Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-01 @ 2:09 PM
Study NCT ID:
NCT07103551
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-07
First Post:
2025-07-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy of Injectable Platelet-rich Plasma in Tooth Movement Acceleration With Clear Aligner
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008310', 'term': 'Malocclusion'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2025-07-29', 'studyFirstSubmitQcDate': '2025-07-29', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Measuring the amount of tooth movement in group of clear aligner therapy and group of clear aligners with injectable platelet-rich plasma by little's irregularity index", 'timeFrame': 'Baseline, 3 weeks, and 6 weeks', 'description': "Little's irregularity index is used to measure the amount of tooth movement by measuring the distance between each contact points in anterior teeth before injection and after injection"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Malocclusion', 'Clear aligner', 'Platelet-rich plasma'], 'conditions': ['Clear Aligner Appliance']}, 'descriptionModule': {'briefSummary': 'Aim of the study is evaluation of the efficacy of injectable platelet-rich plasma in orthodontic tooth movement acceleration with clear aligner', 'detailedDescription': "Malocclusion is frequently viewed as detrimental to one' self-worth and overall physical, social, and mental health. On the past few years, more and more grown-up patients have persued orthodontic care and they want attractive and pleasant options instead of traditional braces. CLEAR aligners that meet this need are also subject to technological advancements in the materials used and the methods of production. Consequently, CAT has merged as the leading trend in orthodontic innovation. The primary advateges of clear aligner therapy include the option to remove while eating, enhanced oral hygiene practices, less discomfort for patients,and the capability to visualize the treatment outcome through computer applications.\n\nClear aligners need to be removed during eating, when drinking hot beverages that may lead to warping, while having sugary beverages, and also when cleaning teeth.\n\nToday, numerous methods have emerged to accelerate orthodontic tooth movement, encompassing invasive,minimally invasive,and non-invasive strategies.\n\nIN addition, the use of medications and autologous biological solutions, like platelet-rich plasma, has been suggested.\n\nOne of the recently utilized local agents to accelerate the process of orthodontic tooth movement is platelet-rich plasma.\n\nPlatelet-rich plasma is characterized as an autologous concentration of platelets within a small quantity of plasma Prepared from blood centrifuging double spin.\n\nThe application of PRP has been used in regenerative dentistry and healing acceleration in oral surgery.\n\nPRP serves as an abundant reservoir of cytokines and contains seven essential growth factors:\n\n* Platelet-derived growth factors .\n* Transforming growth factors.\n* Epidermal growth factors.\n* Vascular endothelial growth factor. The diverse range of growth factors present in PRP might facilitate the simultaneous activation of both osteoblasts and osteoclasts, reinforcing the notion that PRP can influence the movement of teeth during orthodontic treatment.\n\nAlso elevated levels of cytokine production during the process of bone remodelling could accelerate tooth movement."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-extraction cases\n* Complete permanent dentition\n* Good oral hygiene\n* Healthy periodontal condition\n* Single or double arch treatment\n* No therapeutic intervention planned intermaxillary or other intraoral or extraoral appliances including lip bumper, elastics and maxillary expansion appliances\n* mild to moderate crowding\n\nExclusion Criteria:\n\n* Systemic medical conditions\n* Dental anomalies in tooth size or shape\n* Current use of anti-inflammatory medications'}, 'identificationModule': {'nctId': 'NCT07103551', 'briefTitle': 'Evaluation of the Efficacy of Injectable Platelet-rich Plasma in Tooth Movement Acceleration With Clear Aligner', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Evaluation of the Efficacy of Injectable Platelet-rich Plasma in Orthodontic Tooth Movement Acceleration With Clear Aligner Therapy', 'orgStudyIdInfo': {'id': 'Clear Aligner and prp'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Clear aligner therapy only without injection of platelet-rich plasma', 'description': 'Clear aligner only without acceleration'}, {'type': 'EXPERIMENTAL', 'label': 'Clear aligner Therapy with injection of platelet-rich plasma', 'description': 'Clear aligner therapy with injection of platelet-rich plasma', 'interventionNames': ['Biological: Platelet-rich plasma']}], 'interventions': [{'name': 'Platelet-rich plasma', 'type': 'BIOLOGICAL', 'description': 'Platelet-rich plasma used during clear aligner therapy for acceleration of Orthodontic Tooth Movement', 'armGroupLabels': ['Clear aligner Therapy with injection of platelet-rich plasma']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ali Mahmoud Elhewaity', 'role': 'CONTACT', 'email': 'alimahmoud9779@gmail.com', 'phone': '+201558222026'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Ali Mahmoud Ali Elhewaity', 'investigatorAffiliation': 'Al-Azhar University'}}}}