Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT05390320
Status:
COMPLETED
Last Update Posted:
2022-05-25
First Post:
2022-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dental and Periodontal Changes Following the Acceleration of Alignment of Crowded Lower Anterior Teeth Using a Surgical Technique
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077744', 'term': 'Orthodontic Appliances, Fixed'}], 'ancestors': [{'id': 'D009967', 'term': 'Orthodontic Appliances'}, {'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': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-20', 'studyFirstSubmitDate': '2022-05-20', 'studyFirstSubmitQcDate': '2022-05-20', 'lastUpdatePostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in Little's Index of Irregularity", 'timeFrame': 'T0: one day before the beginning of treatment; T1: after 1 month; T2: after 2 months; T3: after 4 months; T4: after 5 months; T5: at the end of the alignment stage which is expected within 5 - 6 months', 'description': 'The irregularity of the lower incisors is calculated by measuring the amount of deviations of the anatomic contact points between the six anterior teeth in the horizontal direction in mm, since the sum of these measurements represents the value of the index (Little, 1975).\n\nThe ordinary orthodontic treatment aims to keep this Index less than 1 mm at the end of treatment.'}, {'measure': 'Change in the inter-canine width', 'timeFrame': 'T0: One day before the beginning of treatment; T1: at the end of the alignment stage', 'description': 'The distance between the cusp tips of the lower canines. This variable will be measured on plaster models.'}, {'measure': 'Change in the inter-2nd premolar width', 'timeFrame': 'T0: One day before the beginning of treatment; T1: at the end of the alignment stage', 'description': 'The distance between the central fossae of the lower second premolars. This variable will be measured on plaster models.'}], 'secondaryOutcomes': [{'measure': 'Change in the Gingival index', 'timeFrame': 'T0: One day before the beginning of treatment; T1: at the end of the alignment stage', 'description': 'Measured by degrees at each tooth: (0) Normal gingival; (1) mild inflammation; (2) Moderate inflammation; (3) severe inflammation'}, {'measure': 'Change in the Plaque index', 'timeFrame': 'T0: One day before the beginning of treatment; T1: at the end of the alignment stage', 'description': 'Measured by degrees at each tooth: (0) No plaque; (1) thin plaque layer; (2) moderate plaque layer; (3) severe plaque along the gingival margin'}, {'measure': 'Change in the Papillary Bleeding Index', 'timeFrame': 'T0: One day before the beginning of treatment; T1: at the end of the alignment stage', 'description': 'Measured by the severity of any bleeding: (0) No bleeding; (1) a single discreet bleeding point; (2) several isolated bleeding points; (3) the interdental triangle fills with blood shortly after probing; (4) profuse bleeding occurs after probing.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PAOO', 'moderate crowding', 'gingival index', 'plaque index', 'papillary bleeding index'], 'conditions': ['Crowding, Tooth']}, 'referencesModule': {'references': [{'pmid': '24036771', 'type': 'BACKGROUND', 'citation': 'Yu H, Jiao F, Wang B, Shen SG. Piezoelectric decortication applied in periodontally accelerated osteogenic orthodontics. J Craniofac Surg. 2013;24(5):1750-2. doi: 10.1097/SCS.0b013e3182902c5a.'}, {'pmid': '25347045', 'type': 'BACKGROUND', 'citation': 'Wu J, Jiang JH, Xu L, Liang C, Bai Y, Zou W. A pilot clinical study of Class III surgical patients facilitated by improved accelerated osteogenic orthodontic treatments. Angle Orthod. 2015 Jul;85(4):616-24. doi: 10.2319/032414-220.1. Epub 2014 Oct 27.'}, {'pmid': '27903250', 'type': 'BACKGROUND', 'citation': 'Bahammam MA. Effectiveness of bovine-derived xenograft versus bioactive glass with periodontally accelerated osteogenic orthodontics in adults: a randomized, controlled clinical trial. BMC Oral Health. 2016 Nov 30;16(1):126. doi: 10.1186/s12903-016-0321-x.'}, {'pmid': '24455038', 'type': 'BACKGROUND', 'citation': 'Amit G, Jps K, Pankaj B, Suchinder S, Parul B. Periodontally accelerated osteogenic orthodontics (PAOO) - a review. J Clin Exp Dent. 2012 Dec 1;4(5):e292-6. doi: 10.4317/jced.50822. eCollection 2012 Dec 1.'