Efetividade e custo-efetividade de três alternativas de tratamento para reabilitação do desdentado mandibular: ensaio clínico randomizado com acompanhamento de 1 ano

Abstract

This randomized trial compared the effectiveness and cost-effectiveness (cost x patient centered outcomes) of three treatment alternatives for mandibular edentulism rehabilitation: unit-implant-retained mandibular overdenture (Group I), two-implant-retained mandibular overdenture (Group II) and four-implant-supported mandibular fixed prosthesis (Group III). We included 50 fully edentulous patients who initially received new conventional total dentures (baseline) and were later randomly allocated to one of the treatment groups. External hexagon implants (Titamax TI Cortical, Neodent, Curitiba, Brazil) were installed following the conventional loading installation protocol. Generalized Estimating Equations (GEE) was used to calculate the primary outcome variables were the direct dental costs which were identified, measured and valued; oral health-related quality of life (OHIP-Edent) and patient satisfaction with prostheses in all groups for a follow-up period of 1 year. Masticatory performance, prosthetic complications, maintenance events and peri-implant evaluation (marginal bone loss, peri-implant tissue status, implant stability quotient - ISQ) were evaluated as secondary outcomes. Data from 37 participants: Group I (n = 11); Group II (n = 13); Group III (n = 13) were collected and were similar in relation to baseline clinical characteristics and outcomes of initial treatment with conventional full dentures. Incremental cost-effectiveness - ICER ranged for Group II (compared to Group I) from R$ 36.20 to R$ 81.46 for a 1-point increase in patient satisfaction (base value = R$ 54.30) for Group III (compared to Group I) ranged from R$ 1321.12 to R$ 2972.52 (base value = R$ 1981.68). The total cost of treatment for the surgical and prosthetic phases was R$ 2,370.70 for Group I, R$ 3,185.20 for Group II and R$ 5,739.50 for Group III. There was a significant difference between the costs in the three groups (p <0.001). The greatest impacts on total treatment cost were related to the initial laboratory, implant and component costs in Group III. The satisfaction questionnaires and OHIP-Edent satisfaction scores in the 12 months improved in all groups compared to baseline. and were similar in intergroup comparison at baseline (with new conventional full dentures) and 1 year after implant prosthesis capture. In intra- and inter-group comparisons there was no significant change regarding satisfaction with the maxillary prosthesis. Regarding masticatory performance, there was no difference between groups evaluated in the same period for the different cycles (20 and 50 cycles) with gradual improvement for all groups up to 6 months and a slight decrease in 12 months for all groups. It was concluded that the rehabilitation of edentulous patients with implants significantly improved patient-reported outcomes in all treatment groups. Regarding the economic aspects of the treatments, the direct dental cost and the clinical time spent to perform the treatment and follow-up during the 1 year period in the fixed prosthesis (Group III) was approximately three times higher than in Group I, which did not correspond to a proportional gain in effectiveness as well as the additional cost of overdenture retained by two implants did not result in significant effectiveness gain over overdenture retained per unit implant. The implant survival was 100% in all groups after the 1-year follow-up. Considering the limitations of the study, implant-retained overdentures were the most cost-effective modalities.