Tooth Extraction Status Nos Clinical Trial
Official title:
Single Tooth Extraction in Damaged Alveoli and Implant Site Development Randomized Controlled Clinical Trial Comparing Socket Preservation and Reconstruction Surgery to Spontaneous Healing
It is unclear what is the best approach to implant site development after tooth extraction when the pathology leading to extraction has damaged the alveolus. The main objective of this study is to assess if socket preservation and/or reconstruction surgery provides a clinical benefit in terms of ability to place an implant in a prosthetically guided position in such clinical conditions. The PICO question therefore is: In patients requiring single tooth extraction what is the benefit of socket preservation/reconstruction surgery with respect to spontaneous healing in terms of feasibility and ease of implant surgery?
This will be a parallel group, standard of care-controlled, assessor-blind, randomized, multicenter, clinical trial. The statistical design will be a superiority trial in terms of the primary outcome with reference to the standard of care control (spontaneous healing). Primary outcome: Possibility to place an implant in a prosthetically driven position with or without bone or soft tissue augmentation 16-20 weeks after tooth extraction, evaluated at planning with cone beam CT and confirmed at surgery. ;
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