Peri-implantitis Oral Health Peri-implantitis, dental implant
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 instru
Sponsors
Bio Minerals NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Peri-implantitis, defined as bone loss of more than 3 mm measured on intra-oral radiographs and a probing pocket depth (PPD) of more than 4 mm with bleeding on probing (BOP) or pus on probing 2. Patients with single and multiple osseointegrated implants 3. Aged between 18 and 75 years 4. Use of an approved form of birth control if at risk of pregnancy 5. Provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Unable to understand the study procedures 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. Smoking or history of smoking (=6 months prior to the start of the study) 7. Gingival index >2 8. Active, untreated periodontitis 9. Mobile implants (i.e. complete disintegration/loss of contact of the implant with the bone) 10. Patients with poorly controlled diabetes 11. Osteonecrosis of the jaw 12. Recent or current alcohol abuse and drug abuse 13. High-risk group for HIV 14. Clinically significant medical abnormalities which would make the subject unsuitable for the study as judged by the investigator 15. Renal failure, documented history of stroke, myocardial infarct, or cancer 16. Concomitant and previous medication 16.1. Less than 6 months between the treatment with systemic antibiotics and the start of the study 16.2. Concomitant and previous treatment with bisphosphonates 16.3. Concomitant treatment with local antiseptica i.e. rinsing solutions to disinfect the mouth (i.e. Hextril/Hexetidine, Corsodyl/chlorhexidine-digluconate) 16.4. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The probing pocket depth (PPD) is measured using a calibrated probe at 6 peri-implantitis sites at baseline and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The probing pocket depth (PPD) is measured using a calibrated probe at 6 peri-implantitis sites at baseline and 6 months 2. Bleeding on probing (BOP) is measured using a calibrated probe at 6 peri-implantitis sites at baseline, 6 and 12 months 3. Gingival recession (REC) is measured using a calibrated probe at 6 peri-implantitis sites at baseline, 6 and 12 months 4. Bone gain is measured with cone-beam computed tomography (CBCT) at baseline, 6 and 12 months 5. Biomarkers of bone formation and bone resorption are measured from samples taken at baseline, 6 and 12 months 6. Serum markers of inflammation (hs-CRP) are measured from serum samples taken at baseline, 6 and 12 months 7. Patient assessment of the impact of oral health measured using the Oral Health Impact Profile (OHIP)-14 questionnaire at baseline, 6 and 12 months | — |
Countries
Turkey
Contacts
Public ContactSara Persyn
Outcome results
None listed