[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659788":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":33,"studyPopulation":21,"armGroups":34,"interventions":47,"overallOfficials":21,"centralContacts":21,"locations":58,"responsibleParty":88,"collaborators":21,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":21,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":21,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":114,"overallStatus":61,"whyStopped":21,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Future University in Egypt","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":21},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change in Peri-Implant Bone Density","Change in peri-implant bone density measured in Hounsfield Units (HU) using Cone Beam Computed Tomography (CBCT) scan cross-sections at the peri-implant defect area.","Baseline (immediately post-operatively) and 6 months post-operatively.",{"measure":14,"description":15,"timeFrame":12},"Change in Buccal Bone Thickness","Change in buccal bone plate thickness measured in millimeters (mm) on CBCT cross-sectional views at predefined levels relative to the implant shoulder.",[17],{"measure":18,"description":19,"timeFrame":20},"Change in Primary and Secondary Implant Stability","Implant stability measured using the AnyCheck device on the Implant Stability Test (IST) scale. IST values range from 30 to 99, where higher values indicate higher implant stability.","Baseline (immediately after implant insertion), 1.5 months, and 3 months post-operatively.",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":25,"primaryPurpose":26,"observationalModel":21,"timePerspective":21,"maskingInfo":27},"RANDOMIZED","PARALLEL","Participants will be randomly allocated into two parallel groups in a 1:1 ratio. Group A (Intervention) will receive an immediate dental implant with the application of 1% w\u002Fw melatonin gel into the extraction socket. Group B (Control) will receive an immediate dental implant using the same standard surgical protocol without the application of melatonin gel.","TREATMENT",{"masking":28,"maskingDescription":29,"whoMasked":30},"DOUBLE","Participants are blinded to group assignment. To eliminate measurement bias during outcome evaluation, CBCT DICOM files and clinical records are coded and anonymized by an independent colleague prior to analysis. The principal investigator performs all radiographic measurements (bone density in HU and buccal bone thickness in mm) and IST stability evaluations while blinded to group allocation. The operating surgeon is unblinded during surgery due to procedural necessity.",[31,32],"PARTICIPANT","OUTCOMES_ASSESSOR","This study is a pilot randomized controlled clinical trial conducted at Future University in Egypt. Given the technical complexity of immediate implant placement in the posterior mandible combined with customized healing abutments, this pilot study evaluates a sample of 16 participants (8 per group) to assess protocol feasibility, evaluate soft-tissue healing profiles, and estimate outcome variability.\n\nStudy Design \\& Intervention:\n\n* Participants: Healthy adults (20-50 years) requiring immediate molar implant placement in the posterior mandible.\n* Test Group: Immediate implant placement with application of 1% w\u002Fw topical melatonin gel into the peri-implant socket gap.\n* Control Group: Immediate implant placement using standard surgical protocol without melatonin gel.\n* Socket Management: Both groups utilize a customized healing abutment to seal the socket.\n\nOutcome Assessment:\n\n* Radiographic Outcomes: Bone density (in Hounsfield Units, HU) and buccal bone thickness (in mm) measured via Cone Beam Computed Tomography (CBCT) at baseline, immediately postoperatively, and at 6 months.\n* Clinical Outcomes: Implant stability measured via AnyCheck (IST values) at placement, 1.5 months, and 3 months.