[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593906":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":46,"responsibleParty":63,"collaborators":25,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":25,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":84,"conditions":85,"keywords":25,"overallStatus":87,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Dar Al Uloom University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Photobiomodulation + Hyaluronic Acid","EXPERIMENTAL","This arm includes the test sites (e.g., left maxillary quadrant) in each participant. The same dose of hyaluronic acid (0.2 mL of 0.8% gel) will be injected in the same manner as in the control group. However, photobiomodulation therapy (PBMT) using a diode laser (wavelength 630-670 nm, 25 mW, 1.875 J\u002Fcm² for 20 seconds) will be applied before and after the injection. Laser application will be repeated at every follow-up appointment to promote tissue healing, angiogenesis, and papillary regeneration.",[13],"Procedure: Photobiomodulation Therapy + Hyaluronic Acid Gel Injection",{"label":15,"type":16,"description":17,"interventionNames":18},"Hyaluronic Acid Gel Injection only","ACTIVE_COMPARATOR","This arm includes the control sites (e.g., right maxillary quadrant) in each participant. The interdental papilla with Class I deficiency will be treated using 0.2 mL of 0.8% commercial hyaluronic acid gel, injected 2-3 mm apical to the papilla tip. This is a commonly used non-surgical soft tissue filler in periodontal and esthetic procedures. No photobiomodulation therapy will be applied in this arm.",[19],"Drug: Hyaluronic Acid Gel Injection",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Photobiomodulation Therapy + Hyaluronic Acid Gel Injection",[9],null,{"type":27,"name":28,"description":17,"armGroupLabels":29,"otherNames":25},"DRUG","Hyaluronic Acid Gel Injection",[15],[31],{"name":32,"affiliation":33,"role":34},"SREIC College of dentistry, Dar AlUloom University","College of Dentistry, Dar AlUloom University, SA","STUDY_DIRECTOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Sally A ElHaddad, Assist. Prof.","CONTACT","+966555361062","s.elhaddad@dau.edu.sa",{"name":42,"role":38,"phone":43,"phoneExt":44,"email":45},"SREIC Scientific Research Ethics and Innovative committee","00966011494","9212","cod.sreic@du.edu.sa",[47],{"facility":48,"status":25,"city":49,"state":25,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"College of Dentistry, Dar AlUloom University","Riyadh","11512","Saudi Arabia","SA",{"type":54,"coordinates":55},"Point",[56,57],46.72185,24.68773,{"lat":57,"lon":56},[60],{"name":61,"role":38,"phone":62,"phoneExt":25,"email":40},"Sally ElHaddad, Assist. Prof.","00966555361062",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Sally Abd-ElMeniem ElHaddad","Assist. Prof. Periodontology and Oral Medicine","100593906","phase-1-clinical-evaluation-of-photobiomodulated-hyaluronic-acid-therapy-for-interdental-papillary-loss-minimal-invasive-blind-split-mouth-technique-100593906",false,"NCT07012525","Clinical Evaluation of Photobiomodulated Hyaluronic Acid Therapy for Interdental Papillary Loss: Minimal Invasive Blind Split Mouth Technique","Inclusion Criteria:\n\n* Adults aged 20 to 40 years\n* Presence of at least two non-adjacent interdental papilla defects (Class I, Norland \\& Tarnow classification) in the maxillary anterior region\n* Healthy periodontal status, with:\n* Probing depth ≤ 3 mm\n* No gingival recession\n* No tooth mobility (Score 0)\n* No interdental bone loss on radiographs\n* Non-smokers\n* No previous orthodontic treatment\n* Free from gingival or dental surface alterations (e.g., abfraction, irregularities, or overcontouring)\n* Systemically healthy (no systemic diseases or conditions affecting healing or immune function)\n* Willing and able to comply with study procedures and follow-up visits\n* Provided written informed consent after explanation of study procedures\n\nExclusion Criteria:\n\n* Candidates will be excluded if they meet any of the following:\n* Systemic diseases or medications known to affect soft tissue healing (e.g., diabetes, immunosuppressants)\n* Pregnancy or lactation\n* History of periodontal surgery in the study area\n* Known allergy or hypersensitivity to hyaluronic acid or local anesthetics\n* Current use of anti-inflammatory drugs, anticoagulants, or antibiotics that could affect healing\n* Poor oral hygiene or non-compliance during pre-treatment phase\n* Participation in another clinical trial within the last 3 months",true,"ALL","20 Years","40 Years",{"count":78,"type":79},14,"ESTIMATED","INTERVENTIONAL",[82,83],"PHASE1","PHASE2","The goal of this clinical trial is to evaluate the effectiveness of a minimally invasive therapy combining photobiomodulation (PBMT) with injectable dermal filler (hyaluronic acid) in adult patients (ages 20-40) with interdental papillary loss (Norland \\& Tarnow Class I) in the maxillary anterior region.\n\nThe main questions it aims to answer are:\n\nDoes PBMT enhance the regenerative effect of hyaluronic acid filler in restoring the interdental papilla? Is the combined therapy superior to dermal filler alone in achieving long-term aesthetic and clinical stability?\n\nResearchers will compare:\n\nGroup I (control) - hyaluronic acid filler alone vs. Group II (experimental) - PBMT applied before and after hyaluronic acid filler to see if PBMT contributes to better papilla height, width, and volume restoration over 12 months.\n\nParticipants will:\n\nUndergo standard periodontal cleaning and education 4 weeks before treatment Receive local anesthesia and dermal filler injections in both quadrants (split-mouth design)\n\nHave PBMT applied in one quadrant only (Group II) Be followed up at regular intervals (1 week to 12 months) for clinical measurements and digital image analysis of papilla dimensions This study introduces a non-surgical, patient-friendly technique that may enhance soft tissue regeneration in esthetic areas, offering a potential breakthrough in managing interdental papillary loss.",[86],"Interdental Papillae Reconstruction","NOT_YET_RECRUITING","2025-08-18",{"date":90,"type":91},"2025-08-22","ACTUAL",{"date":93,"type":79},"2025-09-15",{"date":95,"type":79},"2026-12-30",{"name":5,"class":6},1]