Study of Periodontal Ligament-Integrated Implants Placed Immediately After Single-Rooted Tooth Extraction to Restore Natural Tooth Function and Stability

What this Trial Is About

Researchers are evaluating a new type of dental implant called a periodontal ligament-integrated implant for adults aged 18 and older who need a single-rooted tooth extracted. This exploratory study aims to assess whether this implant can successfully integrate with the jawbone 24 weeks after placement and if it can restore natural tooth functions such as mobility and sensory feedback while maintaining periodontal health. The implant uses residual periodontal ligament tissue in the extraction socket to promote functional attachment, differing from traditional implants that rely solely on bone integration. Participants will undergo extraction of one single-rooted tooth followed immediately by placement of the investigational implant stabilized with a temporary fixation device. This fixation remains for about nine weeks to allow healing and integration. Afterward, a superstructure is placed for controlled chewing load, and the fixation device is removed once stable integration is confirmed. The study involves multiple follow-up visits over 48 weeks, with ongoing oral care and monitoring. During the study, participants will have dental X-rays, CT scans, and clinical exams to evaluate bone healing, periodontal ligament formation, implant stability, and tooth mobility. Researchers will also measure periodontal pocket depth, pain levels, and assess patient quality of life using oral health questionnaires. Safety and implant performance will be closely monitored, with assessments continuing up to 48 weeks to gather comprehensive data on the implants biological feasibility, mechanical behavior, and clinical safety.

Efficacy and Safety Evaluation Study of Implants With Periodontal Ligament