[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620570":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":30,"locations":31,"responsibleParty":70,"collaborators":30,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":30,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":30,"enrollmentInfo":82,"targetDuration":30,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":34,"whyStopped":30,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Cairo University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Microneedling will be done with application of Platelet Rich Plasma for depigmentation.","EXPERIMENTAL","A Dermapen device will be used to microneedle the gingival tissue (model M8) with 24 microneedles arranged in rows, which is adjusted according to the gingival thickness at the 6th mode speed of 700 cycles\u002Fmin(Mostafa and Alotaibi 2022).\n\nIt will be laid perpendicular to gingival surface and MN will be carried out in horizontal, vertical and diagonal directions about four to five times for the whole hyperpigmented gingiva until mild microbleeding and mild erythema was clearly visible.\n\nOnce bleeding points are observed on all areas of the pigmented gingiva, it will be irrigated using saline solution and dried using sterile gauze.\n\nPatients receive injection of PRP in their Gingiva. To prepare PRP, 10mL of the patient's venous blood sample was taken manually with a sterile 10mL syringe and then centrifuged with 1300 RPM\u002F10min, buffy coat and plasma were then extracted and re-centrifuged with 2000 RPM\u002F10min. The injection of 1mL of PRP was immediately initiated .",[13],"Procedure: Microneedling will be done with application of Platelet Rich Plasma for depigmentation.",{"label":15,"type":16,"description":17,"interventionNames":18},"Microneedling will be done alone for Gingival depigmentation.","ACTIVE_COMPARATOR","A Dermapen device will be used to microneedle the gingival tissue (model M8) with 24 microneedles arranged in rows, which is adjusted according to the gingival thickness at the 6th mode speed of 700 cycles\u002Fmin(Mostafa and Alotaibi 2022).\n\nIt will be laid perpendicular to gingival surface and MN will be carried out in horizontal, vertical and diagonal directions about four to five times for the whole hyperpigmented gingiva until mild microbleeding and mild erythema was clearly visible.\n\nOnce bleeding points are observed on all areas of the pigmented gingiva, it will be irrigated using saline solution and dried using sterile gauze.",[19],"Procedure: Microneedling alone for Gingival Depigmentation.",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","A Dermapen device will be used to microneedle the gingival tissue (model M8) with 24 microneedles arranged in rows, which is adjusted according to the gingival thickness at the 6th mode speed of 700 cycles\u002Fmin(Mostafa and Alotaibi 2022). It will be laid perpendicular to gingival surface and MN will be carried out in horizontal, vertical and diagonal directions about four to five times for the whole hyperpigmented gingiva until mild microbleeding and mild erythema was clearly visible. Once bleeding points are observed on all areas of the pigmented gingiva, it will be irrigated using saline solution and dried using sterile gauze. Patients receive injection of PRP in their Gingiva. To prepare PRP, 10mL of the patient's venous blood sample was taken manually with a sterile 10mL syringe and then centrifuged with 1300 RPM\u002F10min, buffy coat and plasma were then extracted and re-centrifuged with 2000 RPM\u002F10min. The injection of 1mL of PRP was immediately initiated .",[9],[26],"PRP",{"type":22,"name":28,"description":17,"armGroupLabels":29,"otherNames":30},"Microneedling alone for Gingival Depigmentation.",[15],null,[32,52,64],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Cairo university","RECRUITING","Cairo","El Manial","11562","Egypt","EG",{"type":41,"coordinates":42},"Point",[43,44],31.24967,30.06263,{"lat":44,"lon":43},[47],{"name":48,"role":49,"phone":50,"phoneExt":30,"email":51},"Abdelrahman Sameer Abdullah, masters","CONTACT","+201275489234","abdelrhman-sameer@dentistry.cu.edu.eg",{"facility":53,"status":34,"city":35,"state":54,"zip":55,"country":38,"countryCode":39,"cosmosGeoPoint":56,"geoPoint":58,"contacts":59},"Faculity of Dentistry, Cairo university","El Manyl","11555",{"type":41,"coordinates":57},[43,44],{"lat":44,"lon":43},[60,61],{"name":48,"role":49,"phone":50,"phoneExt":30,"email":51},{"name":62,"role":63,"phone":30,"phoneExt":30,"email":30},"Abdelrahman Sameer Abdullah, Masters","PRINCIPAL_INVESTIGATOR",{"facility":53,"status":34,"city":35,"state":54,"zip":55,"country":38,"countryCode":39,"cosmosGeoPoint":65,"geoPoint":67,"contacts":68},{"type":41,"coordinates":66},[43,44],{"lat":44,"lon":43},[69],{"name":48,"role":49,"phone":50,"phoneExt":30,"email":51},{"type":63,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Abdelrahman Sameer Abdullah","principal investigator","100620570","microneedling-with-platelet-rich-plasma-versus-microneedling-alone-for-gingival-depigmentation-100620570",false,"NCT07359339","Microneedling With Platelet Rich Plasma Versus Microneedling Alone For Gingival Depigmentation","Microneedling With Platelet Rich Plasma Versus Microneedling Alone For Gingival Depigmentation: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* • Patients exhibiting melanin hyperpigmentation in the anterior region of the upper or lower gingiva.\n\n  * Age ≥ 18 year old.\n  * Patients should be free from any systemic diseases according to modified Cornell Medical index (Abramson 1966).\n  * Non- smokers\n\nExclusion Criteria:\n\n* • Fully edentulous patients.\n\n  * Patients with endocrine disorders causing hyperpigmentation or drug induced gingival pigmentation. (Sreeja, Ramakrishnan et al. 2015)\n  * Pregnant or lactating females.","ALL","18 Years",{"count":83,"type":84},32,"ESTIMATED","INTERVENTIONAL",[87],"NA","To evaluate the usage of microneedling with platelet rich plasma as a gingival depigmentation method in comparison to microneedling alone for pigment intensity reduction.\n\nPre-operative preparation phase includes ultrasonic scaling and oral hygiene instructions for all patients. Eligible patients will be randomly allocated into two groups.\n\nClinical photographs: Clinical photographs will be taken at baseline, 1 and 6 months postoperatively.\n\nIntervention Group (Group A): Microneedling will be done with application of Platelet Rich Plasma for depigmentation.\n\nControl Group (Group B): microneedling will be done alone for depigmentation.",[90],"Gingival Pigmentation",[92,93,26,94],"Pigmentation","Gingiva","Microneedling","2026-01-13",{"date":97,"type":98},"2026-01-22","ACTUAL",{"date":100,"type":98},"2025-10-01",{"date":102,"type":84},"2026-11-10",{"name":5,"class":6},3]