[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639363":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":38,"centralContacts":42,"locations":48,"responsibleParty":63,"collaborators":30,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":30,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":30,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":92,"whyStopped":30,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Qassim University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"3D-Printed Custom Space Maintainer","EXPERIMENTAL","Participants in this arm receive a custom-designed space maintainer fabricated through a fully digital workflow. This involves an intraoral scan (3Shape TRIOS) and CAD design (exocad). The appliance is 3D-printed using stereolithography (SLA) technology (Formlabs Form 3B+) with BioMed Clear Resin, a biocompatible photopolymer. The appliance is bonded to the abutment tooth using a light-cured orthodontic adhesive during a single or subsequent clinical visit.",[13],"Device: 3D-Printed Custom Space Maintainer",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Band-and-Loop","ACTIVE_COMPARATOR","This arm represents the current clinical reference standard. Fabrication follows a traditional analog workflow beginning with an alginate impression and stone model. A stainless steel band (3M Unitek) is fitted to the model, and a stainless steel wire (0.036-inch) is hand-contoured and silver-soldered to the band. The completed appliance is polished and cemented using glass ionomer cement in a second clinical appointment.",[19],"Device: Conventional Band-and-Loop Space Maintainer",{"label":21,"type":16,"description":22,"interventionNames":23},"Denovo Chairside Space Maintainer","This arm utilizes a prefabricated, chairside system (Denovo Dental) designed for single-visit delivery. A pre-sized stainless steel band is selected and fitted directly to the patient's tooth. A pre-formed wire loop is then adjusted for the appropriate span and mechanically secured to the band using a specialized crimping and locking tool, eliminating the need for laboratory soldering. The appliance is cemented during the same appointment as the initial fitting.",[24],"Device: Denovo Chairside Space Maintainer",[26,31,35],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","A digitally designed, monolithic space maintainer. The workflow involves an intraoral scan (3Shape TRIOS) and CAD design (exocad). The device is fabricated using stereolithography (SLA) technology (Formlabs Form 3B+) with BioMed Clear Resin. It is bonded to the abutment tooth using a light-cured orthodontic adhesive",[9],null,{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Conventional Band-and-Loop Space Maintainer","The traditional clinical reference standard. It is fabricated using an analog workflow: an alginate impression is taken to create a stone model, a stainless steel band (3M Unitek) is fitted to the model, and a 0.036-inch stainless steel wire is hand-contoured and silver-soldered to the band. The appliance is polished and cemented with glass ionomer cement.",[15],{"type":27,"name":21,"description":36,"armGroupLabels":37,"otherNames":30},"A prefabricated, stainless steel space maintainer system (Denovo Dental) designed for immediate application. A pre-sized band is selected and fitted directly to the patient's tooth. A pre-formed wire loop is adjusted for length at the chairside and mechanically secured to the band using a specialized crimping and locking tool, requiring no laboratory soldering. It is cemented during the initial appointment.",[21],[39],{"name":40,"affiliation":5,"role":41},"MURAD ALRASHIDI, BDS, MSC","PRINCIPAL_INVESTIGATOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":30,"email":47},"MURAD A ALRASHIDI, Pediatric Orthodontist","CONTACT","+966 55 302 2773","MU.ALRASHIDI@qu.edu.sa",[49],{"facility":5,"status":30,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Buraidah","Al-Qassim Region","52571","Saudi Arabia","SA",{"type":56,"coordinates":57},"Point",[58,59],43.97497,26.32599,{"lat":59,"lon":58},[62],{"name":40,"role":45,"phone":46,"phoneExt":30,"email":47},{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","Murad Alrashidi","Assistant Professor Orthodontics and Pediatric Dentistry","100639363","3d-printed-versus-band-and-loop-versus-denovo-space-maintainers-in-primary-dentition-100639363",false,"NCT07613658","3D-Printed Versus Band-and-Loop Versus Denovo Space Maintainers in Primary Dentition.","3D-Printed Custom Versus Conventional Band-and-Loop Versus Chairside Denovo Space Maintainers in the Primary Dentition: A Randomized Controlled Trial Protocol","Inclusion Criteria:\n\n1. Children aged 5 to 10 years\n2. Premature unilateral loss of at least one primary first or second molar\n3. Radiographically confirmed developing permanent successor at Nolla developmental stage 4 to 7\n4. Parent or legal guardian able and willing to provide written informed consent, and child able to provide age-appropriate assent\n\nExclusion Criteria:\n\n1. Systemic disease affecting bone metabolism or tooth development\n2. Clinically significant mesiodistal space loss at screening, defined as greater than 3 mm\n3. Poor oral hygiene precluding band placement, defined as a full-mouth plaque score greater than 50%\n4. Known allergy or hypersensitivity to stainless steel or resin components\n5. Current participation in another interventional clinical trial",true,"ALL","5 Years","10 Years",{"count":79,"type":80},360,"ESTIMATED","INTERVENTIONAL",[83],"NA","Purpose of the Study When a child loses a \"baby\" molar early due to a cavity or injury, the surrounding teeth can shift into the empty space. This often blocks the permanent adult tooth from growing in correctly. To prevent this, dentists use a small metal device called a space maintainer.\n\nThis study aims to find out which of three different types of space maintainers lasts the longest, is most comfortable for the child, and is most efficient for the dental office to provide.\n\nThe Three Study Groups\n\nChildren in this study are randomly assigned to one of three groups:\n\n1. 3D-Printed Custom Group: The dentist takes a digital picture (scan) of the child's mouth instead of a traditional mold. A custom-fit appliance is then 3D-printed using a specialized, medical-grade clear material.\n2. Conventional Band-and-Loop Group: This is the traditional method. The dentist takes a physical mold of the teeth, which is sent to a laboratory. The child usually has to return for a second appointment a week later to have the metal appliance glued into place.\n3. Denovo Chairside Group: This uses a kit of pre-made metal parts. The dentist selects the best fit and assembles the appliance right at the chairside, allowing it to be placed during a single visit.\n\nWhat is Being Measured?\n\nResearchers are following the children for 12 months to track:\n\nSurvival: Which appliance stays glued in and doesn't break most effectively?\n\nTime: How much time does the dentist spend making and fitting the appliance?\n\nComfort: How much discomfort or pain did the child feel during the process?\n\nHealth: Does the appliance cause any irritation to the gums or surrounding teeth?\n\nWho Can Participate? The study includes children between the ages of 5 and 10 who have lost at least one primary (baby) molar early and need a space maintainer to protect their future adult smile.\n\nImportance of This Research By comparing these three methods, this study helps dentists understand if newer technologies, like 3D printing or pre-made kits, are better or more convenient than the traditional lab-made metal loops used for decades. This information will help families choose the best treatment for their children.",[86,87],"Space Maintenance","Tooth Loss \u002F Rehabilitation",[86,89,90,91],"Band and Loop","3D-Printed Space Maintainer","Denovo Space Maintainer","NOT_YET_RECRUITING","2026-05-21",{"date":95,"type":96},"2026-05-29","ACTUAL",{"date":98,"type":80},"2026-06",{"date":100,"type":80},"2027-07",{"name":65,"class":6},1]