[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657892":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":27,"studyPopulation":18,"armGroups":28,"interventions":44,"overallOfficials":53,"centralContacts":58,"locations":18,"responsibleParty":64,"collaborators":18,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":66,"acronym":18,"eligibilityCriteria":72,"healthyVolunteers":69,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":18,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":93,"whyStopped":18,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":18},{"fullName":5,"class":6},"Mansoura University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Implant Stability Quotient (ISQ)","Primary implant stability will be measured using Resonance Frequency Analysis (RFA) and expressed as Implant Stability Quotient (ISQ) values.","Immediately after implant placement and follow up visits during the 6 months",[14],{"measure":15,"description":16,"timeFrame":17},"Marginal (crestal) bone level changes around the dental implants","assessed radiographically using standardized periapical radiographs during the 6-month follow-up period.","6 months",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":22,"primaryPurpose":23,"observationalModel":18,"timePerspective":18,"maskingInfo":24},"RANDOMIZED","PARALLEL","Participants will be randomly assigned into three parallel groups receiving different implant surface treatments prior to immediate loading in the posterior maxilla.","TREATMENT",{"masking":25,"maskingDescription":26,"whoMasked":18},"NONE","No masking will be applied in this study due to the nature of the surgical interventions.","Dental implants are a predictable treatment option for the replacement of missing teeth. However, implant placement in the posterior maxilla remains challenging because of reduced bone density, sinus pneumatization, and limited residual bone volume. Achieving adequate primary stability is particularly important when immediate loading protocols are used.\n\nBlue®M Gel is an oxygen-releasing topical gel that provides controlled delivery of active oxygen and contains lactoferrin, which may support wound healing, reduce bacterial load, and enhance tissue regeneration. Hyaluronic acid is a naturally occurring glycosaminoglycan that plays an important role in tissue repair, modulation of inflammation, and bone regeneration. Both materials have demonstrated beneficial effects on soft and hard tissue healing.\n\nThis study will be conducted as a randomized controlled clinical trial including patients requiring replacement of one or more missing teeth in the posterior maxilla. A total of 24 implants will be inserted and randomly allocated into three equal groups:\n\nGroup I: Immediate loaded implants without surface treatment (control group).\n\nGroup II: Immediate loaded implants immersed in Blue®M Gel before placement.\n\nGroup III: Immediate loaded implants immersed in hyaluronic acid gel before placement.\n\nAll implants will be placed using a standardized surgical protocol. Implant stability will be measured immediately after placement and at follow-up intervals using resonance frequency analysis and Implant Stability Quotient (ISQ) values. Clinical healing parameters will be evaluated postoperatively, including pain, edema, soft tissue inflammation, wound dehiscence, and signs of infection. Radiographic assessment of crestal bone level changes will be performed using CBCT imaging.\n\nThe primary objective of the study is to compare the effect of topical oxygen therapy and hyaluronic acid on implant stability in immediately loaded dental implants placed in the posterior maxilla. Secondary objectives include evaluation of peri-implant soft tissue healing and radiographic bone changes during the follow-up period.",[29,33,39],{"label":30,"type":31,"description":32,"interventionNames":18},"Control Group","NO_INTERVENTION","Patients will receive immediately loaded dental implants without any surface conditioning or immersion in adjunctive agents prior to placement in the posterior maxilla",{"label":34,"type":35,"description":36,"interventionNames":37},"Blue®M Gel Group","EXPERIMENTAL","Patients will receive immediately loaded dental implants immersed in topical oxygen therapy gel (Blue®M Gel) prior to placement in the posterior maxilla",[38],"Other: Blue®M Gel",{"label":40,"type":35,"description":41,"interventionNames":42},"Hyaluronic Acid Group","Patients will receive immediately loaded dental implants immersed in hyaluronic acid gel prior to placement in the posterior maxilla.",[43],"Other: Hyaluronic Acid",[45,49],{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":18},"Blue®M Gel","Topical oxygen-releasing gel used for implant surface conditioning prior to placement to enhance healing and implant stability.",[34],{"type":6,"name":50,"description":51,"armGroupLabels":52,"otherNames":18},"Hyaluronic Acid","Viscoelastic gel used for implant surface immersion prior to placement to enhance soft and hard tissue healing and improve implant stability.",[40],[54],{"name":55,"affiliation":56,"role":57},"Fahad A Alqahtani","Faculty of Dentistry, Mansoura University","PRINCIPAL_INVESTIGATOR",[59],{"name":60,"role":61,"phone":62,"phoneExt":18,"email":63},"Fahad A Alqahtani, BDS","CONTACT","+201558123728","fa.3wad@hotmail.com",{"type":57,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Fahad awad","Topical Oxygen Therapy (Blue®M Gel) Versus Hyaluronic Acid on the Stability of Immediately Loaded Dental Implants in the Posterior Maxilla","100657892","bluem-gel-versus-hyaluronic-acid-for-stability-of-immediately-loaded-dental-implants-100657892",false,"NCT07844928","Blue®M Gel Versus Hyaluronic Acid for Stability of Immediately Loaded Dental Implants","Inclusion Criteria:\n\n1. Patients aged 18-45 years.\n2. Patients with one or more missing teeth in the posterior maxilla.\n3. Adequate bone volume (width ≥ 6 mm and height ≥ 12 mm from maxillary sinus floor).\n4. Good oral hygiene and motivation for oral rehabilitation.\n\nExclusion Criteria:\n\n1. Patients with systemic or local diseases contraindicating implant surgery.\n2. Smokers.\n3. History of radiotherapy or chemotherapy.\n4. Pregnant.","ALL","18 Years","45 Years",{"count":77,"type":78},24,"ESTIMATED","INTERVENTIONAL",[81],"NA","This randomized controlled clinical trial aims to compare the effect of topical oxygen therapy (Blue®M Gel) and hyaluronic acid on the stability of immediately loaded dental implants placed in the posterior maxilla. Twenty-four dental implants will be placed in eligible patients and randomly assigned to one of three groups: control implants without surface treatment, implants immersed in Blue®M Gel before placement, and implants immersed in hyaluronic acid gel before placement.\n\nImplant stability will be evaluated using resonance frequency analysis immediately after implant placement and during follow-up. Clinical healing outcomes, including pain, edema, soft tissue inflammation, wound dehiscence, and signs of infection, will also be assessed. Radiographic evaluation of crestal bone level changes will be performed using cone beam computed tomography (CBCT). The study seeks to determine whether topical oxygen therapy or hyaluronic acid can improve implant stability and peri-implant healing in the posterior maxilla.",[84,85,86],"Dental Implants","Immediate Dental Implant Loading","Implant Stability",[46,88,50,89,90,91,92],"Topical Oxygen Therapy","Implant Stability Quotient","Osseointegration","CBCT Bone Level","Immediately Loaded Implants","NOT_YET_RECRUITING","2026-09-21",{"date":96,"type":97},"2026-09-28","ACTUAL",{"date":99,"type":78},"2026-09-12",{"date":101,"type":78},"2027-03-12",{"name":5,"class":6}]