Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-03-12 @ 12:31 AM
Study NCT ID:
NCT05227859
Status:
COMPLETED
Last Update Posted:
2022-02-07
First Post:
2022-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Which is Better Piezosurgery or LLLT in Accelerating Orthodontic Tooth Movement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057887', 'term': 'Overbite'}], 'ancestors': [{'id': 'D008312', 'term': 'Malocclusion, Angle Class II'}, {'id': 'D008310', 'term': 'Malocclusion'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-03', 'studyFirstSubmitDate': '2022-01-25', 'studyFirstSubmitQcDate': '2022-02-03', 'lastUpdatePostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of upper canine retraction', 'timeFrame': 'The months required to complete the retraction procedure will be recorded. Completion of this procedure is expected to occur within four months in the experimental groups and seven months in the control group', 'description': 'Assessment will be performed by calculating the months required to achieve complete retraction of the upper canine retraction through clinical examination.'}, {'measure': 'Rate of retraction', 'timeFrame': 'Time Frame: The calculation of the rate of retraction will be done once the retraction procedures have finished. Completion of this procedure is expected to occur within 4 months in the experimental groups and 7 months in the control group.', 'description': 'Assessment will be performed on study models. The amount of distance being retracted in millimeters will be divided by the duration of retraction in weeks to give an estimation of the retraction rate.'}], 'secondaryOutcomes': [{'measure': "Change in Molars' positions", 'timeFrame': 'T0: 1 day before the beginning of canine retraction; T1: after 1 month of retraction; T2: after 2 months of retraction; T3: after 3 months; and T4: at the end of retraction (expected to be within 4 months to 7 months))', 'description': 'The amount of distance being traveled by the first molars is going to be measured on study models taken at monthly intervals until the end of the retraction phase.'}, {'measure': "Change in canine' rotation", 'timeFrame': 'T0: 1 day before the beginning of canine retraction; T1: after 1 month of retraction; T2: after 2 months of retraction; T3: after 3 months of retraction; and T4: at the end of retraction (expected to be within 4 months to 7 months)', 'description': 'The amount of the rotation of canine is going to be measured on study models taken at monthly intervals until the end of the retraction phase.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LLLT', 'Piezocision', 'Canine retraction', 'Acceleration'], 'conditions': ['Class II Malocclusion']}, 'referencesModule': {'references': [{'pmid': '30559886', 'type': 'BACKGROUND', 'citation': 'Abdelhameed AN, Refai WMM. Evaluation of the Effect of Combined Low Energy Laser Application and Micro-Osteoperforations versus the Effect of Application of Each Technique Separately On the Rate of Orthodontic Tooth Movement. Open Access Maced J Med Sci. 2018 Nov 15;6(11):2180-2185. doi: 10.3889/oamjms.2018.386. eCollection 2018 Nov 25.'}, {'pmid': '25728102', 'type': 'BACKGROUND', 'citation': 'Rajasekaran UB, Krishna Nayak US. Effect of prostaglandin E1 versus corticotomy on orthodontic tooth movement: an in vivo study. Indian J Dent Res. 2014 Nov-Dec;25(6):717-21. doi: 10.4103/0970-9290.152170.'}, {'pmid': '32990775', 'type': 'BACKGROUND', 'citation': 'Turker G, Yavuz I, Gonen ZB. Which method is more effective for accelerating canine distalization short term, low-level laser therapy or piezocision? A split-mouth study. J Orofac Orthop. 2021 Jul;82(4):236-245. doi: 10.1007/s00056-020-00250-6. Epub 2020 Sep 29.'}, {'pmid': '33962809', 'type': 'BACKGROUND', 'citation': 'Cagli Karci I, Baka ZM. Assessment of the effects of local platelet-rich fibrin injection and piezocision on orthodontic tooth movement during canine distalization. Am J Orthod Dentofacial Orthop. 2021 Jul;160(1):29-40. doi: 10.1016/j.ajodo.2020.03.029. Epub 2021 May 4.'}, {'pmid': '27021451', 'type': 'BACKGROUND', 'citation': 'Abbas NH, Sabet NE, Hassan IT. Evaluation of corticotomy-facilitated orthodontics and piezocision in rapid canine retraction. Am J Orthod Dentofacial Orthop. 2016 Apr;149(4):473-80. doi: 10.1016/j.ajodo.2015.09.029.'}]}, 'descriptionModule': {'briefSummary': 'Sixty patients need extraction-based treatment of the maxillary first premolars with subsequent retraction of the maxillary canines will be divided randomly into three groups: piezocision group, low-level laser therapy group, and control group. In each group, the canine retraction will be started after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side. For anchorage, a soldered trans-palatal arch will be used.\n\nPre- and post distalization dental casts will be assessed to study the rate of canine retraction, as well as, canine rotation and anchorage loss over a follow-up period until a class I canine relationship is achieved.', 'detailedDescription': 'Before enrollment of each subject into the study, they will be examined completely to ensure their eligibility for this study. The operator will inform them about the aim of the study and ask them to provide written informed consent.\n\nAt the end of leveling and alignment stage, the upper first premolars will be extracted. The rectangular stainless steel archwires (0.019" × 0.025") will be inserted, then after one month, the canine retraction will be started.