Clinical and radiographic evaluation of locator R-Tx attachments for two implants supported mandibular overdenture using two loading protocols; A randomized clinical trial.

Abstract

Purpose: This study was conducted to evaluate clinically and radiographically locator R-TX attachments using two different loading protocols for implant-supported mandibular overdenture. Material and Methods: Thirty edentulous patients (a total of 60 implants) received two implants interformenally in the canine area. Patients were divided randomly (using balanced randomization) into two equal groups in accordance with the loading process utilized to attach the mandibular overdenture. Group I (control): Patients received traditional loading protocol with a mandibular implant overdenture retained in place by two RTx locator attachments (after 3 months from implant placement). Group II (study): Patients received early loading protocol with a mandibular implant overdenture retained in place by two RTx locator attachments (at 6th week after implant placement). No implants were lost in the study. After denture placement (T0), six (T6), and twelve (T12) months later, the peri-implant tissue health [Plaque (PL) and (GI) gingival scores, pocket depth (PD) in mm, and crestal bone loss (CBL) in mm] was assessed. Results: After one year, no statistically significant difference was found in peri-implant tissue health parameters [(PL), (GI), (PD), and (CBL)] at all observation times and between both groups. Conclusion: Given the sample size limitations on this study, it is possible to reach the following conclusion: RTx locator is a promising attachment system especially when an early loading protocol is planned to be used regarding peri-implant tissue parameters. More randomized clinical studies are needed to confirm the clinical predictability of Rtx locator attachments.