Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-28 @ 5:49 PM
Study NCT ID:
NCT04316403
Status:
COMPLETED
Last Update Posted:
2020-03-24
First Post:
2020-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laser-assisted Flapless Corticotomy in Accelerating Canine Retraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008312', 'term': 'Malocclusion, Angle Class II'}, {'id': 'D057887', 'term': 'Overbite'}], 'ancestors': [{'id': 'D008310', 'term': 'Malocclusion'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053844', 'term': 'Lasers, Solid-State'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-21', 'studyFirstSubmitDate': '2020-03-18', 'studyFirstSubmitQcDate': '2020-03-18', 'lastUpdatePostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the canine retraction rate', 'timeFrame': '10 minutes after laser application, one, two, four, 8 and 12 weeks after laser application', 'description': 'The distance between the first molar labial hook and the canine bracket hook was recorded using Digital Boely gauge and then this distance was divided by the time that passed between two assessment points.'}], 'secondaryOutcomes': [{'measure': 'Change in the levels of pain and discomfort', 'timeFrame': 'at the 1st day following laser application (10 minutes) and at the 3rd, 5th and 7th days following laser application', 'description': "A questionnaire was administered at the 1st, 3rd, 5th and 7th day after laser application. The questionnaire contained 5 questions (using 4-point Likert ordinal scales) to collect patients' responses on the following questions:\n\nQuestion 1: Do you feel pain during eating? Question 2: Do you feel pain during the day? Question 3: Do you feel pain that can awaken you during the night? Question 4: Do you feel swollen on the surgical side?\n\nThe possible answers were:\n\n1\\. No 2.Mild 3.Moderate 4. Severe For the first four questions, the higher the score, the worse the feeling was.\n\nQuestion 5: Which one of the following has caused more discomfort to you?\n\n1\\. Extraction of premolars 2. Laser application 3.Both"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tooth movement', 'Acceleration of tooth movement', 'Er:YAG laser-assisted corticotomy'], 'conditions': ['Class II Division 1 Malocclusion', 'Maxillary Prognathism', 'Protrusion, Incisor']}, 'referencesModule': {'references': [{'pmid': '20152672', 'type': 'BACKGROUND', 'citation': 'Fisher MA, Wenger RM, Hans MG. Pretreatment characteristics associated with orthodontic treatment duration. Am J Orthod Dentofacial Orthop. 2010 Feb;137(2):178-86. doi: 10.1016/j.ajodo.2008.09.028.'}, {'pmid': '15180086', 'type': 'BACKGROUND', 'citation': 'Segal GR, Schiffman PH, Tuncay OC. Meta analysis of the treatment-related factors of external apical root resorption. Orthod Craniofac Res. 2004 May;7(2):71-8. doi: 10.1111/j.1601-6343.2004.00286.x.'}, {'pmid': '24680026', 'type': 'BACKGROUND', 'citation': "Uribe F, Padala S, Allareddy V, Nanda R. Patients', parents', and orthodontists' perceptions of the need for and costs of additional procedures to reduce treatment time. Am J Orthod Dentofacial Orthop. 2014 Apr;145(4 Suppl):S65-73. doi: 10.1016/j.ajodo.2013.12.015."}, {'pmid': '27484605', 'type': 'BACKGROUND', 'citation': 'Hassan SE, Hajeer MY, Alali OH, Kaddah AS. The Effect of Using Self-ligating Brackets on Maxillary Canine Retraction: A Split-mouth Design Randomized Controlled Trial. J Contemp Dent Pract. 2016 Jun 1;17(6):496-503. doi: 10.5005/jp-journals-10024-1879.'}, {'pmid': '27869476', 'type': 'BACKGROUND', 'citation': 'AlSayed Hasan MMA, Sultan K, Hamadah O. Low-level laser therapy effectiveness in accelerating orthodontic tooth movement: A randomized controlled clinical trial. Angle Orthod. 2017 Jul;87(4):499-504. doi: 10.2319/062716-503.1. Epub 2016 Nov 21.'}, {'pmid': '2133892', 'type': 'BACKGROUND', 'citation': 'Hashimoto H. Effect of micro-pulsed electricity on experimental tooth movement. Nihon Kyosei Shika Gakkai Zasshi. 1990 Aug;49(4):352-61.'