Randomized controlled trial on the efficacy of a custom-made, fully guided implant system for flapless crestal sinus floor elevation: Accuracy and patient-reported outcomes

Abstract

Objective: To compare fully guided flapless implant surgery using a light-cured surgical guide (FG group) with partially guided open flap surgery (PG group) in the posterior maxilla when performing simultaneous sinus floor elevation in terms of the accuracy, time requirements, and patient/clinician-reported outcomes (PROMs and CROMs).

Materials and methods: In this study, 56 tissue-level implants were placed with crestal sinus floor elevation in 56 patients at single-tooth sites, with 28 implants allocated to the PG group and 28 to the FG group. The deviations of the placed implants from the virtually planned positions were measured at the implant platform and apex and for the angular deviation. The presurgical preparation time and the duration of surgery were measured. PROMs and CROMs were made by administering questionnaires at multiple time points.

Results: Horizontal deviations at the platform and apex and the angular deviation were significantly smaller in the FG group than the PG group (p < .05). Presurgical preparation and surgery times were significantly shorter in the FG group (p < .001). Patient satisfaction and willingness to receive repeat treatment were significantly better in the FG group than in the PG group (p < .005 and .025, respectively). Clinicians were more satisfied in the FG group than the PG group (p < .05).

Conclusion: When placing an implant with sinus floor elevation, the flapless approach using a fully guided surgical system can be more accurate, faster, and increase the satisfaction of both the clinician and patient compared to the partially guided surgery.

Keywords: clinical trial; dental implants; maxillary sinus floor elevation; randomized controlled trial; surgical techniques.

FIGURE 1

Simultaneous crestal sinus grafting procedures with implant installation using the partially guided system (PG group, a–d) and fully guided system (FG group, e–h). (a, e) Clinical situation before implantation. (b) After flap elevation and surgical stent application. (c) Implant fixture installation after the crestal sinus grafting procedure. (d) Postoperative situation in the PG group. (f) Soft‐tissue punching using a full surgical guide in the correct position. (g) Implant fixture installation at the correct depth and position using the fully guided surgical system after crestal sinus floor elevation and the grafting procedure. (h) Postoperative situation in the FG group.

FIGURE 2

Schematic images showing measurement procedures for the deviations in implant fixture positions in the PG group (a–f) and FG group (g–l). (a, g) Virtual planning of implants on a CBCT image. (b) Virtual abutment derived with the virtually planned fixture position in the PG group. (h) Superimposed STL file of the virtual surgical guide at the virtually planned implant position in the FG group. (c, i) STL file after connecting a ready‐made scan body to the actually placed implant. (d, e, j, k) After superimposing the two STL files in (b) and (c), implant positions were derived using computer software. (f, l) Deviations of positions and angles were measured.

FIGURE 3

Positional accuracy of the implant fixtures. In each scatter plot, the long horizontal line indicates the mean, the short horizontal line indicates the 95% confidence interval, and the scattered dots indicate the analyzed individual deviation of the actually placed implants. (a) Horizontal platform deviation. (b) Horizontal apex deviation. (c) Angular deviation. (d) Vertical platform deviation. (e) Vertical apex deviation. An asterisk (*) indicates a statistically significant difference between groups.

FIGURE 4

Scatter plots showing the positions of the horizontally deviated platform, horizontally deviated apex, and direction and the magnitude of the angular deviation. (a) Horizontally deviated platform position of the actually placed implants. (b) Horizontally deviated apex position of the actually placed implants. (c) Direction and amount of angular deviation of the actually placed implants. Vertically deviated platform and apex positions are shown in Figure 3d,e.

FIGURE 5

PROMs from a questionnaire with seven questions answered on an NRS from 0 to 10. Data are means and 95% confidence intervals. Patient satisfaction and willingness to receive repeat treatment at 12 weeks after surgery differed significantly between the two groups (p < .05).

FIGURE 6

CROMs from a questionnaire with seven questions answered on a NRS from 0 to 10. Data are means and 95% confidence intervals. All data values differed significantly between the two groups (p < .05).