None listed
Conditions
Interventions
Medical Device : The intervention groups consist of a test group applying a collagenated block type bone substitute (A-Oss Collagen) to the peri-implant defect and an active control group applying a p
Sponsors
Seoul National University Dental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects whose general condition is eligible for surgical treatment of peri-implantitis. 2. Subjects who have undergone nonsurgical treatment of peri-implantitis within the last 3 months, but the lesion has not been resolved. 3. Implant prosthesis can be removed. 4. Subjects with intrabony defects around implants on radiographs. 5. peri-implant bone loss on radiograph: 6 mm or less on radiographs. 6. Subjects who voluntarily consent to the clinical trial and are willing to comply with the protocol
Exclusion criteria
Exclusion criteria: 1. Acute infection at the site where peri-implantitis is present. 2. Extensive bone loss due to peri-implantitis and/or periodontitis that requires extraction of adjacent teeth. 3. Pregnant or lactating women. 4. Uncontrolled metabolic systemic disease (hypertension, diabetes). 5. A history of radiation therapy and chemotherapy in the head and neck area. 6. Complications of serious cardiovascular disease, respiratory system disease, kidney disease, liver disease, digestive system disease, blood system disease, and neuropsychiatric disease. 7. A history of severe drug allergy. 8. Subjects receiving long-term systemic steroid therapy. 9. Subjects with ASA classification III, IV, V, VI. 10. Surgical treatment was not recommended by a physician due to the risk of medication-related osteonecrosis of the jaw (MRONJ). 11. Subject is inappropriate for participating in the research due to ethical issues.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peri-implantitis free survival (PFS) period | — |
Secondary
| Measure | Time frame |
|---|---|
| surgical treatment time;patient reported outcome measures;peri-implantitis treatment success (Heitz-Mayfield LJ. et al. 2018);peri-implantitis progression free survival (PPFS) period;overall survival (OS) period;peri-implant probing depth;peri-implant mucosa recession;width of keratinized mucosa ;vestibule depth;modified plaque index;modified bleeding index;full mouth plaque score;bleeding on probing(BOP) | — |
Countries
Korea, Republic of
Contacts
Public ContactHyunYoung Song
Seoul National University Dental Hospital
Outcome results
None listed