[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07535008":3,"trial-entities:NCT07535008":98,"trial-summary:NCT07535008":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":40,"secondary_outcomes":44,"sex":53,"minimum_age":54,"maximum_age":55,"healthy_volunteers":14,"eligibility_criteria":56,"std_ages":71,"locations":74,"central_contacts":92,"overall_officials":94,"references":96,"see_also_links":97},"NCT07535008","RG1126351","Dental Cleaning to Prevent Chronic Graft-Versus-Host Disease","RECRUITING","2029-04-30","2026-04","2026-08-12","2026-06-11","Fred Hutchinson Cancer Center","OTHER",false,"This clinical trial evaluates the feasibility and effectiveness of a post-transplant dental cleaning for the prevention of chronic graft versus host disease (GVHD) in patients undergoing an allogeneic hematopoietic cell transplant (HCT). HCT is the only curative treatment for some types of blood cancer. Unfortunately, this approach can lead to the development of GVHD, which is a disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Some research has shown that the bacteria that is present in the dental plaque soon after transplant may affect the development of chronic GVHD. Dental cleanings prior to transplant are part of the normal standard of care for patients undergoing HCT. Adding an additional cleaning shortly after HCT may be effective for preventing the development of chronic GVHD.","OUTLINE:\n\nPatients who have not undergone dental cleaning within 3 months preceding the baseline visit undergo dental cleaning at baseline (before the initiation of transplant conditioning) according to standard of care. All patients undergo simplified dental cleaning on day +28 following HCT.\n\nAfter completion of study intervention, patients are followed up on days +84 and +180 and at 1 year.",[18,19,20],"Chronic Graft Versus Host Disease","Acute Graft Versus Host Disease","Hematopoietic and Lymphatic System Neoplasm",[],"INTERVENTIONAL","PREVENTION",[25],"NA",{"count":27,"type":28},45,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"PROCEDURE","Dental Cleaning","Dental cleaning",[35],"Prevention (dental cleaning)",{"type":31,"name":37,"description":38,"armGroupLabels":39},"Dental Plaque sampling","Ancillary studies",[35],[41],{"measure":42,"timeFrame":43},"Probability of moderate-to-severe chronic graft versus host disease","At 1-year post-transplant",[45,48,51],{"measure":46,"timeFrame":47},"Probability of grade III-IV acute graft versus host disease","At 6-months post-transplant",{"measure":49,"timeFrame":50},"Proportion of eligible patients approached who consent (feasibility)","Up to 2 years",{"measure":52,"timeFrame":50},"Proportion of enrolled patients who receive the intervention (feasibility)","ALL","18 Years",null,{"inclusion":57,"exclusion":65,"raw_text":70},[58,59,60,61,62,63,64],"Age ≥ 18 years old","T-replete allogeneic hematopoietic cell transplantation for any indication. History of prior transplantation is allowed. Any conditioning regimen is allowed","One of the following HCT donor types:","9\u002F10 or 10\u002F10 human leukocyte antigen (HLA)-matched unrelated donor","Cord blood","Willing to have an in-person 1-year long-term follow-up (LTFU) visit including an oral medicine at Fred Hutch (FH)","Ability to understand and sign a written informed consent document (or legal representative)",[66,67,68,69],"Edentulous state","Bone marrow as graft source","Use of post-transplantation cyclophosphamide (PTCy) or ruxolitinib as GVHD prophylaxis","Use of anti-thymocyte globulin (ATG) in conditioning","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* T-replete allogeneic hematopoietic cell transplantation for any indication. History of prior transplantation is allowed. Any conditioning regimen is allowed\n* One of the following HCT donor types:\n\n  * 9\u002F10 or 10\u002F10 human leukocyte antigen (HLA)-matched unrelated donor\n  * Cord blood\n* Willing to have an in-person 1-year long-term follow-up (LTFU) visit including an oral medicine at Fred Hutch (FH)\n* Ability to understand and sign a written informed consent document (or legal representative)\n\nExclusion Criteria:\n\n* Edentulous state\n* Bone marrow as graft source\n* Use of post-transplantation cyclophosphamide (PTCy) or ruxolitinib as GVHD prophylaxis\n* Use of anti-thymocyte globulin (ATG) in conditioning",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":76,"status":7,"city":77,"state":78,"zip":79,"country":80,"contacts":81,"geoPoint":89},"Fred Hutch\u002FUniversity of Washington Cancer Consortium","Seattle","Washington","98109","United States",[82,87],{"name":83,"role":84,"phone":85,"email":86},"Armin Rashidi, MD, PhD","CONTACT","206-667-2506","arashidi@fredhutch.org",{"name":83,"role":88},"PRINCIPAL_INVESTIGATOR",{"lat":90,"lon":91},47.60621,-122.33207,[93],{"name":83,"role":84,"phone":85,"email":86},[95],{"name":83,"affiliation":76,"role":88},[],[],{"nct_id":4,"conditions":99,"biomarkers":100},[20],[],{"nct_id":4,"found":102,"summary":103,"prompt_version":112},true,{"design":104,"status":105,"heading":6,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is an interventional study planning to enroll 45 participants. It involves a dental cleaning procedure after a stem cell transplant.","completed","This study is looking at whether dental cleanings can help prevent chronic graft-versus-host disease (GVHD) in people who have had a stem cell transplant (HCT). HCT is a treatment for some blood cancers, but it can sometimes lead to GVHD, where the new cells attack your body. Some research suggests that bacteria in your mouth might play a role in developing chronic GVHD. This trial will provide a dental cleaning around 28 days after your transplant. Researchers will then see if this helps reduce the chance of developing moderate-to-severe chronic GVHD one year after your transplant. You might be able to join if you are 18 or older, have had a specific type of HCT, and are willing to have a follow-up visit one year later. The current status of this study is unclear, and it plans to enroll 45 participants.","Participants are followed up on days +84 and +180, and at 1 year after the intervention.",141,"You would receive a simplified dental cleaning around 28 days after your transplant. You will then have follow-up visits on days +84, +180, and at 1 year.","Not stated in the trial record.",[32],"v2"]