[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07556367":3,"trial-entities:NCT07556367":110,"trial-summary:NCT07556367":114},{"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":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":58,"secondary_outcomes":66,"sex":82,"minimum_age":83,"maximum_age":84,"healthy_volunteers":85,"eligibility_criteria":86,"std_ages":90,"locations":93,"central_contacts":103,"overall_officials":104,"references":108,"see_also_links":109},"NCT07556367","242010","Post-Radiation Oral Health in Underserved Head and Neck Cancer Patients","ACTIVE_NOT_RECRUITING","2026-11-30","2026-05","2026-06-01","2024-10-01","University of California, San Francisco","OTHER",true,"This is a pilot study evaluates the feasibility and outcomes of providing fluoride varnish treatment during routine cancer surveillance visits for post-radiation head and neck cancer patients with limited access to dental care.","PRIMARY OBJECTIVES:\n\nI.To describe the baseline knowledge and access to dental care of underinsured\u002Funinsured head and neck cancer patients treated with radiation at University California of San Francisco (UCSF) and Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG).\n\nII.To pilot and characterize the feasibility and outcomes of an in-clinic fluoride varnish dental treatment paired with routine cancer surveillance for post-radiation head and neck cancer patients who do not have reliable access to dental care\n\nIII.To develop readily accessible patient educational material for dental care after radiation treatment for HNC.\n\nSECONDARY OBJECTIVES:\n\nI. Explore barriers and facilitators to adapting an integrated preventative fluoride intervention into clinical care for HNC patients through qualitative interviews.\n\nII. Co-design patient advocacy materials and a clinician implementation toolkit to provide a framework for adopting this intervention diverse community-based settings",[18,19,20],"Head and Neck Cancer","Head and Neck Carcinoma","Head and Neck Neoplasms",[22,23,24,25],"Oral health","Fluoride varnish","Dental care","Radiation therapy","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},43,"ACTUAL",[34,39,44,48,53],{"type":13,"name":35,"description":36,"armGroupLabels":37},"Surveys","Participants will complete surveys to collect information about their dental health before and after fluoride varnish treatment. Healthcare and dental providers will complete a survey to assess the feasibility of the fluoride varnish treatment.",[38],"Fluoride Varnish Treatment (Participant)",{"type":40,"name":41,"description":42,"armGroupLabels":43},"PROCEDURE","Saliva Collection","Participants will provide a saliva sample for pH measurement.",[38],{"type":40,"name":45,"description":46,"armGroupLabels":47},"Intra-oral photographs","Images of participants' teeth will be taken to assess the Decayed, Missing, and Filled Teeth (DMFT) index.",[38],{"type":49,"name":50,"description":51,"armGroupLabels":52},"DEVICE","Fluoride Varnish Treatment","Participants will receive 4-5 fluoride varnish treatment every 3 month over the course of a year. Treatment is delivered during cancer surveillance visits. Participant will also receive dental care educational materials.",[38],{"type":13,"name":54,"description":55,"armGroupLabels":56},"Interview (Participant)","Participants and caregivers will share their experiences accessing dental care, identify barriers to care, and provide their views on integrating preventive dental care into routine medical care. Healthcare and dental providers will share their observations about patient access to dental care and their views on integrating preventive dental care into routine medical care.",[57],"Interview",[59,63],{"measure":60,"description":61,"timeFrame":62},"Mean score of Feasibility of Intervention Measure (FIM)","The Feasibility of Intervention Measure (FIM) is a 4-item implementation measure that assesses participants or providers' perceived feasibility of the intervention. Responses are rated on a 5-point Likert scale ranging from 1 (Completely Disagree) to 5 (Completely Agree). The survey is administered at baseline and at each surveillance visit.","Up to 1 year",{"measure":57,"description":64,"timeFrame":65},"Interview will be conducted with participants and providers using guided questions. Responses will be analyzed to assess the feasibility and potential for expanding the fluoride varnish program.","Up to one day",[67,70,73,76,79],{"measure":68,"description":69,"timeFrame":62},"Mean Change of Score of Dental Care Practice","The Dental Care Practices Survey assesses oral health behaviors and dental care utilization, including frequency of dental visits, toothbrushing tools, and flossing practices. Mean changes in survey scores will be evaluated