Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 9:44 PM
Study NCT ID:
NCT07408895
Status:
COMPLETED
Last Update Posted:
2026-02-13
First Post:
2026-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Injectable Platelet Rich Derivatives on Orthodontic Canine Retraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Split-mouth randomized controlled design in which different interventions were applied to opposite sides within the same participant.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2026-01-26', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Orthodontic Canine Retraction', 'timeFrame': 'From baseline (initiation of orthodontic canine retraction) until completion of canine retraction, assessed monthly for up to 4 months.', 'description': 'The amount of orthodontic canine movement measured in millimeters.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Accelerate Tooth Movement']}, 'descriptionModule': {'briefSummary': 'This study evaluated the effect of injectable platelet-rich derivatives on the rate of orthodontic canine retraction. Patients requiring orthodontic canine retraction following premolar extraction were enrolled and divided into three groups using a split-mouth design. Injectable platelet-rich plasma (PRP) and platelet-rich fibrin (PRF) were applied to compare their effects on the rate of tooth movement. The outcomes were assessed by measuring the amount of canine retraction over time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '29 Years', 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy individuals aged 17-29 years (mean age 24 ± 6 years)\n* Diagnosis of Class I bimaxillary protrusion or Class II division 1 requiring first premolar extractions\n* Full permanent dentition\n* Good oral hygiene\n* Non-smokers\n* Not taking medications affecting bone metabolism (e.g., bisphosphonates)\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Contraindications to platelet therapies (e.g., platelet dysfunction)\n* Severe malocclusion unsuitable for fixed appliances\n* Dental anomalies (size/shape)\n* Systemic syndromes'}, 'identificationModule': {'nctId': 'NCT07408895', 'briefTitle': 'Effect of Injectable Platelet Rich Derivatives on Orthodontic Canine Retraction', 'organization': {'class': 'OTHER', 'fullName': "Sana'a University"}, 'officialTitle': 'The Effect of Injectable Platelet Rich Derivatives on the Rate of Orthodontic Canine Retraction: A Split-Mouth Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SU-DENT-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRP vs Control (Split-Mouth)', 'description': 'Split-mouth group in which one side received platelet-rich plasma (PRP) injection and the contralateral side served as a control without injection during orthodontic canine retraction.', 'interventionNames': ['Biological: Platelet-Rich Plasma (PRP)']}, {'type': 'EXPERIMENTAL', 'label': 'PRF vs Control (Split-Mouth)', 'description': 'Split-mouth group in which one side received platelet-rich fibrin (PRF) injection and the contralateral side served as a control without injection during orthodontic canine retraction.', 'interventionNames': ['Biological: Platelet-Rich Fibrin (PRF)']}], 'interventions': [{'name': 'Platelet-Rich Plasma (PRP)', 'type': 'BIOLOGICAL', 'description': "Autologous platelet-rich plasma prepared from the patient's own blood and injected locally at the experimental side to accelerate orthodontic canine retraction.", 'armGroupLabels': ['PRP vs Control (Split-Mouth)']}, {'name': 'Platelet-Rich Fibrin (PRF)', 'type': 'BIOLOGICAL', 'description': "Autologous platelet-rich fibrin prepared from the patient's own blood and injected locally to accelerate orthodontic canine retraction.", 'armGroupLabels': ['PRF vs Control (Split-Mouth)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sanaa', 'country': 'Yemen', 'facility': "Faculty of Dentistry, Sana'a University", 'geoPoint': {'lat': 15.35452, 'lon': 44.20646}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Individual participant data will not be shared because this study was conducted as part of a master's degree thesis and the data are subject to institutional and ethical restrictions."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Sana'a University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yusra Ali Al Shawri', 'investigatorAffiliation': "Sana'a University"}}}}