Four-year assessment of masticatory function in mandibular overdenture wearers: A randomised clinical trial comparing two to four implants to retain the prosthesis.

ABSTRACT

BACKGROUND: Limited data exist on the mid- to long-term masticatory capacity of mandibular overdenture (IOD) wearers, particularly regarding the use of posterior implants to retention. OBJECTIVES: To periodically evaluate mastication of IOD wearers, comparing the effectiveness of two to four implants to retain the prosthesis. METHODS: In a randomised controlled clinical trial, 20 complete edentulous patients (14 women), aged 51-84 years (mean age 69.1 ± 9.6), received new bimaxillary complete dentures (CD). After adaptation, baseline measurements of masticatory performance (X50) and swallowing threshold were conducted using the sieving method. Patients were then randomly assigned to groups control (two intra-foraminal regular implants) and experimental (two intra-foraminal regular implants and two extra-short posterior implants) (n = 10 each). After 4 months, implants were splinted, and a new mandibular IOD was fabricated with bar/clip retention. Mastication was reassessed after 6, 12, and 48 months, and data analysed with repeated measures ANOVA and Sidak's post hoc (α = 0.05). RESULTS: Despite a loss of two patients per group, masticatory performance significantly improved after mandibular IOD installation (p = .031) in both groups (p = .670). A second improvement was observed after 6 months (p = .027), with no subsequent changes (p > .05). Swallowing threshold improvements were noted with IOD, and no discernible differences between groups were observed (p > .05). CONCLUSION: Masticatory function significantly improved after mandibular IOD installation, with the number of implants demonstrating minimal influence. CLINICAL TRIAL REGISTRATION The present study was not registered in a public database, as mandated. It is important to note that the recommendation for registration was initiated in 2017 by the Committee of Medical Journal Editors, while patient inclusion in the research took place in 2016. Given that the data presented in this manuscript cover a follow-up period of up to 4 years post-surgical intervention, delayed registration was not feasible.