Mandibular two-implant overdentures with CAD-CAM milled bars with distal extensions or retentive anchors: a randomized controlled trial.

Srinivasan, Murali; Schimmel, Martin; Buser, Ramona; Maniewicz, Sabrina; Herrmann, François R; Müller, Frauke (2020). Mandibular two-implant overdentures with CAD-CAM milled bars with distal extensions or retentive anchors: a randomized controlled trial. Clinical oral implants research, 31(12), pp. 1207-1222. Wiley-Blackwell 10.1111/clr.13668

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OBJECTIVE

This randomized controlled trial (RCT) aimed to demonstrate the noninferiority of mandibular 2-implant overdentures (IODs) on a CAD-CAM milled bar with long distal extensions (MBDE) against IODs on retentive anchors (RA).

METHODS

Forty edentulous participants rehabilitated with a maxillary conventional denture and a mandibular 2-IOD participated in this trial. They were randomized into two groups [Control group (CG): RA + gold matrices; Experimental group (EG): MBDE + gold clip]. The outcomes included implant survival rate (ISR), chewing efficiency [quantitative (VoH) and subjective (SA) assessments], peri-implant marginal bone-levels (PI-MBL), maximum bite-force (MBF), and patient-reported outcomes [oral health impact profile (OHIP-EDENT) and denture satisfaction index (DSI)]. Outcomes were recorded at baseline (BL), two weeks (T0 ), 6-months (T1 ) and at 1-year (T2 ) after the intervention. Intra- and inter-group analyses were performed using regression models with ⍺=0.05.

RESULTS

38 participants completed the T2 visit (CG: n=19, age=74.7±7.8y; EG: n=19, age=70.3±10.7y). At T2 , there was no implant loss in either of the groups (ISR=100%). There were no significant differences between the groups for the PI-MBL changes (p=0.754). Improvements occurred faster in the EG than in the CG, but over the observation time, there were no differences between the trial groups for VoH, MBF, OHIP-EDENT, and the DSI, except for SA being significantly better in the EG group (p=0.022).

CONCLUSIONS

The results of this RCT confirm that mandibular 2-IODs with a CAD-CAM milled bar with long distal extensions are not an inferior treatment to the conventional IODs on retentive anchors in the short term (1-year).

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