Study population and measures

The study was designed as a prospective monocentric longitudinal cohort study according to the STROBE criteria. The participants of this study were recruited at the university hospital of Martin Luther University Halle-Wittenberg, Department of Oral and Plastic Maxillofacial Surgery, implantological consultation from 2014 (June) until 2015 (June). Inclusion and exclusion criteria of adult patients interested in implantological treatment are summarised in Table 1. Written informed consent was obtained from all individual participants included in this study.

As a “proof of concept”, the pilot study was designed to investigate the intraoperative handling and to evaluate the feasibility and safety of a new short implant system. Therefore, sample size calculation was not performed. The primary outcome variable was implant success rate, which was calculated considering known success criteria (implant in function, no sign of infection or pain, no mobility, no radiolucent area around the implant). The implant survival was calculated according to the Kaplan-Meyer method. Secondary measures were implant stability (initial and secondary) and periimplant crestal bone changes. Implant stability was measured by resonance frequency analysis (RFA; Osstell AB, Göteborg, Sweden).

Primary stability was measured immediately after implant insertion and completed expansion (see below), and secondary stability after the submerged healing period (3 months in the mandible, 6 months in the maxilla; Table 2) during the re-entry operation just before the healing abutments were inserted. Implant stability quotient (ISQ) values were obtained using the Smartpegs (type 17 and 35). According to each measurement, implant stability was classified as low with ISQ values < 60, medium with ISQ values 60–70, and high with ISQ values > 70.

Digital radiograms (orthopantomogram, standard periapical radiograms) were taken prior to surgery, after implant insertion and re-entry, and at yearly follow-up examinations for crestal and periapical bone evaluation (see below).

Implants

In this study, a short expandable titanium screw implant (PYRAMIDION dental implant, DenTack Implants Ltd., Kfar-Saba, Israel) was used, which leads to dynamic condensing of the apical bone. The implants had the following dimensions and special characteristics: 5, 6 and 7 mm in length, 3.75 and 4.1 mm in diameter and an internal (7-mm length) or external (5- and 6-mm length) hexagon platform. The apical expansion is performed after implant insertion using a special expansion tool and a ratchet torque, resulting in a pyramid shape (Fig. 1a-f). The implant expansion process using the expansion tool is visualised in the movie clip (Additional file 1).

Simulation of the expansion process. At the end of the expansion process, a minimal snap back is realised. (MP4 9407 kb)