Clinical study with gradually anodized implants restored with two‐piece anodized abutments – preliminary results

Abstract

Background: Surface chemistry and topography of the implant-abutment complex play a key role in the implant osseointegration and proper adhesion of the soft tissue to the restoration. To optimize tissue integration at every level, novel anodized implant and abutment surfaces were developed. The implant surface has a gradual change in topography designed to promote early osseointegration and to support stable marginal bone, while the new surface at the tissue-level base promotes undisturbed mucointegration. Aim/Hypothesis: This prospective study aims to evaluate the clinical performance of the gradually anodized implant surface and the smooth anodized abutment surface after 3-year of function. The primary outcome is soft tissue health, thickness and stability evaluated from implant insertion to the 3-year follow-up. Materials and Methods: Patients requiring one single tooth replacement in the premolar or molar area in either jaw were included. Variable thread tapered implants with gradual anodized surface (NobelActive TiUltra, Nobel Biocare AB, Gothenburg, Sweden) were placed in healed sites and an On1 base with anodized surface (On1 Base/Xeal; Nobel Biocare AB) was immediately attached to the implant, and subsequently connected to an On1 healing cap. Digital impressions were taken on the day of surgery, while the final prosthesis was placed after a 12- week healing period. Clinical follow-ups are planned at 6, 12, 24, and 36 months post final prosthetic delivery. The secondary endpoints include soft tissue health assessments, marginal bone levels and remodelling, and oral-health related quality of life based on OHIP-14 questionnaire. Data analysis is performed with SPSS v25 (IBM, Armonk, USA). Results: 60 patients enrolled in the study. As of May 1st, 57 patients (28 females, 29 males; mean age 51.8 ± 12.4 years) received an implant and abutment base each. Most of the implants (64.9%) were placed in hard bone (quality 1 and 2). The mean insertion torque was 58.7 ± 12.3 Ncm (n = 57) and all implants were rated as surviving and stable at both insertion and final prosthesis placement (n = 48). Keratinized mucosa status improved from implant insertion to final prosthesis delivery, with 91.7% of the implants demonstrating the best score at surgery and 100% at final prosthesis delivery (n = 48). Additional analyses including marginal bone levels, plaque accumulation, papilla index, bleeding index, and gingival index, as well as OHIP-14, pain assessment and patient satisfaction, collected until the final prosthetic delivery, will be shown at the time of poster presentation. Conclusions and Clinical Implications: Within the limitations of the short follow-up, 100% implant survival combined with improvement in keratinized mucosa status indicate that the novel anodized surfaces at implants and abutments are safe and promote excellent peri-implant tissue health at every level. Keywords: soft tissue integration, mucointegration, one abutment one time