[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655323":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":21,"studyPopulation":21,"armGroups":33,"interventions":44,"overallOfficials":21,"centralContacts":53,"locations":60,"responsibleParty":78,"collaborators":21,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":21,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":21,"enrollmentInfo":89,"targetDuration":21,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":21,"overallStatus":98,"whyStopped":21,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Alexandria University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Change in clinical attachment loss","Measurements will be recorded using a graduated William's periodontal probe","Baseline and 8 weeks",[14,16,18],{"measure":15,"description":11,"timeFrame":12},"Change in Probing Pocket Depth",{"measure":17,"description":11,"timeFrame":12},"Change in Bleeding on probing",{"measure":19,"description":20,"timeFrame":12},"Change in Melatonin levels in Gingival Crevicular Fluid","The collected GCF samples will be analyzed using a commercially available Enzyme-Linked Immunosorbent Assay (ELISA) kit specific for human melatonin",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":25,"primaryPurpose":26,"observationalModel":21,"timePerspective":21,"maskingInfo":27},"RANDOMIZED","PARALLEL","This is a randomised split-mouth clinical trial in which each participant receives both interventions.","TREATMENT",{"masking":28,"maskingDescription":21,"whoMasked":29},"TRIPLE",[30,31,32],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR",[34,39],{"label":35,"type":36,"description":21,"interventionNames":37},"Test Group","EXPERIMENTAL",[38],"Other: 2% Melatonin gel",{"label":40,"type":41,"description":21,"interventionNames":42},"Control","PLACEBO_COMPARATOR",[43],"Other: Placebo Gel",[45,49],{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":21},"2% Melatonin gel","All qualifying periodontal pockets on the randomly assigned test side will receive Non-Surgical Periodontal Therapy (NSPT) followed immediately by the subgingival application of 2% Melatonin gel.",[35],{"type":6,"name":50,"description":51,"armGroupLabels":52,"otherNames":21},"Placebo Gel","All qualifying periodontal pockets on the contralateral side will receive Non-Surgical Periodontal Therapy (NSPT) followed immediately by the subgingival application of the Placebo gel.",[40],[54],{"name":55,"role":56,"phone":57,"phoneExt":58,"email":59},"Nourhan Kamel, BDS","CONTACT","01147473085","002","nourhan.ezzeldin.dent@alexu.edu.eg",[61],{"facility":62,"status":21,"city":63,"state":21,"zip":21,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Outpatient Clinic of Periodontology and Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt","Alexandria","Egypt","EG",{"type":67,"coordinates":68},"Point",[69,70],29.91582,31.20176,{"lat":70,"lon":69},[73,76],{"name":74,"role":56,"phone":75,"phoneExt":21,"email":21},"Faculty of Dentistry","(203) 4868308",{"name":55,"role":77,"phone":21,"phoneExt":21,"email":21},"PRINCIPAL_INVESTIGATOR",{"type":79,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100655323","locally-delivered-melatonin-gel-in-management-of-stage-ii-grade-b-periodontitis-100655323",false,"NCT07813936","Locally Delivered Melatonin Gel in Management of Stage II Grade B Periodontitis","The Effect of Locally Delivered Melatonin Gel as an Adjunctive to Non-surgical Periodontal Therapy in the Management of Stage II Grade B Periodontitis: a Split-mouth Randomised Controlled Clinical Trial","Inclusion Criteria:\n\n* Systemically healthy patients diagnosed with Stage II Grade B Periodontitis\n* Patients with good oral hygiene compliance\n\nExclusion Criteria:\n\n* Smokers (due to the effect of smoking on melatonin levels and healing)\n* Pregnant or lactating females.\n* Patients who have received antibiotics, anti-inflammatory drugs, or antioxidant supplements within the last 6 months.\n* Patients taking systemic melatonin for sleep disorders.\n* Patients who have undergone periodontal therapy in the last 6 months.","ALL","18 Years",{"count":90,"type":91},23,"ESTIMATED","INTERVENTIONAL",[94],"NA","Background: Periodontitis is a chronic inflammatory disease characterized by the destruction of tooth-supporting tissues, driven by an imbalance between bacterial pathogens and the host immune response. This inflammatory process leads to the excessive production of reactive oxygen species (ROS), causing oxidative stress and tissue damage. Melatonin is a potent antioxidant and immunomodulator that scavenges free radicals and reduces inflammation. Previous research indicates that salivary and gingival crevicular fluid (GCF) melatonin levels are significantly reduced in patients with periodontitis compared to healthy individuals, suggesting its potential utility as a biomarker for periodontal health.\n\nAim: The aim of this study is to evaluate the efficacy of 2% melatonin gel administered locally into periodontal pockets as an adjunct to subgingival instrumentation in patients with Stage II Grade B periodontitis.",[97],"Periodontal Diseases","NOT_YET_RECRUITING","2026-09-06",{"date":101,"type":102},"2026-09-10","ACTUAL",{"date":101,"type":91},{"date":105,"type":91},"2027-09-30",{"name":5,"class":6},1]