\n\nRegarding the Piezocision, after anesthesia, three vertical incisions will be made (3-mm depth and 8-10 mm length) mesial and distal the upper canine as well as at an equal distance from the upper canine and 2nd premolar. The surgical procedures will be repeated after six weeks (only the mesial and distal canine incisions will be done) Regarding the low-level laser therapy (LLLT): GaALAs diode laser (wavelength: 810 nm and exposure time of 10 seconds\\\\point) will be applied around the upper canine in 10 sites from buccal and palatal. The middle of the extraction site will be also irradiated in 4 sites (2 buccally and 2 palatally). The LLLT will be applied 5 times in the first month of canine retraction, then every two weeks until class I canine relationship will be achieved.\n\nThe upper canine destalization will be done using NiTi springs. The force level will be controlled every 2 weeks. Retraction will be stopped when a class I canine relationship in both sides.\n\nDental casts will be used for the quantification of the anteroposterior movement of the upper canine and the first molars every 30 days until the class I canine relationship will be achieved.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '28 Years', 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult healthy patients, Male and female, Age range: 17-28 years.\n2. Class II Division 1 malocclusion :\n\n * Mild/moderate skeletal Class II (sagittal discrepancy angle ≤7)\n * Overjet ≤10\n * Normal or excessive facial height (Clinically and then cephalometrically assessed using these three angles: mandibular/cranial base angle, maxillary/mandibular plane angle, and facial axis angle)\n * Mild to moderate crowding ≤ 4\n3. Permanent occlusion.\n4. Existence of all the upper teeth (except third molars).\n5. Good oral and periodontal health:\n\n * Probing depth \\< 4 mm\n * No radiographic evidence of bone loss.\n * Gingival index ≤ 1\n * Plaque index ≤ 1\n\nExclusion Criteria:\n\n1. Medical problems that affect tooth movement (corticosteroid, nonsteroidal anti-inflammatory drugs (NSAIDs), …)\n2. Presence of primary teeth in the maxillary arch\n3. Missing permanent maxillary teeth (except third molars).\n4. Poor oral hygiene or Current periodontal disease:\n\n * Probing depth ≥ 4 mm\n * radiographic evidence of bone loss\n * Gingival index \\> 1\n * Plaque index \\> 1\n5. Patient had previous orthodontic treatment'}, 'identificationModule': {'nctId': 'NCT05227859', 'briefTitle': 'Which is Better Piezosurgery or LLLT in Accelerating Orthodontic Tooth Movement', 'organization': {'class': 'OTHER', 'fullName': 'Damascus University'}, 'officialTitle': 'Assessment of the Effects of Piezocision and Low-level Laser Therapy on Orthodontic Tooth Movement During Canine Retraction and the Associated Dentoalveolar Changes: A Three-arm Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'UDDS-Ortho-01-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Piezocision therapy', 'description': 'In this group of patients, the canine will be retracted in association with piezocision.', 'interventionNames': ['Procedure: Piezocision']}, {'type': 'EXPERIMENTAL', 'label': 'Low-level laser therapy', 'description': 'In this group of patients, the canine will be retracted in association with LLLT.', 'interventionNames': ['Device: Low-level laser']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional treatment', 'description': 'In this group of patients, the canine will be retracted conventionally without any acceleration intervention.', 'interventionNames': ['Device: Conventional treatment']}], 'interventions': [{'name': 'Piezocision', 'type': 'PROCEDURE', 'description': 'After anesthesia, three vertical incisions will be made (3-mm depth and 8-10 mm length) mesial and distal the upper canine as well as at an equal distance from the upper canine and 2nd premolar. The surgical procedures will be repeated after six weeks (only the mesial and distal canine incisions will be done)', 'armGroupLabels': ['Piezocision therapy']}, {'name': 'Low-level laser', 'type': 'DEVICE', 'description': 'GaALAs diode laser (wavelength: 810 nm and exposure time of 10 seconds\\\\point) will be applied around the upper canine in 10 sites from buccal and palatal. The middle of the extraction site will be also irradiated in 4 sites (2 buccally and 2 palatally). The LLLT will be applied 5 times in the first month of canine retraction, then every two weeks until class I canine relationship will be achieved.', 'armGroupLabels': ['Low-level laser therapy']}, {'name': 'Conventional treatment', 'type': 'DEVICE', 'description': 'The upper canine destalization will be done using NiTi springs. The force level will be controlled every 2 weeks. Retraction will be stopped when a class I canine relationship in both sides.', 'armGroupLabels': ['Conventional treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Damascus', 'country': 'Syria', 'facility': 'Department of Orthodontics, University of Damascus Dental School', 'geoPoint': {'lat': 33.5102, 'lon': 36.29128}}], 'overallOfficials': [{'name': "Doa'a Tahseen Alfailany, DDS", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Orthodontics, University of Damascus Dental School, Syria'}, {'name': 'Mohammad Y Hajeer, DDS MSc PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor of Orthodontics, University of Damascus Dental School, Syria'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Damascus University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}