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 (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 ± 7.8 years; EG: n = 19, age = 70.3 ± 10.7 years). 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 = .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).
Keywords: dental implants; dental prosthesis; denture; humans; implant-supported; prosthodontics; randomized controlled trials [MeSH topic].
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