to assess changes in dental care practices following fluoride varnish treatment and dental health education. Participants will complete the survey at baseline and at each surveillance visit.",{"measure":71,"description":72,"timeFrame":62},"Mean Change of Score of Familiarity with the Risks of Radiation","The Familiarity with the Risks of Radiation Survey assesses knowledge of the effects of head and neck radiation on oral health and attitudes toward seeking dental care. Mean changes in survey scores will be evaluated to assess changes in knowledge and attitudes following fluoride varnish treatment and dental health education. Participants will complete the survey at baseline and at each surveillance visit.",{"measure":74,"description":75,"timeFrame":62},"Change in Saliva potential hydrogen (pH) measure","Changes in salivary potential hydrogen (pH) will be evaluated to assess changes in oral health status following fluoride varnish treatment and dental health education. Saliva samples will be collected from participants at baseline and at each surveillance visit, and pH will be measured using a digital pH meter.",{"measure":77,"description":78,"timeFrame":62},"Mean Change of Score of Oral Health-Related Quality of Life (OHRQoL)","Participants will complete the Oral Health Impact Profile-14 (OHIP-14) to assess oral health-related quality of life (OHRQoL). The OHIP-14 is a 14-item questionnaire that measures OHRQoL across seven domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Responses are rated on a 5-point Likert scale ranging from 0 (Never) to 5 (Always). Mean changes in OHRQoL scores will be used to evaluate changes following fluoride varnish treatment and dental health education. The questionnaire will be completed at baseline and at each surveillance visit.",{"measure":80,"description":81,"timeFrame":62},"Mean score Change in Decayed-Missing-Filled Teeth (DMFT) Index","The Decayed, Missing, and Filled Teeth (DMFT) index is measured as the number of decayed, missing, and filled teeth. Mean changes in DMFT scores will be used to evaluate changes in oral health following fluoride varnish treatment and dental health education. The DMFT assessment will be performed at baseline and at each surveillance visit.","ALL","18 Years",null,false,{"inclusion":87,"exclusion":88,"raw_text":89},[],[],"Inclusion Criteria:\n\n1. \\>18 years old who are uninsured or underinsured (MediCal, Healthy SF) or have full coverage.\n2. Patients who have received immunotherapy or enhanced chemotherapy regimens.\n3. Patients or health and dental care providers who are able to provide their own informed written consent.\n\nExclusion Criteria:\n\n1. \\>18 years old.\n2. Patients, caregivers, health and dental care providers who are able to provide their own informed written consent.",[91,92],"ADULT","OLDER_ADULT",[94],{"facility":95,"city":96,"state":97,"zip":98,"country":99,"geoPoint":100},"Zuckerberg San Francisco General Hospital (ZSFG)","San Francisco","California","94110","United States",{"lat":101,"lon":102},37.77493,-122.41942,[],[105],{"name":106,"affiliation":12,"role":107},"Mary J Xu, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":111,"biomarkers":113},[112],"Malignant Head and Neck Neoplasm",[],{"nct_id":4,"found":14,"summary":115,"prompt_version":125},{"design":116,"status":117,"heading":118,"summary":119,"follow_up":120,"word_count":121,"commitments":122,"compensation":123,"drugs_mentioned":124},"This is an interventional pilot study with a planned enrollment of 43 participants. It is not specified if it is randomized or blinded.","completed","Oral Health Study for Head and Neck Cancer Patients After Radiation","This study is looking at how well fluoride varnish treatment works to improve oral health for head and neck cancer patients who have had radiation and have limited access to dental care. It's a pilot study, meaning it's a small-scale test to see if this approach is practical. You might be eligible if you are over 18, have head and neck cancer, have received immunotherapy or enhanced chemotherapy, and have certain insurance types (uninsured, underinsured, or full coverage). The study will look at how easy it is to provide fluoride varnish during regular cancer check-ups and how it affects your dental health. Researchers will also gather information about your experiences with dental care and any challenges you face.","The feasibility of the intervention will be measured for up to one year. Interviews will be conducted for up to one day.",118,"You would complete surveys, provide saliva samples, have intra-oral photographs taken, and receive fluoride varnish treatment every 3 months for a year. You and your caregivers would also participate in interviews.","Not stated in the trial record.",[50],"v2"]