent was applied on such surfaces after a good isolation and was light-cured for 20 seconds.\n5. A flowable composite resin was applied. After checking its fit on the surface of the teeth, The lingual wire was bonded with a drop of flowable composite resin and was light-cured for 20 seconds.\n6. follow-up the patients \\* Outcomes: The improvement of lower incisors irregularity using Little Irregularity Index."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with mild to moderate crowding', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male and female patients, the ages of 16 to 25, the patients having class I canine with mild to moderate lower incisors crowding\n* good oral hygiene.\n\nExclusion Criteria:\n\n* Facial trauma, Oral habits such as onychophagia, pen biting, and tooth mobility.'}, 'identificationModule': {'nctId': 'NCT06337435', 'briefTitle': 'Using Multi-looped Lingual Retainer to Relief Anterior Mandibular Crowding', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Ability of the Multi-Looped Lingual Retainer Activated by A New Method to Align Lower Incisor Crowding', 'orgStudyIdInfo': {'id': '8223'}}, 'armsInterventionsModule': {'interventions': [{'name': 'multi-looped wire', 'type': 'OTHER', 'description': 'using multi-looped wire as a retainer'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'faculty of dentistry Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'bassel mouafak alhawash, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'bassel.alhawash@dentistry.cu.edu.eg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'master degree faculty Cairo university', 'investigatorFullName': 'Basel Mouafak Mohamed Alhawash', 'investigatorAffiliation': 'Cairo University'}}}}