}, {'pmid': '33876339', 'type': 'DERIVED', 'citation': 'Jaber ST, Al-Sabbagh R, Hajeer MY. Evaluation of the efficacy of laser-assisted flapless corticotomy in accelerating canine retraction: a split-mouth randomized controlled clinical trial. Oral Maxillofac Surg. 2022 Mar;26(1):81-89. doi: 10.1007/s10006-021-00963-x. Epub 2021 Apr 20.'}]}, 'descriptionModule': {'briefSummary': "Erbium lasers have been suggested to accomplish corticotomy without flap reflection due to their attractive advantages. The current trial aimed to evaluate the efficacy of laser-assisted flapless corticotomy in accelerating orthodontic tooth movement. The secondary aim was to evaluate the patients' responses to laser application. It was postulated that canine retraction after laser-assisted flapless corticotomy would be accomplished within a shorter period compared with the conventional canine retraction method, with no significant degree of pain and discomfort.", 'detailedDescription': 'Comprehensive orthodontic treatment with fixed appliances usually takes more than 18 months in mild and severe cases. Prolonged treatment time can cause many adverse effects such as pain, discomfort, external root resorption, white spots and dental caries. Decreasing the treatment time for tooth movement has been the focus of both the clinicians and the patients. For the last few decades, investigators have recommended many treatment approaches intending to reduce overall treatment time such as low friction and self-ligating bracket systems, low-level laser irradiation, electrical currents, pharmacological approaches, local platelet-rich plasma (PRP) injection and surgical approaches like dentoalveolar distraction and selective alveolar decortication or corticotomy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '26 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Class II division 1 patients requiring orthodontic treatment with fixed appliances and a need for upper first-premolar extraction using a two-step retraction technique.\n* Permanent dentition with an age range from 16 to 24 years.\n* Healthy with no systemic conditions.\n* Adequate oral hygiene and healthy periodontal tissues\n* no previous orthodontic treatment\n* Absence of canine endodontic treatment.\n\nExclusion Criteria:\n\n* Bimaxillary dentoalveolar severe protrusion.\n* Previous orthodontic treatment.\n* Subject with psychological abnormalities.\n* Subject with systemic diseases.'}, 'identificationModule': {'nctId': 'NCT04316403', 'briefTitle': 'Laser-assisted Flapless Corticotomy in Accelerating Canine Retraction', 'organization': {'class': 'OTHER', 'fullName': 'Damascus University'}, 'officialTitle': 'Evaluation of the Efficacy of Laser-assisted Flapless Corticotomy in Accelerating Canine Retraction: A Split-mouth Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'UDDS-Ortho-01-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laser-assisted corticotomy', 'description': 'Er:YAG laser beam was used to perform several perforations to the alveolar bone around the canine in one side of the mouth hoping that would accelerate canine retraction', 'interventionNames': ['Procedure: Er:YAG laser']}, {'type': 'NO_INTERVENTION', 'label': 'Traditional treatment', 'description': 'Canines in this group were retracted by the conventional manner.'}], 'interventions': [{'name': 'Er:YAG laser', 'type': 'PROCEDURE', 'description': 'This application was made before the onset of canine retraction in one side of the mouth', 'armGroupLabels': ['Laser-assisted corticotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12JO76WH', 'city': 'Hama', 'country': 'Syria', 'facility': 'Orthodontic Department, University of Hama Dental School', 'geoPoint': {'lat': 35.13179, 'lon': 36.75783}}], 'overallOfficials': [{'name': 'Samer T Jaber, DDS MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PhD student, Orthodontics Department, University of Damascus Dental School'}, {'name': 'Rabab Al-sabbagh, DDS MSc PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor of Orthodontics, University of Hama, Hama, Syria'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Damascus University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}