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A clinical study at the Texas A&M University Baylor College of Dentistry is gathering data for the U.S. Food and Drug Administration about a tooth replacement system that is already available in Europe.
The REPLICATE Immediate Tooth Replacement System is a new approach to single-tooth replacement and is said to offer patients an immediate, minimally invasive alternative to traditional dental implants and three-unit bridges.
Made of titanium and zirconia, the Replicate tooth is an anatomical copy of the patient’s natural tooth — made using data obtained from a 3-D X-ray — that fits into the space occupied by the tooth being extracted.
The customized Replicate tooth allows general dentists and specialists to place it into the extraction site and protect it by attaching a tooth-shaped cover shield to the adjacent teeth, so the patient never goes without a tooth. After six months, the Replicate tooth is fully restored with a crown.
Next steps to bring the product to the U.S. market include integration tests, which will be conducted a year after each patient’s Replicate tooth is placed. Texas A&M researchers will then submit final results to federal regulators. The system has been used in the European Union since 2013.
Elias Kontogiorgos, director of implant dentistry in restorative sciences, is principal investigator on the study, along with co-investigators Likith Reddy, associate professor and director of residency training in oral and maxillofacial surgery, and Lynne Opperman, Regents Professor in biomedical sciences and director of technology development.
“This will change how implants are done, mostly by shortening the treatment period,” Kontogiorgos said. “If patients qualify for a Replicate tooth, they will receive the implant the same day their tooth is removed. Current techniques generally call for a three-month healing period after extraction before the implant is placed. Dentists will have more options to give to their patients who still have a tooth in the socket.”
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