ABSTRACT
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 nâ¯=â¯42; SIMO nâ¯=â¯42) were included, out of which 70 completed the 12-month follow-up (CCD nâ¯=â¯34; SIMO nâ¯=â¯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.
Subject(s)
Denture, Complete , Denture, Overlay , Quality of Life , Dental Prosthesis, Implant-Supported , Denture, Complete, Lower , Follow-Up Studies , Humans , Mandible , Patient Satisfaction , Treatment OutcomeABSTRACT
OBJECTIVE: This prospective clinical trial aimed to assess clinical and patient-reported outcomes of the single-implant mandibular overdenture treatment (SIMO) after a 2-year follow-up period. MATERIALS AND METHODS: An external hexagon implant was inserted in the mandibular midline of 45 complete denture wearers. Participants had a mean age of 63.4 (SD = 8.3), and 75.6% were female. Based on the primary stability of the implant, immediate loading was performed in 38 patients (84.4%). O'ring/ball attachments were used for retention. Outcome assessment included the participants' satisfaction with the dentures and oral health-related quality of life (OHRQoL) impacts at the 3-, 6-, 12-, and 24-month follow-up visits after implant loading. Moreover, all prosthodontic events were recorded during this period. RESULTS: The post-loading implant survival rate was 95.3%. There was a significant increase in satisfaction with the mandibular overdenture (p < .001) and a decrease in the overall OHRQoL impacts (p < .001) in the 3-month follow-up. No significant changes were observed between the 3- and 24-month follow-ups. The incidence of prosthodontic events was relatively high, including the need for matrix replacement and repair of the overdenture fracture. Most prosthodontic complications were minor and properly managed in periodic recall visits. CONCLUSIONS: Single-implant mandibular overdenture is a feasible alternative for subjects poorly adapted to the mandibular denture and resulted in significant improvement in patient satisfaction and quality of life measures. A careful selection of patients based on their demanding needs and expectations is essential to indicate this alternative. The incidence of maintenance events in the long term reinforces the need for periodical clinical monitoring.