\n* Feasibility \\& Safety: Evaluation of post-operative soft-tissue\u002Ffascia healing around customized healing abutments and surgical procedure feasibility.",[35,42],{"label":36,"type":37,"description":38,"interventionNames":39},"Melatonin Group","EXPERIMENTAL","Participants undergo immediate dental implant placement in the posterior mandible with application of 1% w\u002Fw melatonin gel into the extraction socket gap prior to implant insertion, sealed with a customized healing abutment.",[40,41],"Drug: 1% w\u002Fw Melatonin Gel","Procedure: Standard Immediate Dental Implant Placement",{"label":43,"type":44,"description":45,"interventionNames":46},"Control Group","ACTIVE_COMPARATOR","Participants undergo immediate dental implant placement in the posterior mandible following standard surgical protocol without melatonin gel application, sealed with a customized healing abutment.",[41],[48,53],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":21},"DRUG","1% w\u002Fw Melatonin Gel","Topical application of 1% w\u002Fw melatonin gel into the peri-implant socket gap immediately prior to dental implant insertion.",[36],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":21},"PROCEDURE","Standard Immediate Dental Implant Placement","Standard surgical placement of an immediate dental implant into a fresh extraction socket in the posterior mandible, using a customized healing abutment to seal the socket.",[43,36],[59],{"facility":60,"status":61,"city":62,"state":21,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine - Future University in Egypt","RECRUITING","Cairo","43528","Egypt","EG",{"type":67,"coordinates":68},"Point",[69,70],31.24967,30.06263,{"lat":70,"lon":69},[73,78,81,84,86],{"name":74,"role":75,"phone":76,"phoneExt":21,"email":77},"George Waleed Alhajj, B.D.S","CONTACT","+201550820559","georgealhajj1@gmail.com",{"name":79,"role":80,"phone":21,"phoneExt":21,"email":21},"George Waleed Alhajj, BDS, MSc Candidate.","PRINCIPAL_INVESTIGATOR",{"name":82,"role":83,"phone":21,"phoneExt":21,"email":21},"Lobna Abdelaziz, Professor, PhD","SUB_INVESTIGATOR",{"name":85,"role":83,"phone":21,"phoneExt":21,"email":21},"Amr Maged, Associate Professor, PhD",{"name":87,"role":83,"phone":21,"phoneExt":21,"email":21},"Aya Magdy Abdel Rady, Lecturer, PhD",{"type":80,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"George Waleed Alhajj","Postgraduate Researcher, Department of Oral and Maxillofacial Surgery.","100659788","melatonin-effect-on-immediate-dental-implants-in-the-posterior-mandible-a-pilot-study-100659788",false,"NCT07869030","Melatonin Effect on Immediate Dental Implants in the Posterior Mandible: A Pilot Study","Clinical and Radiographic Assessment of the Osteogenic Effect of Melatonin in Immediate Implant Placement: A Pilot Randomized Clinical Trial.","Inclusion Criteria:\n\n* Patients aged 20-50 years.\n* Indicated for extraction and immediate implant placement in the posterior mandibular molar region.\n* Good oral hygiene and compliance with postoperative instructions.\n* Non-smokers or light smokers (≤10 cigarettes\u002Fday).\n* Patients who provide written informed consent and agree to attend follow-up visits.\n\nExclusion Criteria:\n\n* Patients with systemic diseases affecting bone metabolism or wound healing (e.g., uncontrolled diabetes, osteoporosis).\n* Heavy smokers (\\>10 cigarettes\u002Fday).\n* History of head and neck radiotherapy or chemotherapy.\n* Pregnant or lactating women.\n* Sites with acute infection, cystic lesions, or pathology.\n* Bruxism or parafunctional habits.\n* Use of medications affecting bone turnover (e.g., bisphosphonates, corticosteroids).\n* Poor compliance or unwillingness to return for follow-up visits.","ALL","20 Years","50 Years",{"count":102,"type":103},16,"ESTIMATED","INTERVENTIONAL",[106],"NA","This pilot randomized controlled clinical trial aims to evaluate the feasibility, clinical safety, and preliminary radiographic osteogenic effects of applying topical 1% w\u002Fw melatonin gel during immediate implant placement in the posterior mandible. The study assesses surgical feasibility, soft-tissue healing, bone density, buccal bone thickness, and implant stability to provide preliminary effect size and variance estimates to inform future definitive clinical trials.",[109,110,111,112,113],"Dental Implant","Immediate Dental Implant Placement","Alveolar Bone Loss","Bone Density","Osseointegration",[115,116,113,117,118,119,112,120,121,122,123,124,125],"Melatonin","Immediate Implant Placement","AnyCheck","Implant Stability Test","IST","Dental Implants","Alveolar Bone","Posterior Mandible","Buccal Bone Thickness","Pilot Study","Customized Healing Abutment","2026-10-06",{"date":128,"type":129},"2026-10-09","ACTUAL",{"date":131,"type":129},"2025-11-06",{"date":133,"type":103},"2027-06",{"name":5,"class":6},1]