Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT06032702
Status:
UNKNOWN
Last Update Posted:
2023-09-13
First Post:
2023-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of 3 Week vs 6 Week Orthodontic Appointment Intervals on Teeth Alignment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-05', 'studyFirstSubmitDate': '2023-09-05', 'studyFirstSubmitQcDate': '2023-09-05', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'alignment efficiency and interappointment interval', 'timeFrame': "Time frame for measurement of (Little's Irregularity Index) was every 6th week over a period of 6 months, giving a total of 5 measurements", 'description': "Changes in Little's Irregularity Index between arm 1 and arm 2 and comparison of both interventions."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orthodontic Tooth Movement', 'Tooth Alignment']}, 'descriptionModule': {'briefSummary': 'Effect of 3 week vs 6 week orthodontic appointment intervals on teeth alignment in patients with moderate to severe dental crowding: a randomized clinical trial.\n\nThere is still inconclusive evidence about the orthodontics treatment duration and interappointment interval.', 'detailedDescription': 'Patients with moderate to severe crowding will be divided randomly into two groups (Group A and Group B). Group A includes patients with an interval of 3 weeks between their appointments while Group B includes the patients with an interval of 6 weeks between their appointments.\n\n1. To determine the mean changes in the tooth irregularity index of a patient with mild to moderate crowding activated every 3rd week\n2. To determine the mean changes in the tooth irregularity index of a patient with mild to moderate crowding activated every 6th week\n3. To compare the difference between the two modalities in percentage'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged 16-30\n* Little's irregularity index from 5mm to 12mm\n* Healthy periodontium\n* No systemic disease\n* Patients giving consent for inclusion\n\nExclusion Criteria:\n\n* Little's irregularity index less than 5mm and more than 12mm\n* Blocked out incisors needing push coil\n* Ankylosed teeth\n* Active periodontal disease\n* Systemic bone disease\n* Non-compliant patients\n* Patients with frequent breakages"}, 'identificationModule': {'nctId': 'NCT06032702', 'briefTitle': 'Effect of 3 Week vs 6 Week Orthodontic Appointment Intervals on Teeth Alignment', 'organization': {'class': 'OTHER', 'fullName': 'Bkahtawar Amin Medical and Dental College Multan'}, 'officialTitle': 'Effect of 3 Week vs 6 Week Orthodontic Appointment Intervals on Teeth Alignment in Patients With Moderate to Severe Dental Crowding: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'BAMDC 0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3 week interval', 'description': '3 week orthodontic interappointment interval', 'interventionNames': ['Procedure: tooth alignment']}, {'type': 'EXPERIMENTAL', 'label': '6 week interval', 'description': '6 week orthodontic interappointment interval', 'interventionNames': ['Procedure: tooth alignment']}], 'interventions': [{'name': 'tooth alignment', 'type': 'PROCEDURE', 'description': "Alignment will be assessed by Little's Irregularity Index", 'armGroupLabels': ['3 week interval', '6 week interval']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66000', 'city': 'Multan', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Waqar Jeelani, BDS,FCPS, MOrth-Edin UK', 'role': 'CONTACT', 'email': 'wjeelani@gmail.com', 'phone': '00923457936578'}, {'name': 'Maheen Ahmed, BDS,FCPS, MOrth-Edin UK', 'role': 'CONTACT', 'email': 'a_maheen01@hotmail.com', 'phone': '00923002799443'}], 'facility': 'Bakhtawar Amin Medical And Dental College', 'geoPoint': {'lat': 30.19679, 'lon': 71.47824}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bkahtawar Amin Medical and Dental College Multan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}