The efficacy of collagenated xenogenic block bone (A-Oss collagen) in peri-implantitis regenerative surgery compared with particulate xenogenic bone
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0007856
- Lead Sponsor
- Seoul National University Dental Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
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
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Peri-implantitis free survival (PFS) period
- Secondary Outcome Measures
Name Time Method 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)