[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624372":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":62,"collaborators":26,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":26,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":26,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Arab American University (Palestine)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Single-implant mandibular overdenture (parasymphyseal\u002Fcanine, preferred chewing side)","EXPERIMENTAL","One bone-level implant will be placed in the mandibular parasymphyseal\u002Fcanine region on the preferred chewing side using a single-stage approach. A locator-type attachment (Sonator S) will be connected according to the manufacturer's instructions, and intraoral pick-up will be performed with cold-curing resin.",[13],"Procedure: Single-implant mandibular overdenture (parasymphyseal\u002Fcanine region)",{"label":15,"type":16,"description":17,"interventionNames":18},"Two-implant mandibular overdenture (interforaminal)","ACTIVE_COMPARATOR","Two bone-level implants will be placed bilaterally in the mandibular interforaminal region (bilateral lateral incisor-canine area) using a single-stage approach. Locator-type attachments (Sonator S) will be connected according to the manufacturer's instructions, and intraoral pick-up will be performed with cold-curing resin.",[19],"Procedure: Two-implant mandibular overdenture (interforaminal)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Single-implant mandibular overdenture (parasymphyseal\u002Fcanine region)","Placement of one endosseous implant in the mandibular parasymphyseal\u002Fcanine region on the participant's preferred chewing side, followed by delivery of a mandibular overdenture retained with a standardized attachment protocol and follow-up schedule.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Placement of two endosseous implants in the mandibular interforaminal region (bilateral lateral incisor-canine area), followed by delivery of a mandibular overdenture retained with the same standardized attachment protocol and follow-up schedule.",[15],[31],{"name":32,"affiliation":33,"role":34},"Rola M Shadid, BDS, MSc","Arab American University","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+970594494066","rola.shadid@aaup.edu",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},"Jafar AbuAssba, BDS, MSc","00970598595800","jafar.abuassba@aaup.edu",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":26,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Faculty of Dentistry\u002F Arab American University","RECRUITING","Jenin","Palestine","240 jenin","Palestinian Territories",{"type":53,"coordinates":54},"Point",[55,56],35.30086,32.45943,{"lat":56,"lon":55},[59],{"name":60,"role":37,"phone":61,"phoneExt":26,"email":39},"Rola shadid","00970594494066",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Rola Shadid","Associate Professor, Department of Prosthodontics, Arab American University (Palestine)","100624372","single-implant-versus-two-implant-mandibular-overdentures-100624372",false,"NCT07408778","Single-implant Versus Two-implant Mandibular Overdentures","Patient-reported Outcomes and Masticatory Performance of Mandibular Overdentures Retained by One Parasymphyseal Implant or Two Implants: Randomized Clinical Trial","Inclusion Criteria:\n\n* Men and women ≥40 years.\n* ASA I-II; favorable general health or adequately controlled systemic disease (e.g., hypertension, diabetes).\n* Skeletal Class I relationship.\n* Completely edentulous mandible and maxilla.\n* Technically acceptable complete dentures in both jaws for ≥3 and ≤24 months; dissatisfaction limited to mandibular retention\u002Fstability.\n* Adequate anterior mandibular bone for implant ≥3.5×10 mm confirmed on CBCT; no bone augmentation needed.\n* Normal mucosal resilience (\\~2 mm displacement).\n* Implant sites healed ≥4 months since extraction.\n* Willingness to be randomized and attend follow-ups; written informed consent.\n* Primary stability target ≥25 N-cm.\n\nExclusion Criteria:\n\n* Uncontrolled systemic disease; neurodegenerative disease; osteoporosis requiring antiresorptives.\n* Chronic systemic antibiotics\u002Fsteroids; bleeding disorders; active cancer therapy; metabolic bone disease; HIV.\n* Investigational drug use within 30 days.\n* Alcohol dependence\u002Fillicit drug use; xerostomia (stimulated flow \\\u003C0.7 mL\u002Fmin).\n* Heavy smoking \\>20 cigarettes\u002Fday.\n* TMD\u002Forofacial pain; severe bruxism; moderate\u002Fsevere cognitive impairment.\n* Prior implant therapy.\n* Non-adherence risk or inability to attend longitudinal visits.\n* Insufficient prosthetic space for attachment housing: inter-arch vertical distance \\\u003C8.5 mm at parasymphyseal\u002Fcanine region.\n* Concurrent participation in another interventional study.\n* Erosive lichen planus or other significant oral mucosal disease; head-and-neck irradiation history.\n* Mandibular pathology on CBCT (e.g., cyst, tumor).\n* Ridge dimensions \\\u003C6 mm width or \\\u003C10 mm height at planned sites.\n* Active intraoral infection.","ALL","40 Years",{"count":76,"type":77},32,"ESTIMATED","INTERVENTIONAL",[80],"NA","This randomized controlled trial compares a mandibular overdenture retained by one implant placed in the parasymphyseal or canine region with a mandibular overdenture retained by two implants placed in the interforaminal region in completely edentulous adults. Primary outcomes are oral health-related quality of life, patient satisfaction, and masticatory performance measured by a two-color chewing gum mixing test, assessed at baseline before implant surgery and at 3, 6, and 12 months after overdenture insertion.",[83],"Edentulism",[85,86,87],"mandibular denture instability","poor denture retention","implant-retained overdenture","2026-02-16",{"date":90,"type":91},"2026-02-17","ACTUAL",{"date":88,"type":91},{"date":94,"type":77},"2027-07",{"name":64,"class":6},1]