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A Guide to Conducting Randomized Clinical Trials in Implantology: Lessons From a Clinical Trial Investigating the Implant Performance in Overdenture Wearers Submitted to Conventional and Immediate Loading

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By: & Published: 2020 | Product: SAGE Research Methods Cases: Medicine and Health
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Abstract

This methods case will deal with problems related to randomized clinical trial design in implantology. More specifically, we will discuss randomized clinical trial designs that investigate the improvements provided by conventional and immediate occlusal loading protocols using mandibular overdentures retained by narrow dental implants in populations of completely edentulous patients with prolonged time since edentulism. Most clinical studies available present different methodological characteristics, and many do not show aspects aligned with current research practices, especially where immediate loading is concerned. Immediate loading requires high primary stability, which can be clinically assessed by insertion torque values provided by the surgical motor and by the implant quotient stability value through resonance frequency analysis. Controversies are being observed in regard to this clinical concept, both related to decisions based on the insertion torque obtained during implant installation and by the implant quotient stability. Furthermore, immediate loading induces more strain to the peri-implant bone earlier, but allows faster transition to implant-retained overdentures, improving the oral-health related quality of life. In addition, the use of the CONSORT Statement is discussed to facilitate randomized clinical trial planning in such target population. Finally, some clinical comparisons in this research field are presented alongside common logistical problems encountered during this type of randomized clinical trial development.

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