A randomized controlled trial (RCT) conducted at two centers investigating the soft tissue reactions in patients following implantation of a novel bone-level implant with a trioval-conical abutment connection and mesostructure. The study compares this with conventional tissue-level implants, focusing on clinical parameters of peri-implant soft tissue health and aesthetics.
Conditions
Interventions
Group 1: In 40 patients requiring the insertion of at least two implants, two implants will be placed in each patient according to the manufacturer’s instructions, with adherence to the specified heal
Sponsors
Charité – Universitätsmedizin Berlin Zahnärztliche Prothetik, Alterszahnmedizin und Funktionslehre
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: No contraindications for implants. Above-average oral hygiene (API < 20%). Fully dentate / fixed prosthetic restoration with the need for 2 posterior tooth implants. Sufficient bone volume / history of augmentation to accommodate implants with at least 4 mm diameter and 9 mm length.
Exclusion criteria
Exclusion criteria: Contraindications for oral surgical procedures/implants. Active periodontal disease (PPD > 5 mm). Known pregnancy. Alcohol or drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bacterial load (reads) of the sulcular peri-implant soft tissue (taxonomic classification of bacteria) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. number of inflammatory cells, collagen and fibroblasts in the histological preparation of the peri-implant soft tissue 2. clinical survival rate of the implants used 3. clinical survival rate of the inserted crowns 4. marginal bone level 5. decrease of the peri-implant (Pink esthetic score) 6. patient assessment (PROMs: pain; chairside treatment time; comfort/homeliness) 7. bacterial diversity of the peri-implant sulcus 8. papilla index (Jemt) 9. white esthetic score (WES) 10. volume of the soft tissue by intraoral scan 11. plaque index (PPI) 12. bleeding on probing (BOP) 13 Modified Gingiva Index (MGI) 14. pocket depths (PPD) 15. attachment loss 16. width of keratinized mucosa (KM) 17. peri-implant tissue score (PITS) 18. matrix metalloproteinase 8 (sulcus fluid) 19. histological parameters (health status) 20. immunohistologic analyses (biopsy) 21. questionnaire (OHIP G14 + VAS) 22. prosthetic result (AEs including chipping) | — |
Countries
Germany
Contacts
Public ContactFlorian Beuer
Charité – Universitätsmedizin Berlin Zahnärztliche Prothetik, Alterszahnmedizin und Funktionslehre
Outcome results
None listed