}, {'pmid': '18533317', 'type': 'BACKGROUND', 'citation': 'Nowzari H, Yorita FK, Chang HC. Periodontally accelerated osteogenic orthodontics combined with autogenous bone grafting. Compend Contin Educ Dent. 2008 May;29(4):200-6; quiz 207, 218.'}]}, 'descriptionModule': {'briefSummary': 'Patients at the Orthodontic Department of the University of Damascus Dental School will be examined and subjects who meet the inclusion criteria will be included. Then, initial diagnostic records (diagnostic gypsum models, internal and external oral photographs, and radiographic images) will be studied to ensure that the selection criteria are accurately matched.\n\nThis study aims to compare two groups of patients with moderate crowding of the lower anterior teeth. Experimental group: the patients in this group will be treated with periodontally accelerated osteogenic orthodontics Control group: the patients in this group will be treated using fixed appliances without any acceleration method.', 'detailedDescription': 'Correction of irregular teeth can take a long time, and this depends on various factors such as the good compliance of the patient, the amount of dental crowding, and the need for extraction in the course of orthodontic treatment.\n\nMany methods have been used to accelerate tooth movement, and recently the PAOO technique has emerged as an effective therapeutic intervention.\n\nPAOO is a promising procedure but only a few cases were reported in the literature. Controlled clinical and histological studies are needed to understand the biology of tooth movement with this procedure, the effect on teeth and bone, post-retention stability, measuring the volume of mature bone formation, and determining the status of the periodontium and roots after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '28 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* skeletal class I malocclusion (ANB=2-4)\n* normal vertical growth pattern.\n* moderate crowding of lower anterior teeth (i.e., 4-6 millimeters of a tooth size-arch length discrepancy)\n* 1 to 3 mm of overjet and 1 to 4 mm of the overbite\n* good oral health\n\nExclusion Criteria:\n\n* medical, social, and psycho contraindications to oral surgery\n* presence of periodontal diseases\n* poor oral hygiene\n* previous orthodontic treatment'}, 'identificationModule': {'nctId': 'NCT05390320', 'briefTitle': 'Dental and Periodontal Changes Following the Acceleration of Alignment of Crowded Lower Anterior Teeth Using a Surgical Technique', 'organization': {'class': 'OTHER', 'fullName': 'Damascus University'}, 'officialTitle': 'Dental and Periodontal Changes Following the Acceleration of Decrowding of Lower Anterior Teeth Using a PAOO Procedure: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'UDDS-Ortho-10-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Periodontally accelerated osteogenic orthodontics', 'description': 'The patients in this group will be treated by periodontally accelerated osteogenic orthodontics using fixed appliances.', 'interventionNames': ['Procedure: PAOO']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional treatment', 'description': 'The patients in this group will be treated using fixed appliances and conventional treatment without any surgical intervention to accelerate tooth movement.', 'interventionNames': ['Other: Fixed appliance']}], 'interventions': [{'name': 'PAOO', 'type': 'PROCEDURE', 'description': 'Periodontally accelerated osteogenic orthodontics will be applied to treat patients with moderate crowding.', 'armGroupLabels': ['Periodontally accelerated osteogenic orthodontics']}, {'name': 'Fixed appliance', 'type': 'OTHER', 'description': 'Fixed appliances will be applied to treat patients with moderate crowding without any acceleration methods.', 'armGroupLabels': ['Conventional treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Damascus', 'country': 'Syria', 'facility': 'University of Damascus', 'geoPoint': {'lat': 33.5102, 'lon': 36.29128}}], 'overallOfficials': [{'name': 'Hallaj I Alsino, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of orthodontics, Damascus University, Syria'}, {'name': 'Mohammad Y Hajeer, DDS,MSc,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of orthodontics, Damascus University, Syria'}, {'name': 'Issam Khoury, DDS,MSc,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Oral and Maxillofacial Surgery, Damascus University, Syria'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Damascus University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}