Peri-implantitis Oral Health
Conditions
Interventions
Subjects are randomized to either the placebo or active treatment group (choline-stabilized orthosilicic acid) using block randomization in a ratio of 1:1.
All subjects will be instructed to take dail
Sponsors
Bio Minerals NV
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent. 2. Males and Females between the ages of 18 years old and 75 years old. 3. Females must use an approved form of birth control or be postmenopausal or be surgically sterile. 4. Subjects for whom implant placement is required. If tooth extractions are needed, the extraction should be performed at least two months before implant placement. 5. Subjects who are willing to place Nucleoss T6 implants, Medentika and Dentium. 6. Placement needed of single implants with single crown.
Exclusion criteria
Exclusion criteria: 1. Subject is unable to understand the study procedures and/or not having given written informed consent and/or not wishing to participate in one of the subsequent therapeutic intervention protocols. 2. Poor general health interfering with compliance or assessment. 3. Unlikely to co-operate fully in the study. 4. Participating in another clinical trial in the last 90 days. 5. Pregnancy or breastfeeding. 6. Gingival index > 2. 7. Subjects who are not willing to place Nucleoss T6 implant, Medentika or Dentium. 8. Total edentulous subjects. 9. Exclusive placement of implant bridges. 10. Tooth extractions performed less than 2 months before implant placement. 11. Active, untreated periodontitis. 12. Previous bone augmentation procedures. 13. Subjects with documented poorly controlled diabetes (Glycated hemoglobin (HbA1c) level >6%). 14. Subjects with osteoporosis. 15. Osteonecrosis of the jaw. 16. Recent or current alcohol abuse (consumption levels of more than 28 units per week) and drug abuse. 17. Subjects with documented, active infection diseases (included but not limited to HIV, hepatitis B/C). 18. Clinically significant medical abnormalities which would make the subject unsuitable for the study as judged by the investigator. 19. Subjects with current active treatment for renal failure or cancer. 20. Subjects with documented history of stroke or myocardial infarct. 21. Concomitant and previous medication: 21.1 Concomitant and previous treatment with bisphosphonates. 21.2. Concomitant treatment with local antiseptica i.e. rinsing solutions to disinfect the mouth (i.e. Hextril/Hexiditine, Corsodyl). Exception!: chlorhexidine-digluconate rinsing is allowed for treatment until one week after implant placement. 21.23. Concomitant and previous supplementation with food supplements containing horsetail extract, bamboo extract, silicic acid or silanol derivatives within 3 months of the start of the study.
Countries
Türkiye
Contacts
Public ContactStien De Coninck
Outcome results
None listed