[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654154":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":39,"studyPopulation":28,"armGroups":40,"interventions":59,"overallOfficials":78,"centralContacts":83,"locations":89,"responsibleParty":97,"collaborators":28,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":28,"eligibilityCriteria":106,"healthyVolunteers":107,"sex":108,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":28,"studyType":114,"phases":115,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":127,"whyStopped":28,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Sana'a University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Rate of clinical tooth movement via intraoral digital scans","Quantitative measurement of cumulative linear displacement and dental crown movement (in millimeters) calculated after every 2- aligners sequence (every 4 weeks) measurement will be obtained using digital intra-oral scan superimposed across all three study groups.","Every 4 weeks from baseline up to 6 months",[14,18,22,25],{"measure":15,"description":16,"timeFrame":17},"Root apex displacement","Assessment of root apex displacement in millimeters using CBCT superimposition","Baseline and 6 months",{"measure":19,"description":20,"timeFrame":21},"Patient-Reported Pain Level","Pain intensity is evaluated using the Visual Analog Scale from 0 to 10, where 0 indicates no pain and 10 represents the worst possible pain. Higher scores indicate worse pain.","At baseline, 24 hours, 48 hours, day 3, day 7 and day at aligner change up to 6 months.",{"measure":23,"description":24,"timeFrame":17},"Root resorption","Assessment of root resorption in millimeters using CBCT superimposition",{"measure":26,"description":27,"timeFrame":17},"Peri-tooth alveolar bone density","Assessment of peri-tooth alveolar bone density changes in Hounsfield Unit (HU) using CBCT superimposition.",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":32,"primaryPurpose":33,"observationalModel":28,"timePerspective":28,"maskingInfo":34},"RANDOMIZED","PARALLEL","Trial with three independent groups","TREATMENT",{"masking":35,"maskingDescription":36,"whoMasked":37},"SINGLE","This is a single-blind study. the outcome assessor and data analyst are blinded to group allocations. blinding the clinician and participants was not feasible due to the nature of PRP and photobiomodulation application.",[38],"OUTCOMES_ASSESSOR","This randomized controlled clinical trial evaluates the acceleration orthodontic tooth movement using two adjunct biological stimulation modalities in patients under going clear aligners therapy participant are allocated into three groups:\n\n1. Clear aligner + photobiomodulation (PBM) : receives low-level laser therapy at specific intervals to stimulate cellular turnover and bone remodeling\n2. Clear aligner +platelet-rich plasma (PRP) :receives localized autologous injections in the target tooth movement area to facilitate biological response\n3. Clear aligners alone: (control group )receiving standard clear aligners treatment without additional interventions.\n\nOutcomes will be evaluated periodically using digital intra-oral scanning to measure tracking, accuracy, rate of orthodontic tooth movement, and soft tissue - periodontal health throughout the active treatment period.",[41,48,53],{"label":42,"type":43,"description":44,"interventionNames":45},"Clear Aligner + Photobiomodulation","EXPERIMENTAL","under a reduced wear-time framework.",[46,47],"Device: photobiomodulation (PBM) Therapy","Device: clear aligner(12-hour wear protocol)",{"label":49,"type":43,"description":50,"interventionNames":51},"Clear Aligner + Plasma Injection","under a reduced wear-time framework",[52,47],"Biological: Platelet Rich Plasma (PRP) injection",{"label":54,"type":55,"description":56,"interventionNames":57},"Clear Aligner Control Group","ACTIVE_COMPARATOR","without any accelerator intervention",[58],"Device: Clear aligner(22-hour wear protocol)",[60,65,70,74],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":28},"BIOLOGICAL","Platelet Rich Plasma (PRP) injection","local submucosal injection of Autologous Platelet Rich Plasma (PRP) into the targeted alveolar site to evaluate its clinical effectiveness in accelerating orthodontic tooth movement",[49],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":28},"DEVICE","photobiomodulation (PBM) Therapy","extra-oral application of photobiomodulation (PBM) Therapy to the targeted alveolar site to evaluate its clinical effectiveness in accelerating orthodontic tooth movement",[42],{"type":66,"name":71,"description":72,"armGroupLabels":73,"otherNames":28},"clear aligner(12-hour wear protocol)","Clear aligner worn for 22-hour on the first day of each aligner stage, followed by a daily wear duration of 12-hour per day for the remaining period in combination with acceleration modalities",[42,49],{"type":66,"name":75,"description":76,"armGroupLabels":77,"otherNames":28},"Clear aligner(22-hour wear protocol)","Clear aligners worn for the standard conventional duration of 22-hour per day without additional acceleration interventions",[54],[79],{"name":80,"affiliation":81,"role":82},"Arij L Abdulmajid, MSc","Sanaa University","PRINCIPAL_INVESTIGATOR",[84],{"name":85,"role":86,"phone":87,"phoneExt":28,"email":88},"Naela M Al-mogahed, Prof","CONTACT","+967777962002","almogahed2000@yahoo.com",[90],{"facility":91,"status":28,"city":92,"state":93,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":28,"geoPoint":28,"contacts":28},"Faculty of Dentistry Sanaa university","Sanaa","Sanaa Governorate","009671","Yemen","YE",{"type":82,"investigatorFullName":98,"investigatorTitle":99,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Arij Lutf Abdulrhman Abdul Majid","PhD student","100654154","phase-1-acceleration-of-tooth-movement-using-prp-and-photobiomodulation-with-clear-aligners-100654154",false,"NCT07795073","Acceleration of Tooth Movement Using PRP and Photobiomodulation With Clear Aligners","Evaluation and Comparison of Acceleration of Tooth Movement Using Platelet-Rich Plasma (PRP) and Photobiomodulation (PBM) With Clear Orthodontic Appliances (Aligners): A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Age 18- 25 years requiring clear aligner therapy\n* good oral hygiene and health periodontal status\n* full permanent dentition (excluding third molars)\n* willingness to comply with clear aligner wear schedules and follow -up visits.\n\nExclusion Criteria:\n\n* history of previous orthodontic treatment\n* Systemic diseases or conditions affecting bone metabolism\n* Ongoing pharmacological treatment able to influence orthodontic movement (e.g. prostaglandin inhibitors or biphosphonates)\n* Active periodontal disease or poor oral hygiene\n* history of photosensitivity or diseases triggered by light exposure\n* contraindication to PRP blood extraction",true,"ALL","18 Years","25 Years",{"count":112,"type":113},42,"ESTIMATED","INTERVENTIONAL",[116,117],"PHASE1","PHASE2","This study compares the effectiveness of two adjunct therapies- photobiomodulation (low-level laser therapy) (PBM) and localized platelet-rich plasma (PRP) injections in accelerating orthodontic tooth movement. Participants receiving clear aligner therapy will be randomly assigned to one of three groups: clear aligners with PBM, clear aligners with PRP, or clear aligners alone (control group). The goal is to evaluate the efficiency, tooth movement tracking and safety.",[120],"Orthodontic Tooth Movement",[122,123,124,125,126],"clear aliginer","low- level laser therapy","PRP","Accelerated tooth movement","orthodontics","NOT_YET_RECRUITING","2026-08-26",{"date":130,"type":131},"2026-08-31","ACTUAL",{"date":133,"type":113},"2026-09-01",{"date":135,"type":113},"2027-05-01",{"name":5,"class":6},1]