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Recruiting NCT05699343

Surgical Treatment of Peri-implantitis Using a Bone Substitute With or Without a Resorbable Collagen Membrane

Conditions: Peri-Implantitis, Surgery

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 52
Sponsor: Andrea Ravida

Location: United States

Summary

The objective of the present randomized clinical trial will be to compare two surgical methods of treating peri-implantitis. This study will determine if surgical debridement of peri-implantitis bone defects, including air decontamination of implant surfaces, in combination with the placement of a bone graft, differs in treatment outcomes compared to placing the same bone graft material with a resorbable collagen membrane placed over the bone graft.

Eligibility Criteria

Inclusion Criteria: To be enrolled, the participant must meet the following inclusion criteria:age 18 years or olderbe patients of record at the University of Pittsburgh Periodontics DepartmentSystemically healthy patientsFull-mouth plaque score and full-mouth bleeding score ≤ 30% (measured at six sites per tooth)Study individuals will be included if they met the following criteria: (a) one or more peri-implant sites with PPD ≥6 mm combined with BOP/suppuration, and (b) peri-implant marginal bone loss, defined as a crater like defect ≥3 mm as assessed from intra- oral radiographs, (c) Infrabony circumferential defect of more than 270° determined by CBCT, (d) crown not possible to retrieve before surgeryExclusion Criteria:study individuals will be excluded if any of the folllowing apply:Unlikely to be able to comply with study procedures and unable to return to SDM for multiple appointments over the course of about a year.Uncontrolled pathologic processes in the oral cavity (cancer and active periodontal disease)History of allergic reactions to dental local anestheticsHistory of head and neck chemotherapy or radiation within 5 years prior to surgerySystemic or local disease or condition that could compromise post-operative healing and/or osseointegration, such as HIV infection, Paget's disease, osteoporosis, etc.Reported diagnosis of diabetes mellitusPatients taking corticosteroids, IV bisphosphonates, or any immunosuppressant medication that could influence post-operative healing and/or osseointegrationSmokes more than 10 cigarettes/day (self-reported)History or current medications with known side effects of gingival growth (including any of the following: phenytoin, phenobarbital, lamotrigine, vigabatrin, ethosuximide, topiramate, primidone, nifedipine, diltazem, amlodipine, felodipine, verapamil, cyclosporine).Present alcohol and/or drug abuser (self-reported)Pregnant, unsure pregnancy status, or lactating females (self-reported), or planning to become pregnant within 1 year of study enrollment

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05699343). StuddyBuddy aggregates publicly available trial information.