LAUSR

OBJECTIVE This randomized clinical trial (RCT) aimed to assess the 1-year effectiveness of single-implant mandibular overdentures (SIMO) compared to conventional complete dentures (CCD). METHODS In the first phase of the study, participants received new maxillary and mandibular CCDs. Then, they were randomly allocated to one of the study groups (CCD or SIMO). Participants in SIMO group received an external hexagon implant in the mandibular midline, with the immediate connection of an O-Ring/ball attachment. Oral health-related quality of life (OHIP-EDENT) and patient satisfaction in both groups were assessed before allocation and at 6- and 12-month follow-up visits. Both intention-to-treat (ITT) and per-protocol approaches were used for analyses. Statistical analyses were performed using the Wilcoxon Signed Ranks test and the Generalized Estimating Equations. RESULTS Eighty-four participants (CCD n = 42; SIMO n = 42) were included, out of which 70 completed the 12-month follow-up (CCD n = 34; SIMO n = 36). ITT analysis showed no changes for the CCD group in the longitudinal assessment compared to baseline. Participants in SIMO group had a significant improvement in OHIP-EDENT scores and satisfaction with the mandibular denture. No changes for the maxillary denture were observed in either groups. Similar results were found when per-protocol analysis was performed. CONCLUSIONS SIMO treatment resulted in a significant improvement in patient perceived outcomes compared to the CCD. SIMO may be considered as an alternative treatment modality for patients with poorly adapted and/or unstable mandibular dentures (ClinicalTrials.gov NCT03463174). CLINICAL RELEVANCE The immediately loaded single-implant mandibular overdenture markedly improved patient satisfaction and oral health-related quality of life of conventional denture wearers after a 12-month follow-up.