Generalized dental plaque-induced gingivitis Oral Health
Conditions
Interventions
Participants are randomized to either the placebo or active treatment group (choline-stabilized orthosilicic acid [CS-OSA]) using block randomization in a ratio of 1:1.
All participants will be instr
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. Healthy, non-institutionalized males and females between the ages of 18 and 75 years old 3. Females must use an approved form of birth control or be postmenopausal or surgically sterile 4. A minimum of 3 natural teeth in every quadrant 5. Patients with generalized gingivitis, characterized by a BOP =30%
Exclusion criteria
Exclusion criteria: 1. Patient 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. Smoking or history of smoking (less than 6 months prior to the start of the study) 7. Patients with poorly controlled diabetes 8. Osteonecrosis of the jaw 9. Spontaneous bleeding of the gums 10. Documented history of periodontitis 11. Patient has more than 5 crowns 12. Recent or current alcohol abuse (consumption levels of more than 28 units per week) and drug abuse 13. Subjects with documented, active infectious diseases (including but not limited to HIV, hepatitis B/C) 14. Clinically significant medical abnormalities which would make the subject unsuitable for the study as judged by the investigator 15. Patient has renal failure, documented history of stroke, myocardial infarction, or cancer 16. Non-plaque induced gingival diseases: 16.1. Hereditary gingival fibromatosis 16.2. Infection of bacterial, viral or fungal origin resulting in non-plaque-induced gingival lesions 16.3. Inflammatory and auto-immune conditions such as Crohn’s disease, plasma cell gingivitis, etc 16.4. Vitamin C deficiency 16.5. Traumatic lesions such as toothbrushing-induced gingival ulceration or chemical injuries 17. Concomitant and previous medication: 17.1. Concomitant and previous treatment with systemic antibiotics within 3 months of the start of the study 17.2. Concomitant treatment with local antiseptic, i.e. rinsing solutions to disinfect the mouth (i.e. Hextril/Hexiditine, Corsodyl/chlorhexidine-digluconate) 17.3. 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 17.4. Less than 3 months between the extraction of teeth and the start of the study 17.5. No other periodontal treatment is allowed during the course of the study
Countries
Portugal, Slovenia, Türkiye
Contacts
Public ContactMattias Bonnarens
Outcome results
None listed