Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2026-01-10 @ 2:47 PM
Study NCT ID:
NCT06520761
Status:
UNKNOWN
Last Update Posted:
2024-07-25
First Post:
2024-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Injectable PRF Vs LLL on Orthodontic Tooth Movement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012391', 'term': 'Root Resorption'}], 'ancestors': [{'id': 'D014091', 'term': 'Tooth Resorption'}, {'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': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-20', 'studyFirstSubmitDate': '2024-07-20', 'studyFirstSubmitQcDate': '2024-07-20', 'lastUpdatePostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of canine retraction', 'timeFrame': '4 month', 'description': 'measure the rate of distal movement of the upper canine'}], 'secondaryOutcomes': [{'measure': 'Root resorption of upper canine', 'timeFrame': '4 month', 'description': 'measure root resorption of upper canine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rate of Canine Retraction', 'Root Resorption']}, 'referencesModule': {'references': [{'pmid': '33481053', 'type': 'BACKGROUND', 'citation': 'Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Effect of injectable platelet-rich fibrin (i-PRF) in accelerating orthodontic tooth movement : A randomized split-mouth-controlled trial. J Orofac Orthop. 2021 Jul;82(4):268-277. doi: 10.1007/s00056-020-00275-x. Epub 2021 Jan 22.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/33481053/', 'label': 'The role of platelet-rich fibrin (PRF) in accelerating orthodontic tooth movement has been controversially discussed in available clinical studies. Objective: To investigate the effectiveness of i-PRF in accelerating maxillary canine retraction.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the present study is to compare the effect of injectable platelet fibrin and Low Level LASER therapy on the rate of upper canine retraction, and on root resorption of the canine', 'detailedDescription': 'the study involves two groups the first group received low level laser at the upper right canine, while the upper left canine act as a control. The second group received injectable platelet rich fibrin at the upper right canine, while the upper left canine act as a control. in each group we will compare rate of canine retraction between both sides, and amount of root resorption also we will compare both groups regarding rate of canine retraction and amount of root resorption'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with age 18 years or older.\n2. Presence of all permanent teeth except for the third molar.\n3. Presence of malocclusion requiring maxillary first premolar extraction such as (class II division 1 or bimaxillary dentoalveolar protrusion).\n\nExclusion Criteria:\n\n1. Patient with a history of previous orthodontic treatment.\n2. Medical problems may interfere with orthodontic treatment.\n3. Bad oral hygiene.'}, 'identificationModule': {'nctId': 'NCT06520761', 'briefTitle': 'The Effect of Injectable PRF Vs LLL on Orthodontic Tooth Movement', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Faculty of Dental Medicine for Girls'}, 'officialTitle': 'The Effect of Injectable Platelet Rich Fibrin Versus Low-Level LASER Therapy on The Rate of Orthodontic Tooth Movement', 'orgStudyIdInfo': {'id': 'ORTHO-108-5-b'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'injectable platelet rich fibrin', 'description': 'blood sample is collected from the patient, centrifuged at 700rpm for 3 minutes then the resulted injectable platelet rich fibrin is injected around the upper right canine while the upper left canine act as a control', 'interventionNames': ['Procedure: Injectable platelet rich fibrin']}, {'type': 'EXPERIMENTAL', 'label': 'Low Level LASER', 'description': 'low level laser from diode laser machine is applied around the upper right canine and the upper left canine acts as a control', 'interventionNames': ['Device: Low Level LASER']}], 'interventions': [{'name': 'Injectable platelet rich fibrin', 'type': 'PROCEDURE', 'description': 'blood sample obtained from the participant, centrifuged at 700 rpm to produce injectable platelet rich fibrin, this will be injected around the upper canine', 'armGroupLabels': ['injectable platelet rich fibrin']}, {'name': 'Low Level LASER', 'type': 'DEVICE', 'description': 'Diode LASER device is used to apply Low Level LASER around the upper canine', 'armGroupLabels': ['Low Level LASER']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02', 'city': 'Cairo', 'state': 'Naser City', 'country': 'Egypt', 'facility': 'Faculty of Dental Medicine for Girls Al Azhar university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Samir A Ebrahim, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of orthodontic department at faculty of Dental Medicine for Girls Al-Azhar university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculty of Dental Medicine for Girls', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}