Mandibular two‐implant overdentures with CAD‐CAM milled bars with distal extensions or retentive anchors: A randomized controlled trial

Abstract Objective This randomized controlled trial (RCT) aimed to demonstrate the non‐inferiority 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 (T 0 ), 6 months (T 1 ), and at 1 year (T 2 ) after the intervention. Intra‐ and inter‐group analyses were performed using regression models with ⍺=0.05. Results 38 participants completed the T 2 visit (CG: n = 19, age = 74.7 ± 7.8 years; EG: n = 19, age = 70.3 ± 10.7 years). At T 2 , 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 = .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 = .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).