[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07732647":3,"trial-entities:NCT07732647":99,"trial-summary:NCT07732647":103},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":36,"secondary_outcomes":44,"sex":57,"minimum_age":58,"maximum_age":15,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":78,"locations":81,"central_contacts":91,"overall_officials":92,"references":97,"see_also_links":98},"NCT07732647","HUM00275903","Immediate Implant Provisionalization","Soft Tissue Stability of Immediate Implant Placement With and Without Immediate Provisionalization: A Randomized Controlled Clinical Trial","ENROLLING_BY_INVITATION","2028-08-31","2026-07","2026-07-29","2026-08-01","University of Michigan","OTHER",null,"This research is studying gum tissue stability of dental implants placed at same appointment as the tooth extraction, with or without a provisional (temporary) crown.","This study aims to find out whether a new type of hybrid dental implant-which has a smooth surface near the gums to make cleaning easier and potentially lower the risk of infection-can help improve gum health and reduce implant complications. It also compares two common treatment approaches after tooth removal: placing a temporary provisional crown immediately versus using a standard healing cap. By studying these options, we hope to learn which method provides better healing, protects the gums more effectively, and leads to fewer problems around the implant.",[19],"Gum Disease",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},44,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","Dental implant placement","A dental implant will be placed after tooth extraction.",[34,35],"Healing cap","Provisional crown",[37,41],{"measure":38,"description":39,"timeFrame":40},"Linear changes of gum tissue architecture","Digitally measured soft tissue changes in mm\\^2 using intraoral and CBCT scans","1 month and 4 months after baseline surgery, 6 months and 12 months after crown delivery",{"measure":42,"description":43,"timeFrame":40},"Volumetric changes of gum tissue architecture","Digitally measured soft tissue changes in mm\\^3 using intraoral and CBCT scans",[45,49,53],{"measure":46,"description":47,"timeFrame":48},"Changes in marginal bone","Digitally measured marginal bone changes from radiographs in mm","5 months after baseline surgery, 6 months and 12 months after crown delivery",{"measure":50,"description":51,"timeFrame":52},"Patient-reported satisfaction","Percentage of pain reported via post-operative diary","14 days after baseline surgery",{"measure":54,"description":55,"timeFrame":56},"Microbial profile","Amount of microbes and immune cells measured as means and medians with standard deviations.","Baseline, 4 months after baseline surgery, 6 months and 12 months after crown delivery","ALL","18 Years",false,{"inclusion":61,"exclusion":68,"raw_text":77},[62,63,64,65,66,67],"Age ≥ 18 years","Physical status according to the American Society of Anesthesiology (ASA) I or II, which include patients who are systematically healthy or may suffer from mild to moderate, however well-controlled systemic diseases.","Periodontally healthy or with treated periodontitis with good oral hygiene ((FMPS) and (FMBS) ≤15%, measured at four sites per tooth).","Presence of one non-restorable maxillary anterior tooth (from #5 to #12 sites)","More than 20 occluding teeth with stable occlusion.","Nonsmokers or smokers \\\u003C 10 cig\u002Fday (self-reported).",[69,70,71,72,73,74,75,76],"Presence of uncontrolled or untreated periodontal disease.","Presence of active periapical infection.","Subjects taking medications known to modify bone metabolism or those that can interfere with the normal wound healing (such as bisphosphonates, corticosteroids, hormone replacement therapy, parathyroid hormone, denosumab, strontium ranelate, etc.), or those with uncontrolled systemic diseases or conditions that may similarly affect the patient's healing (osteoporosis, osteopenia, hyperparathyroidism, Paget's disease, uncontrolled diabetes (HBA1c \\> 8)).","Pregnant subjects or individuals attempting to get pregnant (self-reported)","Subjects smoking 10 or more cigarettes a day, or those with a history of drug or alcohol abuse (self-reported)","Subjects unable to maintain adequate oral hygiene","Insufficient restorative space or bite collapse.","Lack of primary implant stability assessed intrasurgically.","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Physical status according to the American Society of Anesthesiology (ASA) I or II, which include patients who are systematically healthy or may suffer from mild to moderate, however well-controlled systemic diseases.\n* Periodontally healthy or with treated periodontitis with good oral hygiene ((FMPS) and (FMBS) ≤15%, measured at four sites per tooth).\n* Presence of one non-restorable maxillary anterior tooth (from #5 to #12 sites)\n* More than 20 occluding teeth with stable occlusion.\n* Nonsmokers or smokers \\\u003C 10 cig\u002Fday (self-reported).\n\nExclusion Criteria:\n\n* Presence of uncontrolled or untreated periodontal disease.\n* Presence of active periapical infection.\n* Subjects taking medications known to modify bone metabolism or those that can interfere with the normal wound healing (such as bisphosphonates, corticosteroids, hormone replacement therapy, parathyroid hormone, denosumab, strontium ranelate, etc.), or those with uncontrolled systemic diseases or conditions that may similarly affect the patient's healing (osteoporosis, osteopenia, hyperparathyroidism, Paget's disease, uncontrolled diabetes (HBA1c \\> 8)).\n* Pregnant subjects or individuals attempting to get pregnant (self-reported)\n* Subjects smoking 10 or more cigarettes a day, or those with a history of drug or alcohol abuse (self-reported)\n* Subjects unable to maintain adequate oral hygiene\n* Insufficient restorative space or bite collapse.\n* Lack of primary implant stability assessed intrasurgically.",[79,80],"ADULT","OLDER_ADULT",[82],{"facility":83,"city":84,"state":85,"zip":86,"country":87,"geoPoint":88},"University of Michigan School of Dentistry","Ann Arbor","Michigan","48109","United States",{"lat":89,"lon":90},42.27756,-83.74088,[],[93],{"name":94,"affiliation":95,"role":96},"Hom-Lay Wang, DDS MSD PhD","Department of Periodontics and Oral Medicine, University of Michigan","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":100,"biomarkers":102},[101],"Periodontitis",[],{"nct_id":4,"found":104,"summary":105,"prompt_version":115},true,{"design":106,"status":107,"heading":108,"summary":109,"follow_up":110,"word_count":111,"commitments":112,"compensation":113,"drugs_mentioned":114},"This interventional study plans to enroll 44 participants. It compares two different approaches for dental implant placement.","completed","Immediate Implant Provisionalization for Gum Disease","This study is looking at how well dental implants work when placed right after a tooth is pulled, especially for people with gum disease. Researchers are comparing two ways to treat the area after tooth removal: either placing a temporary crown right away or using a standard healing cap. The study also uses a special type of dental implant that has a smooth surface near the gums, which might make it easier to clean and reduce infection risk. We want to see which method leads to better gum healing and fewer problems around the implant. You can join if you are at least 18 years old, generally healthy, and have good oral hygiene or treated gum disease. The study is currently unclear about its recruitment status.","Participants will be followed for 12 months after crown delivery to measure changes in gum tissue.",126,"A dental implant will be placed after tooth extraction. Your gum tissue will be measured at 1 month, 4 months, 6 months, and 12 months after surgery and crown delivery.","Not stated in the trial record.",[],"v2"]