[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550918":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":55,"collaborators":18,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":18,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":18,"enrollmentInfo":68,"targetDuration":18,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":18,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"University of Dublin, Trinity College","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"An intervention group receiving standard placement of single implants with H-PRF","EXPERIMENTAL","H-PRF preparation protocol involves taking a sample of venous blood from patients using a butterfly needle to collect up to 8-9ml tubes of blood. After the first tube is collected, it would immediately be placed in a horizontal centrifuge machine, balanced out with 3 tubes of water, to ensure the centrifuge is properly balanced. A set rpm and time will be chosen, and the centrifuge will run until the time is complete. The H-PRF clots would then be ready and taken out of the tubes to separate them from the red blood cells.",[13],"Biological: Horizontal platelet-rich fibrin (H-PRF)",{"label":15,"type":16,"description":17,"interventionNames":18},"A control group receiving standard placement of single implants without H-PRF","NO_INTERVENTION","this group will have standard implant placement without H-PRF",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BIOLOGICAL","Horizontal platelet-rich fibrin (H-PRF)","Most commercially available centrifuges used for PRF production are fixed-angle systems designed primarily for pelleting samples to the bottom of tubes and are not particularly efficient at separating the cell layers effectively. Research has demonstrated that PRF produced using horizontal centrifugation (H-PRF) can lead to a higher concentration of platelets and leukocytes compared to PRF produced from fixed-angle centrifugation (LPRF). The resulting PRF from horizontal centrifugation is termed 'horizontal platelet-rich fibrin' (H-PRF). The H-PRF clot will be produced using a Bio-PRF horizontal centrifuge machine. This machine is CE marked and regularly used in the Dublin Dental University Hospital.",[9],[26],{"name":27,"affiliation":28,"role":29},"Dr Ioannis Polyzois, Consultant","Dublin Dental University Hospital","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Rawan Kahatab, BDS","CONTACT","00353871679359","kahatabr@tcd.ie",{"name":27,"role":33,"phone":37,"phoneExt":18,"email":38},"01 6127391","ioannis.polyzois@dental.tcd.ie",[40],{"facility":28,"status":41,"city":42,"state":18,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Dublin","D02 F859","Ireland","IE",{"type":47,"coordinates":48},"Point",[49,50],-6.24889,53.33306,{"lat":50,"lon":49},[53],{"name":32,"role":33,"phone":54,"phoneExt":18,"email":35},"00353 871679359",{"type":29,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Rawan Kahatab","Postgraduate periodontology student","100550918","a-randomised-control-clinical-trial-investigating-the-effect-of-h-prf-on-implant-stability-and-marginal-bone-levels-100550918",false,"NCT06453330","A Randomised Control Clinical Trial Investigating the Effect of H-PRF on Implant Stability and Marginal Bone Levels","A Randomised Control Clinical Trial Investigating the Effect of Horizontal-Platelet-Rich Fibrin (H-PRF) vs Standard Placement on Implant Stability and Marginal Bone Levels in Adults","Inclusion Criteria:\n\nPatient Level\n\n* Male or Female, 18 years old or over\n* Capacity to provide informed consent\n* Willing to comply with study appointment schedule and willing to maintain a diary of symptoms\n* Planned for provision of dental implant(s) at Dublin Dental University Hospital Site Level\n* Sufficient bone volume for implant placement without the need for bone graft\u002Faugmentation; alveolar ridge of minimum 6mm width for standard implants (implant diameter 4mm) and of minimum 7mm for wider implants (implant diameter 5mm)\n\nExclusion Criteria:\n\nPatient Level\n\n* Plaque score \\>20%\n* Bleeding score \\>20%\n* Tobacco smoking\n* Uncontrolled systemic disease\n* Use of systemic medications with an expected impact on bone healing (e.g. bisphosphonates)\n* Pregnancy or lactation\n* Lack capacity to give informed consent\n* History of radiotherapy to the head and\u002For neck Site Level\n* Insufficient bone volume for implant placement, requiring bone graft\u002Faugmentation",true,"ALL","18 Years",{"count":69,"type":70},50,"ESTIMATED","INTERVENTIONAL",[73],"NA","This research will be a randomised controlled trial (RCT) investigating whether the use of Horizontal Platelet Rich Fibrin (H-PRF) increases implant stability compared to those implants placed without H-PRF, and therefore, contributes to the implant's overall success.\n\nH-PRF is a second generation platelet concentrate that consists of a fibrin mesh containing cytokines and leukocytes. It has been shown to stimulate mesenchymal stem cells and osteoblasts that encourage bone formation as a result of the growth factors released from platelets, which should aid in osseointegration of implants. There is limited research that investigates the effects of H-PRF on implant stability. There is, however, some evidence that platelet-rich fibrin (PRF), which is produced in a fixed-angle centrifuge, increases implant stability and H-PRF is considered the evolution of PRF products.\n\nThis research would follow a H-PRF preparation protocol which involves taking a sample of venous blood from patients using a butterfly needle to collect up to 8-9ml tubes of blood. After the tube of blood is collected, it would immediately be placed in a horizontal centrifuge machine with 3 tubes of water to balance the centrifuge, and placed opposite each other. A set rpm and time will be chosen, and the centrifuge will run until the time is complete. The H-PRF clots would then be ready and taken out of the tubes to separate them from the red blood cells.\n\nFollowing randomisation, implants will be placed in the upper or lower jaws of patients attending the Dublin Dental University Hospital using the standard implant protocol. Half of the implants will be coated with H-PRF, the other half (control group) would be placed without HPRF. Implant stability and marginal bone levels will be measured at three different stages: 1) Initial implant placement, 2) Second stage surgery when the implant is uncovered after healing and integrated with the bone, 3) When the definitive crown or bridge is attached to the implant. Insertion torque at baseline will also be measured. The above results will be collected and assessed to determine the effects of H-PRF, if any, on implant stability and the preservation of bone levels around implants.",[76],"Osseointegration Failure of Dental Implant","2024-06-10",{"date":79,"type":80},"2024-06-11","ACTUAL",{"date":82,"type":80},"2024-05-17",{"date":84,"type":70},"2026-09-01",{"name":5,"class":6},1]