[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06185075":3,"trial-entities:NCT06185075":79,"trial-summary:NCT06185075":83},{"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":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":35,"secondary_outcomes":48,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":52,"eligibility_criteria":53,"std_ages":59,"locations":62,"central_contacts":72,"overall_officials":73,"references":77,"see_also_links":78},"NCT06185075","HUM00208140 Substudy","Influence of Implant Crown Transmucosal Contour Design on Soft and Hard Tissue Clinical Outcomes","ENROLLING_BY_INVITATION","2026-12-01","2026-02","2026-02-12","2023-11-28","University of Michigan","OTHER",false,"This study will evaluate how the crown's shape under the gums will influence the gum tissue around dental implants.","This research is studying the transmucosal contour, or shape of crowns (white-colored tooth structure that sits above the gum) under the gums on dental implants. Participants will be randomly selected for the dental implant crown to be designed with either a straight or concave transmucosal contour, and followed up on for 1 year after crown delivery.",[18],"Gum Disease",[],"INTERVENTIONAL","TREATMENT",[23],"NA",{"count":25,"type":26},30,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"PROCEDURE","Implant crown delivery","Dental implant crown will be designed, fabricated by a dental lab, and delivered.",[33,34],"Concave transmucosal contour","Straight transmucosal contour",[36,40,43,45],{"measure":37,"description":38,"timeFrame":39},"Marginal bone loss around dental implant","Measured from radiographs in mm","6 months and 12 months after crown delivery",{"measure":41,"description":42,"timeFrame":39},"Gum tissue thickness","Measured from intraoral scan in mm",{"measure":44,"description":42,"timeFrame":39},"Gingival margin height",{"measure":46,"description":47,"timeFrame":39},"Amount of keratinized gingiva","Measured clinically in mm",[],"ALL","20 Years","80 Years",true,{"inclusion":54,"exclusion":57,"raw_text":58},[55,56],"Be a current participant of HUM00208140 main study","Have a dental implant that is ready to be restored (placed at least 3 months ago and healing is adequate)",[],"Inclusion criteria\n\n* Be a current participant of HUM00208140 main study\n* Have a dental implant that is ready to be restored (placed at least 3 months ago and healing is adequate)\n\nExclusion Criteria:\n\n• The dental implant crown was already delivered.",[60,61],"ADULT","OLDER_ADULT",[63],{"facility":64,"city":65,"state":66,"zip":67,"country":68,"geoPoint":69},"University of Michigan School of Dentistry","Ann Arbor","Michigan","48109","United States",{"lat":70,"lon":71},42.27756,-83.74088,[],[74],{"name":75,"affiliation":12,"role":76},"Muhammad Saleh, BDS, MSD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":80,"biomarkers":82},[81],"Gingival Disorder",[],{"nct_id":4,"found":52,"summary":84,"prompt_version":94},{"design":85,"status":86,"heading":87,"summary":88,"follow_up":89,"word_count":90,"commitments":91,"compensation":92,"drugs_mentioned":93},"This is an interventional study where participants are randomly assigned to receive one of two dental implant crown designs. It plans to enroll 30 participants.","completed","Dental Implant Crown Design Study","This study is looking at how the shape of a dental implant crown (the white tooth part above the gum) under your gums affects the gum tissue around your dental implants. You would receive an implant crown designed with either a straight or concave shape under the gums. Researchers will measure changes in bone loss around the implant, gum thickness, and gum height to see which design works best. To join, you need to be between 20 and 80 years old, already be part of the HUM00208140 main study, and have a dental implant that's ready for a crown. The study aims to enroll 30 participants, but its current status is unclear.","Participants will be followed for 12 months after crown delivery.",112,"You would receive a dental implant crown and be followed up for one year after the crown is delivered.","Not stated in the trial record.",[],"v2"]