Fixed full-arch maxillary prostheses supported by four versus six implants with a titanium CAD/CAM milled framework: 3-year multicentre RCT.

OBJECTIVES

This RCT compares marginal bone level (MBL) change and the clinical parameters after a 3-year function in maxillary implant-supported fixed complete dentures (FCDs) treated with four-implants (4-I) or six-implants (6-I).

MATERIAL AND METHOD

Three centres treated 56 patients with 280 implants allocated to the 4-I or 6-I group. Radiographic and clinical examinations were performed. The primary outcome was to investigate MBL change between the groups.

RESULTS

Implant survival rates were 100% and 99% in the 4-I and 6-I groups, respectively. Considering the clustering effects, the MBL change was not significantly different between the groups over the 3-year follow-up. The MBL in the 4-I group was 0.30 ± 0.50 mm at baseline, 0.24 ± 0.31 mm at 1 year and 0.24 ± 0.38 mm at 3 years. In the 6-I group, MBL was 0.14 ± 0.32 mm at baseline, 0.16 ± 0.35 mm at 1 year and 0.12 ± 0.26 mm at 3 years. There was a statistically significant difference between the groups at BL and 3Y. No significant differences between the groups were reported for clinical parameters at each time point as well as in between the visits. The technical and biological complications rates were 1.6% and 6.0%, respectively. Prosthetic complications affected 25 FCDs (47.2%).

CONCLUSION

Marginal bone level change revealed a stable condition in the 3-year period in the two groups. Few technical and biological complications occurred apart from the chipping/fracture of the prosthetic teeth. Four-implant is a feasible solution if the rehabilitation is oriented towards the most cost-effective treatment and towards avoiding bone augmentation procedures. Clinicians have to consider the potential required visits for prosthetic maintenance.