[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06153212":3,"trial-entities:NCT06153212":99,"trial-summary:NCT06153212":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":45,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":15,"eligibility_criteria":59,"std_ages":79,"locations":82,"central_contacts":92,"overall_officials":93,"references":97,"see_also_links":98},"NCT06153212","HUM00169735","Regenerative Treatment of Peri-implantitis","Regenerative Treatment of Peri-implantitis: A Comparison of the Reinforced PTFE Mesh (RPM) and the Collagen Membrane in the Submerged Approach: a Randomized Controlled Clinical Trial","ENROLLING_BY_INVITATION","2027-12-01","2026-06","2026-07-02","2023-11-02","University of Michigan","OTHER",false,"The purpose of this study is to study the use of a new type of d-PTFE membrane called reinforced PTFE Mesh (RPM) with dental surgery. The regenerative outcomes of RPM membranes and collagen membrane for surgical reconstructive treatment of peri-implantitis (gum disease around implants) will be compared.","Peri-implantitis is an inflammatory response that leads to irreversible loss of implant supporting bone. This study will investigate the regenerative outcomes obtained with two membranes for surgical reconstructive treatment of peri-implantitis defects when the implant is submerged and primary wound closure is obtained. In one group the newly designed d-PTFE membrane with macropores, known as the RPM membrane will be utilized, which will be compared to the traditional collagen membrane used in the other group. The clinical, radiographic, and histologic outcomes for the regenerative treatment of peri-implantitis when utilizing the same bone graft in combination with either a collagen membrane or the RPM will be evaluated via a parallel-arm randomized controlled clinical trial.\n\n32 patients with peri-implantitis will be recruited and randomized to receive peri-implantitis treatment with either a collagen membrane or an RPM membrane.",[19],"Peri-Implantitis",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},32,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"PROCEDURE","Membrane placement with bone grafting","The diseased dental implant will be cleaned and the bone defect will be filled with bone graft and covered by a membrane.",[34,35],"Collagen membrane","PTFE Mesh Membrane",[37,41],{"measure":38,"description":39,"timeFrame":40},"Probing depth measurements in millimeters","To compare probing depth measurements using a periodontal probe after peri-implantitis treatment","About 5 weeks before baseline surgery and at 8.5 months after baseline surgery.",{"measure":42,"description":43,"timeFrame":44},"Bone measurements in millimeters","Bone measurements obtained from CBCT","Baseline and 8 months after baseline surgery",[46,50,53],{"measure":47,"description":48,"timeFrame":49},"Clinical attachment levels in millimeters","To compare clinical attachment measurements using a periodontal probe from baseline to the final follow-up visit","8 months after baseline surgery",{"measure":51,"description":52,"timeFrame":49},"Marginal bone levels in millimeters at the implant site","To compare marginal bone measurements from periapical radiographs",{"measure":54,"description":55,"timeFrame":49},"Volumetric changes of grafted area in cubic millimeters","To compare volumetric bone measurements of the grafted areas from CBCT","ALL","18 Years",null,{"inclusion":60,"exclusion":67,"raw_text":78},[61,62,63,64,65,66],"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.","Subjects having at least one dental implant with peri-implantitis according to the definition proposed by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Berglundh et al., 2018):","Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth)","Correct 3-dimensional implant positioning, or buccal position ≤ 1 mm","Implants which have been in function for at least 6 months",[68,69,70,71,72,73,74,75,76,77],"A clearly mal-positioned dental implant","Significant interproximal horizontal bone loss (more than 50% of implant fixture length)","A mobile dental implant","Presence of uncontrolled or untreated periodontal disease","More than 2 weeks usage of antibiotics in the past two months","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 more than 10 cigarettes a day, or those with a history of drug or alcohol abuse (self-reported)","Subjects unable to maintain adequate oral hygiene (O'Leary plaque index more than 50%) (O'Leary et al., 1972)","Any other contraindications for undergoing periodontal surgery","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* Subjects having at least one dental implant with peri-implantitis according to the definition proposed by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Berglundh et al., 2018):\n* Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth)\n* Correct 3-dimensional implant positioning, or buccal position ≤ 1 mm\n* Implants which have been in function for at least 6 months\n\nExclusion Criteria:\n\n* A clearly mal-positioned dental implant\n* Significant interproximal horizontal bone loss (more than 50% of implant fixture length)\n* A mobile dental implant\n* Presence of uncontrolled or untreated periodontal disease\n* More than 2 weeks usage of antibiotics in the past two months\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 more than 10 cigarettes a day, or those with a history of drug or alcohol abuse (self-reported)\n* Subjects unable to maintain adequate oral hygiene (O'Leary plaque index more than 50%) (O'Leary et al., 1972)\n* Any other contraindications for undergoing periodontal surgery",[80,81],"ADULT","OLDER_ADULT",[83],{"facility":84,"city":85,"state":86,"zip":87,"country":88,"geoPoint":89},"University of Michigan School of Dentistry","Ann Arbor","Michigan","48109","United States",{"lat":90,"lon":91},42.27756,-83.74088,[],[94],{"name":95,"affiliation":13,"role":96},"Muhammad Saleh, BDS, MSD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":100,"biomarkers":102},[101],"Dental peri-implantitis",[],{"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 is a randomized controlled clinical trial involving 32 participants. Participants will be randomly assigned to receive treatment with either a collagen membrane or an RPM membrane.","completed","Regenerative Treatment for Peri-implantitis","This study is looking at a surgical treatment for peri-implantitis (gum disease around dental implants). Researchers want to compare a new type of membrane called reinforced PTFE Mesh (RPM) with a traditional collagen membrane. Both membranes are used with bone grafting to help regrow bone around the implant. The goal is to see which membrane works better at improving probing depth (a measure of gum health) and bone measurements around the implant. You might be able to join if you are at least 18 years old, generally healthy or have well-controlled health conditions, and have at least one dental implant with peri-implantitis. The study's current status is unclear.","Participants will have probing depth measured 8.5 months after surgery and bone measurements taken 8 months after surgery.",108,"The diseased dental implant will be cleaned, and the bone defect will be filled with bone graft and covered by a membrane. Probing depth will be measured about 5 weeks before surgery and 8.5 months after, while bone measurements will be taken at the start and 8 months after surgery.","Not stated in the trial record.",[],"v2"]