Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-25 @ 9:42 PM
Study NCT ID:
NCT05183451
Status:
COMPLETED
Last Update Posted:
2022-01-10
First Post:
2021-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect Of Low Level Laser Therapy on the Rate of En- Masse Retraction: RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'], 'maskingDescription': 'Due to the nature of the intervention neither the operator nor the patients could be blinded. The assessors will be blinded from the data to be investigated he will just measure the data needed without knowing the purpose of the study, and without knowing which records belong to which group. Two assessors will carry out the the analysis of the study, blindly and independently.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-21', 'studyFirstSubmitDate': '2021-12-05', 'studyFirstSubmitQcDate': '2021-12-21', 'lastUpdatePostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of en-masse retraction', 'timeFrame': "From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year", 'description': 'The antero-posterior movement of anterior teeth will be assessed by measuring the digitilized study models taken of the patients monthly (measured in mm)'}], 'secondaryOutcomes': [{'measure': "Anterior teeth's root resorption", 'timeFrame': "From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year", 'description': 'Assessed via comparing the pre \\& post- retraction CBCTs using Lavender \\& Malmgren Grading system'}, {'measure': 'Anterior teeth Tip and Torque', 'timeFrame': "From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year", 'description': "By comparing angular changes in the teeth's tip and torque in relation to reference planes"}, {'measure': 'Anchorage (Loss/ Gain)', 'timeFrame': "From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year", 'description': 'By comparing linear and angular changes in the first molars in relation to reference planes'}, {'measure': "First molars' rotation", 'timeFrame': "From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year", 'description': 'Study models that are taken pre and post retraction (then digitilized) will be used to assess the rotation of the maxillary first molars in relation to a reference line'}, {'measure': 'Pain Associated', 'timeFrame': "From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year", 'description': 'Each patient will fill a questionnaire regarding his treatment experience in a VAS scoring from 0-10'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['En-masse retraction', 'Rate of tooth movement', 'Low Level Laser Therapy (LLLT)', '3D'], 'conditions': ['Bimaxillary Protrusion']}, 'referencesModule': {'references': [{'pmid': '38842738', 'type': 'DERIVED', 'citation': 'Dehis HM, El Sharaby FA, Eid FH, Mostafa YA. Effect of low-level laser therapy on en masse retraction in females with bimaxillary dentoalveolar protrusion : A single-center randomized clinical trial. J Orofac Orthop. 2025 Sep;86(5):284-297. doi: 10.1007/s00056-024-00525-2. Epub 2024 Jun 6.'}]}, 'descriptionModule': {'briefSummary': 'There is scarcity in the literature regrading the effect of Low Level Laser Therapy (LLLT) on the rate of en-masse retraction. This study aims to investigate whether LLLT would affect the rate of en-masse retraction in females having bimaxillary dento-alveolar protrusion.', 'detailedDescription': 'Individuals having bimaxillary dentoalveolar protrusion are characterized by proclined upper and lower incisors and increased procumbency of the lips thus suffering from poor facial esthetics. The conventional management of these patients is the extraction of the first premolars and retraction of the anterior teeth.\n\nOne of the treatment techniques is in the form of canine retraction followed by four incisors retraction. This conventional method takes tedious work and tremendous time, thus affecting the patients\' satisfaction adversely. The other technique is retraction of the whole set of anterior teeth as one unit (Canine and incisors), which is referred to as "En-Masse retraction".\n\nEnhancing the rate of orthodontic tooth movement has always been a supreme goal of orthodontic research hoping to raise the level of care delivered to patients, hence, increase patients\' satisfaction.\n\nOne of the proposed modalities of increasing the rate of tooth movement is Low Level Laser Therapy (LLLT). Thus, the aim of the current consideration was to evaluate the impact of LLLT on the rate of en-masse retraction in adult females having bimaxillary dentoalveolar protrusion.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult females\n* Patients having bimaxillary dento- alveolar protrusion and Class I Molar relation\n* Cases requiring maximum anchorage during retraction.\n* Good general and oral health\n\nExclusion Criteria:\n\n* Patients suffering from any systemic diseases interfering with tooth movement.\n* Patients with extracted or missing permanent teeth. (except for third molars).\n* Patients with badly decayed teeth (Other than 1st premolars).\n* Patients with any parafunctional habits (i.e. Bruxism, tongue thrusting, mouth breathing, etc…).\n* Patients with previous orthodontic treatment\n* Pregnant females'}, 'identificationModule': {'nctId': 'NCT05183451', 'briefTitle': 'Effect Of Low Level Laser Therapy on the Rate of En- Masse Retraction: RCT', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Low-level Laser Therapy on the Rate of En-masse Retraction in Adult Females With Bimaxillary Dentoalveolar Protrusion: a Single-center Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'FDCU-REC (2)/12-2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LG (Group A)', 'description': 'En- masse retraction using NiTi closed coil springs rendering 200 g/side were employed following first premolars extraction and insertion of buccal TADs to provide maximum anchorage. Retraction was done along with the application of LLLT till the end of retraction.', 'interventionNames': ['Procedure: En- masse retraction and LLLT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NLG (Group B)', 'description': 'En- masse retraction using NiTi closed coil springs rendering 200 g/side were employed following first premolars extraction and insertion of buccal TADs to provide maximum anchorage. No LLLT was applied to this group', 'interventionNames': ['Procedure: En- masse retraction without LLLT']}], 'interventions': [{'name': 'En- masse retraction and LLLT', 'type': 'PROCEDURE', 'otherNames': ['Laser group', 'Group A'], 'description': 'Retraction will start on a 0.019"x0.025" Stainless steel wire using NiTi closed coils (force applied will be 200 g per side) extending between the crimpable hooks and the TADs. LLLT will be applied on days 0,3,7,14 from extraction then repeated biweekly till the end of retraction.', 'armGroupLabels': ['LG (Group A)']}, {'name': 'En- masse retraction without LLLT', 'type': 'PROCEDURE', 'otherNames': ['No laser group', 'Group B'], 'description': 'Retraction will start on a 0.019"x0.025" Stainless steel wire using NiTi closed coils (force applied will be 200 g per side) extending between the crimpable hooks and the TADs.', 'armGroupLabels': ['NLG (Group B)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Heba Mohamed E Dehis, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}, {'name': 'Foad A El-Sharaby, A. Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Faten H Eid, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Mushira Dahaba, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Yehya A Mostafa, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Future University in Egypt (FUE)'}]}, 'ipdSharingStatementModule': {'url': 'https://fsharaby@hotmail.com', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be available immediately following publication and ending 6 months following article publication', 'ipdSharing': 'YES', 'description': 'Research data will be available for researchers who provide a methodologically sound proposal.\n\nProposals should be directed to the corresponding author. To gain access, data requestors will need to sign a data access agreement.', 'accessCriteria': 'Data will be available after contact with the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Orthodontics', 'investigatorFullName': 'Heba Mohamed El- Sayed Dehis', 'investigatorAffiliation': 'Cairo University'}}}}