Evaluation of the clinical safety and performance of a narrow diameter (2.9 mm) bone-level implant: a 1-year prospective single-arm multicenter study

Abstract

Purpose Narrow-diameter implants facilitate single‐tooth restoration when interdental or inter-implant spaces and bone volume are inadequate for using standard diameter implants. This study reports the short-term data on the clinical safety and performance of a bone-level-tapered two-piece implant with a 2.9 mm diameter in the clinical practice setting. This study was retrospectively registered on March 1st, 2016 (NCT02699866). Methods Implants were placed in partially healed extraction sockets of the central and lateral incisors in the mandible and lateral incisors in the maxilla for single-tooth replacement. The primary outcome was to assess implant survival at 12 months after placement. Secondary outcomes included implant success, pink esthetic score, marginal bone-level changes, and safety. Results Twenty four males and 17 females with a mean age of 44.5 (± 18.3 standard deviation) received the implant. Three out of 41 implants were lost yielding a survival rate of 92.7% (95%-CI: 79.0%; 97.6%) at 1 year. One patient reported an ongoing foreign body sensation, pain, and/or dysesthesia at month 12. The average pink esthetic score at 6 months was 11.2 (95%-CI: 10.5; 11.9). The bone level was stable with a mean bone-level change of—0.3 mm (± 0.42 mm standard deviation) at 1 year after implantation. No serious adverse events or adverse device events were reported. Conclusions The use of a 2.9 mm diameter bone-level-tapered implant is a safe and reliable treatment option for narrow tooth gaps at the indicated locations. Overall performance and good survival rates support their use in cases, where wider implants are unsuitable. Graphical abstract

Clinical, radiographic, and aesthetic outcomes at two narrow‐diameter implants to replace congenital missing maxillary lateral incisors: A 3‐year prospective, clinical study

“…Overall, the 3-year results are consistent with those published after 12 months of loading: more specifically, no additional implants were lost underlining the reliability of both implants for tooth replacement in single-unit gaps not also in the midterm. Our results are slightly better than those recently published by Walter et al 13 who reported an implant survival rate of 92.7% at 1 year after placement of 41 2.9 mm diameter implants. Possible explanations could be found in the differences in inclusion and exclusion criteria, the use of such an implant in different clinical scenarios (i.e., maxillary and mandibular incisors) and the fact that all patients in the present study were young and healthy.…”

“…12 Very recently, the clinical safety and performance of 2.9 mm NDIs in different clinical scenarios (i.e., maxillary and mandibular incisors) was documented by Walter and co-workers in a multicenter study reporting a 92.7% of implant survival rate after 1 year of loading. 13 Focusing on mid-term outcomes (i.e., with a follow-up of 3 years), satisfactory results have been published in two prospective clinical studies on NDIs with 3.0 mm 14 and 3.3 mm, 15 respectively. However, due to the lack of a control group and the limited number of patients included, the overall validity of the data obtained could be questioned.…”