Clinical Research Directory

The Use of a Fully Digital Workflow in Immediate Implants With Immediate Restoration

Sponsor: Proed, Torino, Italy

Summary

Study hypothesis The hypothesis is that a full-digital workflow for immediate implant placement with immediate restoration is able to provide at least the same outcomes as standard analog implant placement in the same clinical scenario (immediate placement with immediate loading), in terms of implant success and survival and marginal bone level stability. A VAS scale evaluation will be created to measure patients' aesthetic and overall satisfaction, as well the duration of the procedure will be measured. Type of study Clinical Study design Prospective, single-arm using BLC implants with full digital workflow. Patients treated within "Clinical and radiological evaluation of a novel implant design (Straumann BLX) in the esthetic zone: a prospective case series study" (IIS 43/17), published as "Cardaropoli D, Tamagnone L, Roffredo A, Demaria A. Clinical and radiological evaluation of a fully tapered implant with immediate placement in the aesthetic zone: a prospective case series study. Int J Periodontics Restorative Dent. 2022 Sep-Oct;42(5):631-637" will be used for comparison. Study power N total: 24 Anticipated drop-out rate %: 15 Adequate power analysis and justification A power calculation before the study revealed that a sample size of 20 was necessary to detect a difference of 0.5 mm in the vertical position of the implant between planning and execution of 0.5 mm assuming a maximal standard deviation of 0.7 mm using a paired t test with 80% power and .05 level of significance. Study intervention - test arm Study Device BLC Implant Test treatment name Fully digital immediate placement/immediate restoration Test Treatment description An immediate BLC implant inserted in post-extraction sites in the upper maxilla, from 15 to 25, with immediate restoration. Primary outcome parameter Pink Esthetic Score (PES from 0 to 14), at 1 year Marginal Bone Level expressed in mm, at 1 year Secondary outcome parameter PROMS - Patients' satisfaction using VAS scale, at day of surgery and at 1 year Duration of the procedure, at day of surgery Probing Depth (PD) and Bleeding on Probing (BoP) at 1 year Materials and Methods Population and indication 24 adult systemically healthy patients requiring tooth extraction and single implant tooth replacement, from 1.5 to 2.5 Treatments In the case study phase, a 3D cone-beam radiograph and an intraoral scan are acquired. A computer guided surgical stent is produced from the virtual planning. By sharing the virtual planning, the laboratory designs and produces a temporary crown. On the day of surgery the tooth is extracted, the implant is inserted and the temporary is delivered. The final ceramic crown is delivered 3 months later. Follow-up will end 1 year after implant placement.

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