[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637285":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":43,"responsibleParty":61,"collaborators":64,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":26,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":26,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Cairo University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm1:(Vit C & glutathione injection)","EXPERIMENTAL","The site of interest will be anesthetized using topical anesthetic agent (lignocaine gel or xylocaine gel). Infiltration anesthesia will be recommended during the first injection visit. Intraepidermal injection of 1-1.5 ml of vitamin C and glutathione will be performed. It will be locally introduced in relation to the keratinized gingival tissues with extension to the whole target region successively using special syringes (50 gauge).\n\nThe needle will be introduced parallel to the gingival tissues with the bevel facing upwards. Vitamin C \\& glutathione will then be delivered through the attached gingival tissues at the epithelium-connective tissue junction (equivalent to epidermal- dermal junction) till the tissues blanch. Maximum 0.1 ml of injection is recommended for each point with 2-3 mm apart. The same dose will be repeated once per week for maximum 4 visits till no further color improvement gained.",[13],"Drug: Vitamin c and glutathione",{"label":15,"type":16,"description":17,"interventionNames":18},"ATM 2: surgical depigmentation","ACTIVE_COMPARATOR","Using a 15c blade an epithelial layer and part of connective tissue will be removed till the pigmentation disappears with ultra care not to expose the bone. The marginal and interdental papillary tissues remain critical regions, fortunately, they are not deeply pigmented. Periodontal dressing is recommended for minimal 7 days postoperative.\n\nPatients will be instructed to avoid the mechanical trauma to the treated sites. Patients will be administering an analgesic (Ibuprofen 400 mg) to be used as needed. Following each injection visit, the patients will be asked to abstain from mechanical oral hygiene procedures in relation to the target region for the day of procedure only. Plain tooth pastes (Colgate toothpaste) with anti- inflammatory mouthwash (Citrolin mouth, Pharco Company, Egypt) were recommended.",[19],"Procedure: Surgical depigmentation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Vitamin c and glutathione","Vitamins c and glutathione injection that usually used for cosmetic skin care (whitening)",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Surgical depigmentation","Removal of gingival pigmentation by scalpel",[15],[33],{"name":34,"affiliation":35,"role":36},"Nourhan A Abdullah, Phd","Lecturer at faculty of dentistry, Fayoum university","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":26,"email":42},"Nourhan A Abdelkhalek","CONTACT","01005802478","naa14@fayoum.edu.eg",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Faculty of Dentistry","RECRUITING","Al Fayyum","Faiyum Governorate","63511","Egypt","EG",{"type":53,"coordinates":54},"Point",[55,56],30.8418,29.30995,{"lat":56,"lon":55},[59],{"name":60,"role":40,"phone":26,"phoneExt":26,"email":26},"Amr E Emaraa, Associate professor",{"type":36,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Nourhan Abdallah Abdelkhalek","Doctor",[65],{"name":66,"class":6},"Fayoum University","100637285","phase-2-gingival-hyperpigmentation-treatment-100637285",false,"NCT07595705","Gingival Hyperpigmentation Treatment","Gingival Hyperpigmentation Treatment With Injectable Vitamin C in Conjunction With Glutathione Versus The Conventional Surgical Depigmentation: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\nThe selection criteria were done according to Gingival pigmentation index is as follows (Dummett and Bolden)10:\n\n1. Score0:absence of pigmentation\n2. Score1:spotsofbrowntoblackcolororpigments\n3. Score2:browntoblackpatchesbutnotdiffusepigmentation\n4. Score3:diffuse brown to black pigmentation,marginal,and attached.\n\nPatients who have Dummett and Bolden index score 1, 2, or 3 will be included in addition to the following criteria:\n\n1. above 18yrs\n2. systemically free\n3. physiologic gingival hyperpigmentation related to esthetic region\n4. well maintained oral hygiene and willing to undergo minor surgical procedures\n\nExclusion Criteria:\n\n1. systemic diseases associated with pathological hyperpigmentation or improper delayed wound healing (uncontrolled diabetes, autoimmune diseases, etc.)\n2. pregnant and lactating mothers\n3. usage of chlorhexidine or povidone iodine\n4. Local causes (smoking)\n5. periodontal diseases (plaque and non-plaque induced gingivitis or periodontitis)\n6. non compliant patients",true,"ALL","18 Years",{"count":78,"type":79},30,"ESTIMATED","INTERVENTIONAL",[82],"PHASE2","It is a clinical study conducted to evaluate the effect of vitamin C and Glucathonine injection of pigmented gingival tissue versus surgical removal by scalpel",[85,86,87,88],"Gingival Pigmentation","Depigmentation","Vitamin C","Glutathione",[90,91,92,93],"depigmentation","vit c","glutathione","gingival depigmentation","2026-05-15",{"date":96,"type":97},"2026-05-19","ACTUAL",{"date":99,"type":97},"2025-08-01",{"date":101,"type":79},"2027-10",{"name":5,"class":6},1]