[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598325":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":45,"centralContacts":50,"locations":31,"responsibleParty":60,"collaborators":31,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":31,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":31,"studyType":77,"phases":78,"briefSummary":81,"conditions":82,"keywords":31,"overallStatus":84,"whyStopped":31,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":31},{"fullName":5,"class":6},"Fayoum University","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Microneedling with vitamin C","ACTIVE_COMPARATOR","Prior to the MN procedure, local infiltration anesthesia will be administered as used in control group b) MN will be achieved using a Dermapen device. \\*\\*\\* c) The device allows for adjustable penetration depth, ranging from 0.2 mm to 3 mm, based on the gingival thickness. d) The needle tip comprises 12 to 24 needles arranged in rows, providing six-speed modes that span from 412 cycles\u002Fmin at the lowest speed to 700 cycles\u002Fmin at the highest speed. e) The Dermapen will be positioned perpendicular to the gingival surface, and microneedling will be executed horizontally, vertically, and diagonally approximately four to five times f) Across the entire hyperpigmented gingival surface until subtle microbleeding and mild erythema became evident. g) Topical ascorbic acid powder \\*\\*\\*\\*, (1,000 mg\u002FmL) mixed with saline will be applied over the gingiva for 10 minutes. h) Each individual will be undergoing a total of three treatment sessions of microneedling, spaced out by 10 days",[13,14],"Drug: Vitamin C","Device: Microneedling",{"label":16,"type":10,"description":17,"interventionNames":18},"Diode laser","Topical anesthetic spray will be applied to the operating area. Energy output, pulse duration, and focal distance will be determined based on manufactures instruction. b) Patient, doctor and assistant will wear protective glass before starting the procedure. c) Depigmentation will be carried out using semiconductor Sirolaser BlueWith proper isolation, depigmentation procedure will be done. e) Laser ablation will be started from the mucogingival junction toward the free gingival margin, including interdental papilla. f) The laser beam will be applied using the \"brush technique,\" as described by Tal (Tal et al.,2003) and the tip will be kept in motion all the time. g) Remnants of the ablated tissue will be removed using sterile gauze dampened with saline solution",[19],"Device: Diode laser",{"label":21,"type":10,"description":22,"interventionNames":23},"scalpal surgery","Local anesthesia will be administered through infiltration (2% lidocaine with epinephrine 1:100,000) \\* at the surgical site. b) Employing surgical blade number 15c, the gingival epithelium in the pigmented area will be excised. c) The blade will be oriented roughly parallel to the elongated axis of the teeth. d) A meticulous assessment of the revealed connective tissue surface will be performed, and any residual tissue tags will be removed with surgical scissors. e) Hemorrhage control will be managed by applying a pressure pack, and after achieving hemostasis, a periodontal dressing (a non-eugenol zinc oxide dressing) will be administered to cover the wound for one week",[24],"Procedure: scalpal",[26,32,37,40],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Vitamin C","Topical ascorbic acid powder, (1,000 mg\u002FmL) mixed with saline will be applied over the gingiva for 10 minutes.",[9],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"DEVICE","Microneedling","MN will be achieved using a Dermapen device. c) The device allows for adjustable penetration depth, ranging from 0.2 mm to 3 mm, based on the gingival thickness. d) The needle tip comprises 12 to 24 needles arranged in rows, providing six-speed modes that span from 412 cycles\u002Fmin at the lowest speed to 700 cycles\u002Fmin at the highest speed. e) The Dermapen will be positioned perpendicular to the gingival surface, and microneedling will be executed horizontally, vertically, and diagonally approximately four to five times f) Across the entire hyperpigmented gingival surface until subtle microbleeding and mild erythema became evident Each individual will be undergoing a total of three treatment sessions of microneedling, spaced out by 10 days",[9],{"type":33,"name":16,"description":38,"armGroupLabels":39,"otherNames":31},"Energy output, pulse duration, and focal distance will be determined based on manufactures instruction. b) Patient, doctor and assistant will wear protective glass before starting the procedure. c) Depigmentation will be carried out using semiconductor Sirolaser Blue With proper isolation, depigmentation procedure will be done. e) Laser ablation will be started from the mucogingival junction toward the free gingival margin, including interdental papilla. f) The laser beam will be applied using the \"brush technique,\" as described by Tal (Tal et al.,2003) and the tip will be kept in motion all the time. g) Remnants of the ablated tissue will be removed using sterile gauze dampened with saline solution",[16],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":31},"PROCEDURE","scalpal","Employing surgical blade number 15c, the gingival epithelium in the pigmented area will be excised. c) The blade will be oriented roughly parallel to the elongated axis of the teeth. d) A meticulous assessment of the revealed connective tissue surface will be performed, and any residual tissue tags will be removed with surgical scissors. e) Hemorrhage control will be managed by applying a pressure pack, and after achieving hemostasis, a periodontal dressing (a non-eugenol zinc oxide dressing) will be administered to cover the wound for one week.",[21],[46],{"name":47,"affiliation":48,"role":49},"Rehab Ahmed Dr\u002F Rehab Ahmed Osman, Lecturer","faculty of dentistry Fayoum university","STUDY_DIRECTOR",[51,56],{"name":52,"role":53,"phone":54,"phoneExt":31,"email":55},"Asmaa Eid Abdelal, resident","CONTACT","+0201025041804","asmaaeid402@gmail.com",{"name":57,"role":53,"phone":58,"phoneExt":31,"email":59},"Rehab Ahmed Osman, Lecturer","+0201153832971","rau11@fayoum.edu.eg",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Asmaa Eid Ragab Abdelal","Resident at oral medicine and periodontology department Fayoum university","100598325","phase-1-efficacy-of-microneedling-with-vitamin-c-in-performing-gingival-depigmentation-100598325",false,"NCT07070024","Efficacy of Microneedling With Vitamin C in Performing Gingival Depigmentation","Efficacy of Microneedling With Vitamin C in Performing Gingival Depigmentation Compared With Conventional Scalpel and Diode Laser: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Patients with bilateral, diffuse and symmetric physiologic gingival pigmentation in the labial maxillary or mandible gingiva.\n2. Patients free from any systemic diseases according to criteria of Modified Cornell Medical Index. (Abramson J et al., 1966)\n3. Periodontally healthy patient.\n4. Patients with age between 18 and 50 years\n\nExclusion Criteria:\n\n1. Smokers.\n2. Drugs intake \"mainly those associated with gingival pigmentation\".\n3. Pregnant and lactating women.\n4. Patients with thin gingival phenotype \"with scalpel group\".\n5. Gingival pigmentation associated with occupational hazards.\n6. Individuals undergoing chemotherapy","ALL","18 Years","50 Years",{"count":75,"type":76},30,"ESTIMATED","INTERVENTIONAL",[79,80],"PHASE1","PHASE2","The present study will be carried to clinically evaluate the efficacy of microneedling with vitamin C in performing gingival depigmentation in comparison with conventional scalpel and diode laser.",[83],"Gingival Pigmentation","NOT_YET_RECRUITING","2025-07-15",{"date":87,"type":88},"2025-07-17","ACTUAL",{"date":90,"type":76},"2025-07",{"date":92,"type":76},"2026-12",{"name":5,"class":6}]